Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate GREATER MANCHESTER GUIDELINE FOR: THE DIAGNOSIS, INVESTIGATION AND MANAGEMENT OF ABNORMALLY SWOLLEN OR PAINFUL LEG(S) Page 1 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate NHS England Greater Manchester, Lancashire, South Cumbria Strategic Clinical Network & Senate First published: July 2013 Prepared by: Gareth Lord - Quality Improvement Manager – SCN (Gareth.lord@nhs.net) Derived from: The ‘Greater Manchester guideline for the investigation and treatment of suspected deep vein thrombosis consultation paper’ developed by Mark Holland (MarkEdward.Holland@uhsm.nhs.uk) and the DVT Steering Group, NICE Guidance (Venous thromboembolism: Reducing the Risk - CG 92, Venous thromboembolic diseases: the management of venous thromboembolic diseases and the role of thrombophilia testing – CG 144, Quality standard for diagnosis and management of venous thromboembolic diseases – QS 29) and the National VTE Prevention Programme website Version: Date: Intended Audience: Variation from 1.2 Version 2 24th April 2014 DVT Steering Group, Heads of Commissioning, Operational Managers, GP’s, Acute Physicians, Clinicians involved in investigating, diagnosing or managing DVT, Other Interested Stakeholders, Extended pathway to include post hospital DVT guidance; Aligned more to GP Guide which is also included in the appendix; Added section on ‘Not DVT’; highlighted treatments that should be considered as an option for first line; adjusted so easier to read. Page 2 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Contents Introduction .................................................................................................................................3 Terms used in this guidance and note for GP’s ...........................................................................5 Pathway for the diagnosis, investigation and management of abnormally swollen or painful leg(s) ...........6 Patient presentation ....................................................................................................................7 Baseline tests ...........................................................................................................................10 Pursue further tests ...................................................................................................................11 Diagnosing DVT ........................................................................................................................13 Discharge..................................................................................................................................20 Patient information ....................................................................................................................20 Patient with signs and symptoms of both DVT and PE ..............................................................21 Appendix 1: Two-Level DVT Wells Score .................................................................................25 Appendix 2: GP referral form....................................................................................................26 Appendix 3: Algorithm for investigating a suspected DVT ........................................................28 Appendix 4: Discharge pro-forma .............................................................................................29 Appendix 5: Patient Information booklet ...................................................................................33 Appendix 6: Prescribing guideline ............................................................................................44 Appendix 7: Prescribing checklists for clinicians .......................................................................48 Appendix 8: GP guide ..............................................................................................................50 Introduction Venous thromboembolism (VTE) is a clinically important condition. Left untreated, VTE is potentially fatal. In clinical practice there are two main forms of VTE disease, deep vein thrombosis (DVT) of the lower limbs or pelvis and pulmonary embolism (PE). Other forms of venous thrombosis are less common, and include axillary and subclavian vein thrombosis affecting the upper limbs, or cavernous and sagittal thrombosis affecting the brain. Failure to diagnose and treat VTE correctly can result in fatal PE. However, diagnosis of VTE is not always straight forward, pathways and tests can be inconsistent and there is in most cases no clear responsible clinician or co-ordinator to manage the patient though the pathway. As a consequence, quality of care can vary and conditions or underlying cause Page 3 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate can remain undetermined. Many staff are trained only to reach the diagnosis of DVT and subsequently discharge symptomatic patients without ever explaining the symptoms. Commissioners do not have assurance that best practice is being followed by providers to minimise the risk of a VTE, to diagnose VTE rapidly and treat appropriately. It was therefore, necessary to evaluate current protocol and guidance and to develop a new guideline and pathway to manage patients with suspected VTE (more specifically DVT) within Greater Manchester. This guideline has been developed by the Greater Manchester DVT Steering Group and builds on existing NICE guidance to: To ensure the patients symptoms are diagnosed as opposed to just confirming or excluding a DVT Provide ownership and consistency using clinical evidence Provide a step by step pathway and DVT algorithm Provide a better patient experience by seeking and treating the cause of the patient’s symptoms Key differences between this guideline and NICE guidance: This guideline suggests the provider has a ‘Hospital DVT/VTE Service’ run by professionals trained and experienced in VTE. These professionals will take responsibility of managing the patient throughout the pathway. The d-dimer in this guideline is taken with the baseline tests for all patients. This guideline suggests performing a full leg length venous duplex ultrasound instead of a proximal leg vein ultrasound. This guideline uses an algorithm to risk stratify patients based on the changes to the aforementioned diagnostics. This guideline suggests an additional set of provocation factors are taken in to account when considering provocation To be used in conjunction with NICE guidance on Venous thromboembolism: Reducing the Risk (NICE clinical guideline 92), Rivaroxaban for the prevention of venous thromboembolism after total hip or total knee replacement in adults and Dabigatran etexilate for the prevention of venous thromboembolism after hip or knee replacement surgery in adults. It is important to note that this document acts as a guide for clinicians, investigating, and diagnosing and managing patients first presenting with an abnormally swollen and/or painful leg(s). In a small number of cases, it is accepted clinicians may feel it necessary to deviate from this pathway based on their clinical knowledge, experience and judgement. Page 4 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Terms used in this guidance D-dimer test D-dimer is a product formed in the body when a blood clot (such as those found in DVT or PE) is broken down. A laboratory or point-of-care test can be done to assess the concentration of D-dimer in a person's blood. The threshold for a positive result varies with the type of D-dimer test used and is determined locally. The result of the D-dimer test can be used as part of probability assessment when DVT or PE is suspected. International normalised ratio (INR) A standardised laboratory measure of blood coagulation used to monitor the adequacy of anticoagulation in patients who are having treatment with a vitamin K antagonist. Provoked DVT or PE in a patient with an antecedent (within 3 months) and transient major clinical risk factor for VTE – for example surgery, trauma, significant immobility (bedbound, unable to walk unaided or likely to spend a substantial proportion of the day in bed or in a chair), pregnancy or puerperium – or in a patient who is having hormonal therapy (oral contraceptive or hormone replacement therapy). Proximal DVT DVT in the popliteal vein or above. Proximal DVT is sometimes referred to as 'above-knee DVT'. Renal impairment Reduced renal function that may be acute or chronic. An estimated glomerular filtration rate of less than 90 ml/min/1.73 m2 indicates a degree of renal impairment in chronic kidney disease. (For NICE guidance on the classification of chronic kidney disease see Chronic kidney disease [NICE clinical guideline 73]). Unprovoked DVT or PE in a patient with: no antecedent major clinical risk factor for VTE (see 'Provoked deep vein thrombosis or pulmonary embolism' above) who is not having hormonal therapy (oral contraceptive or hormone replacement therapy) or active cancer, thrombophilia or a family history of VTE, because these are underlying risks that remain constant in the patient. Wells score Clinical prediction rule for estimating the probability of DVT and PE. There are a number of versions of Wells scores available. This guideline recommends the two-level DVT Wells score and the two-level PE Wells score. GP’s For a complete pathway guide from a GP perspective, refer to appendix 8. Page 5 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate A&E (a2) On hospital ward (a3) Pursue further tests Hospital DVT/VTE Service (b) Provide or pursue an alternative diagnosis (c2) Ultrasound (c1) Diagnosis of DVT Review post ultrasound scan (d) Proven DVT (d1) Discharge DVT unexplained (d1.1) Pursue Furtherfurther tests totests find to reason find reason for DVT for DVT (e1) (e1) Not DVT (d2) DVT explained (d1.2) Alternative diagnosis (d2.1) Return to GP or ward (e2) (d2.1) Referral to continue to pursue alternative diagnosis (e3) Review of treatment where necessary (f1) * Patient with abnormally swollen or painful leg(s)* identified as newly abnormal swollen or painful leg(s) or newly noticeable/significant swelling or pain on already swollen or painful leg(s). Community DVT service if one exists locally** - refers to a DVT service in a central location in the community that provide baseline tests and aim to reduce hospital admissions. A1b is additional to this pathway. Page 6 of 67 Responsibility of the Health Professional within the Hospital DVT/VTE Service Community DVT service if one exists locally** (a1b) Responsibility of those referred to GP (a1) Responsibility of the referrer Patient with abnormally swollen or painful leg(s)* Baseline tests Patient Presentation Pathway for the diagnosis, investigation and management of abnormally swollen or painful leg(s) Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Breakdown of the pathway Patient presentation This section is for the clinicians to whom patients present with signs or symptoms of deep vein thrombosis (DVT), such as a swollen or painful leg(s). These include: GP’s A&E clinicians Outpatient clinicians Hospital ward clinicians Patient with abnormally swollen or painful leg(s)* GP (a1) Community DVT service if one exists locally A&E/OP Clinic (a2) On hospital ward (a3) Hospital DVT/VTE Service (b) Ultrasound (c1) GP (a1) (a1) Patient presents to GP Check symptoms Physical examination to exclude other causes Patients general medical history Exclusion criteria Two-level DVT Wells Score (appendix 1) At this point a decision is made whether or not a patient should commence on a DVT pathway. The distinction being: any patient with signs or symptoms in a lower limb suggesting DVT as a potential diagnosis. If a DVT is suspected but d-dimer cannot be provided locally – refer to community DVT service (if one available) or hospital DVT service using the referral pro-forma (appendix 2) as appropriate. Page 7 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Where d-dimer can be provided locally – refer to the remainder of the GP (a1) section. (a1a) Providing d-dimer locally Review baseline tests to determine if a patient should be sent for an ultrasound or an alternative diagnosis should be sort: Where DVT a possibility High Risk Wells score >=2 Low Risk Wells score <2 plus Where DVT unlikely Wells Score <2 plus Positive d-dimer Negative d-dimer For patients where DVT a possibility – (c1) refer for ultrasound Patients where a DVT is a possibility should be sent for an ultrasound scan as soon as possible. These patients should be offered an interim therapeutic dose of anticoagulation therapy if diagnostic investigations are expected to take longer than 4 hours from the time of first clinical suspicion. (NICE QS29:1) Prescribing Low Molecular Weight Heparin’s (LMWH) - exclusions There are some patients that may also have relative contraindications and therefore should not routinely be prescribed LMWH. These patients include: Already taking an anticoagulant – in such cases it would be unsafe to give further anticoagulants until a DVT is proven. A proviso to this approach would be in a patient taking an oral anticoagulant but where the INR is sub therapeutic (usually less than 2). Co-morbid diseases which preclude ambulatory management – in such cases a suspected DVT might be present with one or more other active conditions. It is not possible to define all possible scenarios and clinical assessment will be important, for example patients unable to rest and elevate the affected leg at home. Estimated GFR less than 30ml/min – the dose of LMWH will need to be adjusted, however it might be safer to treat such patients as in-patients. Leg Trauma – any history of leg trauma should alert the attending practitioner to the possibility of a muscle tear. In such cases the administration of LMWH could have disastrous consequences. Cannot comply with ambulatory administration LMWH via a District Nurse, daily visit to the Ambulatory Clinic or unable to self-administer. Dual anti-platelet therapy of Aspirin AND Clopidogrel. Page 8 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate For all of the relative exclusion criteria the attending health professional ANP will need to weigh-up the risk a DVT against the risk-benefit of LMWH, prior to a Ultrasound scan. Patients need to be informed heparins are of animal origin. If they are concerned about using animal products, the health professional should consider using synthetic alternatives based on clinical judgement and discussing their suitability, advantages and disadvantages. People with suspected deep vein thrombosis have all diagnostic investigations completed within 24 hours of first clinical suspicion (NICE QS29:2). For patients where DVT unlikely – (c2) seek alternative diagnosis Patients where the baseline tests reveal a DVT is unlikely should have arrangements made where an alternative diagnosis is either given or pursued. The only situation which would negate the need for an ultrasound scan is when there is an obvious alternative diagnosis. For patients where a DVT unlikely: end this specific pathway A&E/OP Clinic (a2)/ Hospital ward (a3) Attending A&E Physician/Consultant/Nurse to: Check symptoms Physical examination to exclude other causes Patients general medical history Exclusion criteria At this point a decision is made whether or not a patient should commence on a DVT pathway. The distinction being: any patient with signs or symptoms in a lower limb suggesting DVT as a potential diagnosis. Patient referred to the Hospital DVT/VTE Service. Go to ‘Hospital DVT/VTE Service (b)’ Page 9 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Baseline tests Hospital DVT/VTE Service (b) Provide or pursue an alternative diagnosis (c2) Ultrasound (c1) Hospital DVT/VTE Service (b) Receives patients from A&E, GP or hospital ward This section is for clinicians within the hospital DVT/VTE team only. From the moment a patient is seen by one of the health professionals within the Hospital DVT/VTE Service, the health professional is overall responsible for the care of the patient through the pathway to the point of discharge from the pathway. If DVT potential diagnosis, complete where not completed; Two-level DVT Wells Score Baseline blood tests including D-dimer, full blood count, clotting profile and Urea and Electrolytes (U&E). Review baseline tests to determine if a patient should be sent for an ultrasound or an alternative diagnosis should be sort (see below or algorithm in appendix 3). Where DVT a possibility High Risk Wells score >=2 Low Risk Wells score <2 plus Where DVT unlikely Wells Score <2 plus Positive d-dimer Negative d-dimer For patients where DVT a possibility Patients where a DVT is a possibility should be sent for an ultrasound scan. These patients should be offered an interim therapeutic dose of anticoagulation therapy if diagnostic Page 10 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate investigations are expected to take longer than 4 hours from the time of first clinical suspicion. (NICE QS29:1) Please refer to ‘Prescribing LMWH (exclusions)’ – pages 8 & 9 People with suspected deep vein thrombosis have all diagnostic investigations completed within 24 hours of first clinical suspicion (NICE QS29:2). For patients where DVT unlikely Patients where the baseline tests reveal a DVT is unlikely should have arrangements made where an alternative diagnosis is either given or pursued. The only situation which would negate the need for an ultrasound scan is when there is an obvious alternative diagnosis. Where an alternative diagnosis can be provided the patient should be discharged to the care of their GP with a discharge summary (appendix 4) and the necessary patient information unless the diagnosis suggests the patient should be referred to another health professional specialist first. Where an alternative diagnosis needs to be pursued, the patient should be referred to another health professional with a discharge summary and the necessary information and a letter is copied to the GP. Pursue further tests Waiting for Ultrasound more than 4 hours Prescribing Low Molecular Weight Heparin’s (LMWH) - exclusions If the ultrasound scan can be provided within 4 hours or baseline tests, there is no need to prescribe LMWH prior to the ultrasound scan. If the patient is due to wait over 4 hours for an ultrasound scan from the moment a scan is requested (this is considered the point of clinical suspicion) LMWH are advised. However, there are some patients that may also have relative contraindications and therefore should not routinely be prescribed LMWH. These patients include: Already taking an anticoagulant – in such cases it would be unsafe to give further anticoagulants until a DVT is proven. A proviso to this approach would be in a patient taking an oral anticoagulant but where the INR is sub therapeutic (usually less than 2). Co-morbid diseases which preclude ambulatory management – in such cases a suspected DVT might be present with one or more other active conditions. It is not possible to define all possible scenarios and clinical assessment will be important, for example patients unable to rest and elevate the affected leg at home. Estimated GFR less than 30ml/min – the dose of LMWH will need to be adjusted, however it might be safer to treat such patients as in-patients. Leg Trauma – any history of leg trauma should alert the attending practitioner to the possibility of a muscle tear. In such cases the administration of LMWH could have disastrous consequences. Page 11 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Cannot comply with ambulatory administration LMWH via a District Nurse, daily visit to the Ambulatory Clinic or unable to self-administer. Dual anti-platelet therapy of Aspirin AND Clopidogrel. For all of the relative exclusion criteria the attending health professional ANP will need to weigh-up the risk a DVT against the risk-benefit of LMWH, prior to a Ultrasound scan. Patients need to be informed heparins are of animal origin. If they are concerned about using animal products, the health professional should consider using synthetic alternatives based on clinical judgement and discussing their suitability, advantages and disadvantages. Ultrasound (c1) Perform full leg length scan with a venous duplex ultrasound. This should be undertaken by a health professional trained in performing this scan. People with suspected deep vein thrombosis have all diagnostic investigations completed within 24 hours of first clinical suspicion (NICE QS29:2); ideally 4 hours from request if possible. During working hours, the aim should be to obtain a same day ultrasound scan, negating the need for a dose of LMWH prior to the scan. Provide or pursue an alternative diagnosis (c2) If following the review of the baseline tests it is felt that a DVT is not likely, arrangements should be made to provide or pursue an alternative diagnosis. It is the responsibility of the Hospital DVT/VTE Service health professional seen by the patient to make arrangements seeking an alternative diagnosis if one cannot be provided. This can be done by requesting further tests, or referring /transferring a patient to another specialist service. For these patients, the DVT/VTE pathway ends. Review Post ultrasound scan (d) The post ultrasound scan should be carried out by a health professional trained in the care of DVT patients. Outcomes: Wells Score >=2 <2 >=2 >=2 <2 + + + + + D-dimer Positive Positive Negative Negative Positive + + + + + Ultrasound Positive Positive Positive Negative Negative Outcome Proven DVT Proven DVT Proven DVT Not DVT Not DVT Page 12 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate The aim of the post review is to provide a diagnosis or working diagnosis (if possible) following the results. If a proven DVT, the hospital DVT/VTE Service professional should determine why the patient developed the DVT. If not a DVT, an alternative working diagnosis must be provided or methods are sort to try and determine a working diagnosis. Diagnosing a DVT Review post ultrasound scan (d) Proven DVT (d1) DVT unexplained (d1.1) DVT explained (d1.2) Proven DVT (d1) All patients with a proven DVT will require: 1. Anticoagulation (where eligible) or other treatment 2. Medical Review 3. Stockings For patients with a proven DVT, it is important to determine if the DVT is either unexplained (unprovoked) or explained (provoked) – see explaining the DVT section on pages 17 -18 Furthermore, the clinician needs to determine if the patient has an old thrombus (see below), or if the DVT is recurrent (refer to page 19). Old thrombus If the patient has an old thrombus responsible for the symptoms, the patient needs to be referred to a haematologist to discuss their treatment and exit the pathway even if the old thrombus was known about. If the patient has an old thrombus not responsible for the symptoms, and the cause for the symptoms is still unknown, the patient needs to be referred to a haematologist and exit the pathway and also needs to be referred to another specialist for further investigation in order to diagnose the cause. In both of the above cases, the patient needs to be given as much information as possible, and provided with a copy of the discharge pro-forma, whilst the patient is referred. Page 13 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate 1. Anticoagulation (where eligible) It is recommended healthcare professionals discuss the choice of anticoagulant therapies with patients, taking in to account comorbidities and contraindications with the following exceptions: For patients with severe renal impairment or established renal failure (estimated glomerular filtration rate [eGFR] <30 ml/min/1.73 m2) offer unfractionated heparin (UFH) with dose adjustments based on the APTT (activated partial thromboplastin time) or LMWH with dose adjustments based on an anti-Xa assay. For patients with an increased risk of bleeding consider UFH. For patients with PE and haemodynamic instability, offer UFH and consider thrombolytic therapy (see recommendations 1.2.7 and 1.2.8 o pharmacological systemic thrombolytic therapy in pulmonary embolism). Anticoagulation therapy should be started as soon as possible (see prescribing guideline – appendix 6 and refer to anticoagulation checklists in appendix 7 & 8). For the purpose of this pathway - Rivaroxaban should be considered as an option for treating DVT first line where felt clinically appropriate and if the patient agrees; Warfarin should also be considered. The chosen medication should initially be prescribed by the secondary care team. It is important to note there are some inclusion and exclusion criteria for commencing oral anticoagulation as an outpatient. Inclusion criteria for outpatient oral anticoagulation Can safely comply with out-patient oral anticoagulation No clinical evidence or suspicion of pulmonary embolism Pain controlled Baseline INR less than 1.4 Exclusion Criteria for outpatient oral anticoagulation Excess alcohol consumption Previously unstable on oral anticoagulation IV drug abuser – frequently do not comply with follow-up Femoral or more proximal DVT with leg swelling (admit for observation at least 24 hours) Significantly deranged Liver Function Tests (add LFT to admission bloods) Baseline INR 1.4 or above Patients taking dual antiplatelet therapy e.g. Aspirin and Clopidogrel Thienopyridines e.g. Clopidogrel, Prasugrel, or newer anti-platelets e.g. Tirofiban Known bleeding tendency or coagulopathy Page 14 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate It should also be noted that in the case of Rivaroxaban – secondary care will provide the initial 21 day therapy at recommended dose and these patients should be reviewed ideally between day 14 and 21. Pregnancy All pregnant patients with a proven DVT must be referred to the haematology clinic, not the anticoagulation clinic. All pregnant patients should be treated with LMWH. The weight used for dosing LMWH is the patient’s booking clinic weight. Pregnant women should not administer LMWH into their abdominal wall, they should use their thigh. Cancer (Also add in NICE guidance) People with active cancer and confirmed proximal DVT should be offered anticoagulation therapy (NICE QS29:7). All patients with a known cancer who are having active cancer treatment should be treated with LMWH and continue for 6 months. The patient’s oncologist will be informed if the diagnosis is not made by the oncology service. Arrangements will be made for the platelet count to be monitored. At 6 months the risks and benefits of anticoagulation should be assessed. Treatment where anticoagulation not eligible Patients with proximal DVT or PE should temporarily be offered inferior vena caval filters if they cannot have anticoagulation treatment, and the inferior vena caval filter removed when the patient becomes eligible for anticoagulation treatment. For patients with recurrent proximal DVT or PE health professionals should consider inferior vena caval filters despite adequate anticoagulation treatment only after deliberating alternative treatments such as: Increasing target INR to 3–4 for long-term high-intensity oral anticoagulant therapy or Switching treatment to LMWH. Health professionals should ensure that a strategy for removing the inferior vena caval filter at the earliest possible opportunity is planned and documented when the filter is placed, and that the strategy is reviewed regularly. 2. Medical review Medical input will be needed to: To review and plan investigations for patients with an unprovoked DVT. Review difficult cases where the diagnosis remains in doubt. Define the length of anticoagulation. Review patients where a DVT has been excluded but where an alternative diagnosis remains in doubt. Plan thrombophilia screens where appropriate (see thrombophilia testing section page 14). Page 15 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate 3. Stockings All patients with a proven DVT must wear support stockings for a minimum of 2 years. All below knee DVTs should have Class 2 below knee elastic stockings for 2 years. Above knee DVTs with thigh swelling should have Class 2 full leg elastic stockings for 2 months in the first instance, followed by Class 2 below knee elastic stockings. People with proximal deep vein thrombosis are offered below-knee graduated compression stockings within 3 weeks of diagnosis (NICE QS29:4). Secondary care should provide the initial class 2 stocking with GP’s providing subsequent stockings. Offer below-knee graduated compression stockings with an ankle pressure greater than 23 mmHg to patients with proximal DVT a week after diagnosis or when swelling is reduced sufficiently and if there are no contraindications[3], and: Advise patients to continue wearing the stockings for at least 2 years Ensure that the stockings are replaced two or three times per year or according to the manufacturers' instructions. Advise patients that the stockings need to be worn only on the affected leg or legs. (NICE CG 144) Thrombolysis For patients with an extensive ileo-femoral DVT there is a risk of vascular compromise to the leg. Such cases should be discussed a matter of urgency with a vascular surgeon. Patients without cancer who receive anticoagulation therapy should have a review within 3 months of diagnosis of confirmed DVT to discuss the risks and benefits of continuing anticoagulation therapy (NICE QS29:8). Patients with cancer who receive anticoagulation therapy should have a review within 6 months of diagnosis of confirmed DVT to discuss the risks and benefits of continuing anticoagulation therapy (NICE QS29:9). Consider catheter-directed thrombolytic therapy for patients with symptomatic iliofemoral DVT who have: symptoms of less than 14 days' duration and good functional status and a life expectancy of 1 year or more and a low risk of bleeding. (NICE CG144) Thrombophilia testing Do not offer thrombophilia testing to patients who are continuing anticoagulation treatment. Consider testing for antiphospholipid antibodies in patients who have had unprovoked DVT or PE if it is planned to stop anticoagulation treatment. Page 16 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Consider testing for hereditary thrombophilia in patients who have had unprovoked DVT or PE and who have a first-degree relative who has had DVT or PE if it is planned to stop anticoagulation treatment. Do not offer thrombophilia testing to patients who have had provoked DVT or PE. (NICE QS29:6) Do not routinely offer thrombophilia testing to first-degree relatives of people with a history of DVT or PE and thrombophilia. Explaining the DVT It is the responsibility of the Hospital DVT/VTE Service to try to determine the possible cause of the patients DVT and to conclude if the DVT was provoked or unprovoked. The NICE guidance definition of a provoked DVT or PE is a patient with an antecedent (within 3 months) and transient major clinical risk factor for VTE – for example surgery, trauma, significant immobility (bedbound, unable to walk unaided or likely to spend a substantial proportion of the day in bed or in a chair), pregnancy or puerperium – or in a patient who is having hormonal therapy (oral contraceptive or hormone replacement therapy). Unprovoked is defined as DVT in a person with no antecedent major clinical risk for VTE who is not having hormonal therapy (oral contraceptive or hormone replacement therapy). It is important to identify whether there are any reversible risk factors. The length of time that a patient needs to take anticoagulation will depend whether such risk factors can be removed regardless of whether they are in the time period that is defined as a provoked DVT or PE of three months as defined by NICE. For example there is a fivefold risk of DVT even after five years on an oral contraceptive pill (see table 6 of http://www.bmj.com/highwire/filestream/384759/field_highwire_article_pdf/0/bmj.b2921). When such a risk factor is present, the patient needs only be on anticoagulation for a limited time after the risk factor has been removed. People with active cancer or a family history of VTE should also be considered as having an unprovoked episode because these underlying risks will remain unchanged in the person. However, people with active cancer are not included in this statement. The following could be considered as provocation factors: Oral contraceptive pill Hormone replacement therapy Recent travel on aero plane greater than 4 hours Recent prolonged travel by coach or car Previous PE Known Thrombophilia SLE or other connective tissue disease Myeloproliferative disorder Prothrombotic drugs Page 17 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Proven DVT (d1) DVT unexplained (d1.1) Pursue further tests to find reason for DVT (e1) DVT explained (d1.2) Return to GP or ward (e2) DVT unexplained (d1.1) An unprovoked DVT is patient with unprovoked DVT who are not already known to have cancer should be offered timely investigations for cancer (NICE QS29:5). Investigations for cancer In this context, investigations for cancer refer to investigations in people with unprovoked DVT who are not already known to have cancer to determine if the VTE could be related to a previously undetected cancer. In the context of this pathway, the specific investigations are: A physical examination (guided by the patients full history) Blood tests (full blood count, serum calcium and liver function tests) Urinalysis NICE also suggest the health professional consider further investigations with an abdominopelvic CT scan (and a mammogram for women) in all patients aged over 40 years with a first unprovoked DVT or PE who do not have signs or symptoms of cancer based on the initial investigation (see above paragraph). (NICE CG144). A highly suspected cancer should be urgently referred and seen by a specialist or in a diagnostic clinic within 2 weeks from the date of decision to refer. Investigations should be carried out within 2 weeks of being ordered. Once the patient has been referred for further testing, the patient ends this pathway. The patient should receive any relevant information1 and a copy of the discharge pro-forma – please refer to discharge section. 1 See appendix 5 Page 18 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate DVT explained (d1.2) Patients with provoked DVT should NOT be offered testing for thrombophilia (NICE QS29:6). Patients with a DVT that can be explained should receive all the necessary background and information about their condition (see appendix 5), a treatment plan and anticoagulation review where appropriate. The patients GP should also be informed using the discharge pro-forma found in appendix 4 to help continue to manage the patient in primary care. The patient can then be discharged from the pathway. Once the patient has had their DVT explained, received a treatment plan and all the necessary information, the patient is discharged from this pathway – please refer to discharge section. Recurrent DVT Treatment of recurrent DVT’s are based on clinical judgement and should take in to account provocation, the choice of anticoagulant therapies with patients, and comorbidities and contraindications. Not DVT (d2) Alternative diagnosis (d2.1) (d2.1) GP or return to ward (e2) Referral to continue to pursue alternative diagnosis (e3) Alternative diagnosis (d2.1) The diagnostics may reveal another reason for the symptoms where no DVT is present. NICE guidance stated the following proportion of cases for differential diagnosis for suspected DVT: Muscle Strain, Tear, Twisting Injury Leg Swelling in a Paralysed Limb Lymphangitis or Lymph Obstruction Venous Insufficiency 40% 9% 7% 7% Popliteal (Baker’s) Cyst Cellulitis Knee Abnormality Unknown 5% 3% 25% 26% If an alternative diagnosis can be provided to the patient, all the necessary information about the condition and management of the condition must be provided to the patient. Page 19 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate If an alternative diagnosis was not clearly identified, a likely cause for the symptoms must be provided or the clinician must seek the cause through further tests. Clinicians should not leave the patient with no diagnosis and no explanation for the patient’s symptoms. Patients with no DVT present and referred to pursue alternative diagnosis end this pathway. For patients with an alternative diagnosis and referred back to the GP, please refer to discharge section and then ‘Return to GP (e2)’. Discharge When discharging the patient from the pathway at any point, the patient needs to have been given all the necessary information about what is known about their condition, who they are being referred to, their treatment plan and what the next steps are and what to do if their symptoms change. For those patients receiving anticoagulation therapy for DVT, review may vary dependent on diagnosis but most patients should aim to have a review by at least 3 months (see Review Appointments). Where the initial review of anticoagulation therapy is carried out should be agreed locally. This could be in either anticoagulation clinics, community teams or by the GP. GP’s and the patient should be notified who will carry this out. Patient information (NICE Guidance CG144) Give patients having anticoagulation treatment verbal and written information about: How to use anticoagulants Duration of anticoagulation treatment Possible side effects of anticoagulant treatment and what to do if these occur The effects of other medications, foods and alcohol on oral anticoagulation treatment Monitoring their anticoagulant treatment How anticoagulants may affect their dental treatment Taking anticoagulants if they are planning pregnancy or become pregnant How anticoagulants may affect activities such as sports and travel When and how to seek medical help. Provide patients who are having anticoagulation treatment with an 'anticoagulant information booklet' and an 'anticoagulant alert card' and advise them to carry the 'anticoagulant alert card' at all times. This includes an alert card for Rivaroxaban. Clinicians should ensure a supply is available. Page 20 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Be aware that heparins are of animal origin and this may be of concern to some patients (see Religion or belief: a practical guide for the NHS). For patients who have concerns about using animal products, consider offering synthetic alternatives based on clinical judgment after discussing their suitability, advantages and disadvantages with the patient. [This recommendation is from ‘Venous thromboembolism: reducing the risk’ (NICE clinical guideline 92]). Advise patients about the correct application and use of below-knee graduated compression stockings, how long they should be worn and when they should be replaced. Presenting with signs and symptoms of both DVT and PE If a patient presents with signs or symptoms of both DVT (for example a swollen and/or painful leg) and PE (for example chest pain, shortness of breath or hemoptysis), carry out initial diagnostic investigations for either DVT or PE, basing the choice of diagnostic investigations on clinical judgment. For the management of PE refer to NICE clinical guideline 144 ‘Venous thromboembolic diseases: the management of venous thromboembolic diseases and the role of thrombophilia testing’. Review Appointments For patients with a proven DVT a review is recommended within 3 months to look at; Anticoagulation Suspected Malignancy (though should suspicion occur at diagnosis referral for further testing should happen immediately) Provocation Therapeutic Range and Any adverse events Review appointments could be carried out either at outpatient clinics or by GP’s. The local service should determine this. Patients with lower limb arterial ischemia Patients with lower limb arterial ischemia should be referred to the nearest vascular clinic to be seen by a vascular specialist. Page 21 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate DVT unexplained (d1.1) DVT explained (d1.2) Pursue further tests to find reason for DVT (e1) Alternative diagnosis (d2.1) Return to GP or ward (e2) Referral to continue to (d2.1) pursue alternative diagnosis (e3) Return to GP or ward (e2) Ward clinicians Patients returning to an inpatient ward should have a DVT discharge pro-forma (appendix 4) that outlines diagnosis, medication/treatment, if any further investigations are required and any additional information. If the patient has a DVT and receiving medication, it is necessary for the ward clinician overseeing the patients care establish who will review the treatment/medication which could be determined by the length of time the patient may remain in hospital; and when this should be. And to ensure the clinician reviewing the patient has all the necessary information about the patient’s condition. GP’s Patients discharged from Hospital DVT Team GP’s should be sent a copy of the patients discharge pro-forma once seen and discharged by the Hospital DVT Team. The patient should also have a copy. Patients will then fall in to one of three categories: No DVT No DVT – seek alternative (e3) DVT DVT explained DVT unexplained No DVT No DVT – seek alternative diagnosis (e3) Patients found not to have a DVT may have already been provided with an alternative diagnosis and treatment plan. Where this is not the case, the GP should seek the reason for the abnormally painful or swollen leg(s). Page 22 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate The pathway ends for patients with no DVT present DVT DVT explained This group of patients will have had an explanation as to what most likely caused their DVT by the Hospital DVT team. They will now require a review of their treatment. DVT unexplained Patients found to have a DVT but the reasons were unexplained. The Hospital DVT team may have already referred the patient for further tests. If this has not happened, the GP may wish to pursue further tests to find the reason for DVT. Patients will require review of their treatment. Pursue further tests to find reason for DVT (e1) Return to GP or ward (e2) Referral to continue to pursue alternative diagnosis (e3) Review of treatment where necessary (f1) Review of treatment where necessary (f1) Patients who have a DVT investigated by the Hospital DVT Team should have received their initial treatment and plan on discharge. This will include: Anticoagulation therapy (either Rivaroxaban or Warfarin) Class 2 stockings Discharge pro-forma Referrals where necessary to other specialists Information about their condition Advice and Information about their treatment (including alert cards) Anticoagulation Where the initial review of anticoagulation therapy is carried out should be agreed locally. This could be in either anticoagulation clinics, community teams or by the GP. GP’s and the patient should be notified who will carry this out. Rivaroxaban should be considered as an option for treating DVT first line where felt clinically appropriate and if the patient agrees; Warfarin should also be considered. Both should initially be prescribed by the secondary care team. In the case of Rivaroxaban – secondary care will provide the initial 21 day therapy at recommended dose. Page 23 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate GP Responsibilities for patients continuing on anticoagulation Monitoring the patient’s overall health and well-being and observing patient for evidence of ADRs/abnormalities and raising with secondary care clinician if necessary. Clinical surveillance in line with anticoagulation practice throughout the treatment period Assessment of renal function at least once a year, or more frequently as clinical circumstances dictate when it is suspected that renal function could decline or deteriorate. Annual review as appropriate to include: History of any venous thromboembolic event in last year Reassessment of bleeding risk Prescription of drug after initiation by secondary care Ensuring advice is sought from the secondary care clinician if there is any significant change in the patient’s physical health status Reducing/stopping treatment in line with secondary care clinician’s original request Check patient continues to carry alert card after provision from hospital and supply replacement where necessary. Provide any information or advice where not previously provided Please refer to prescribing guidelines on page 11 Class 2 Stockings All patients with a proven DVT must wear support stockings for a minimum of 2 years. All below knee DVTs should have Class 2 below knee elastic stockings for 2 years. Above knee DVTs with thigh swelling should have Class 2 full leg elastic stockings for 2 months in the first instance, followed by Class 2 below knee elastic stockings. People with proximal deep vein thrombosis are offered below-knee graduated compression stockings within 3 weeks of diagnosis (NICE QS29:4). Offer below-knee graduated compression stockings with an ankle pressure greater than 23 mmHg to patients with proximal DVT a week after diagnosis or when swelling is reduced sufficiently and if there are no contraindications[3], and: Advise patients to continue wearing the stockings for at least 2 years Ensure that the stockings are replaced two or three times per year or according to the manufacturers' instructions. Advise patients that the stockings need to be worn only on the affected leg or legs. (NICE CG 144) Secondary care should provide the initial class 2 stocking with GP’s providing subsequent stockings. Page 24 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Appendix 1: Two-level DVT Wells Score Clinical feature Points Active cancer (treatment on-going, within 6 months, or palliative) 1 Paralysis, paresis or recent plaster immobilisation of the lower extremities 1 Recently bedridden for 3 days or more or major surgery within 12 weeks requiring general or regional anaesthesia Localised tenderness along the distribution of the deep venous system 1 Entire leg swollen 1 Calf swelling at least 3 cm larger than asymptomatic side 1 Pitting oedema confined to the symptomatic leg 1 Collateral superficial veins (non-varicose) 1 Previously documented DVT 1 An alternative diagnosis is at least as likely as DVT -2 1 Clinical probability simplified score Page 25 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Appendix 2 Referral for the diagnosis, investigation and management of abnormally swollen or painful leg(s) Patient Details NHS No: Male / Female (Please Circle) First Name: Surname: Title: DOB: Address: Contact Number: Referral Date: GP Referrer GP Name: GP Surgery: GP Contact Tel. No.: Other Referrer (if not GP) Name: Organisation: Contact Tel. No.: Clinical Details Clinical description: Date of onset of Symptoms: Other Symptoms as relevant: Page 26 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Two-level DVT Wells Score Score Please circle where appropriate Active Cancer (treatment ongoing, within 6 months, or palliative care) Paralysis, paresis, or recent plaster immobilisation of the lower extremities Recently bedridden ≥3 days or major surgery within 12 weeks requiring general or regional anaesthesia Localised tenderness along the distribution of the deep venous system Entire leg swollen Calf swelling 3 cm large than asymptomatic side Pitting oedema confined to the symptomatic leg Collateral superficial veins (non-varicose) Previously documented DVT Alternative diagnosis at least as likely as DVT 1 1 1 1 1 1 1 1 1 −2 Total score D-Dimer Has a D-dimer been carried out? If Yes, What was the result? Yes Positive No Negative Past Medical History: Current Medication: Drug Allergies: Name of referrer: Referrer Signature: Please Fax Referral to Hospital DVT/VTE Service AND telephone to confirm receipt of referral: Hospital DVT/VTE Service <Address of local service> Fax No.: 0161 <fax> Telephone No.: 0161 <phone> Page 27 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Appendix 3: ALGORITHM FOR INVESTIGATING A SUSPECTED DVT IN A SWOLLEN AND/OR PAINFUL LEG Patient with Swollen or Painful Leg NO DVT Considered as a Potential Diagnosis Alternative and Appropriate Care INITIAL CLINICAL ASSESSMENT Well’s score >=2 Wells score <2 D-dimer +ve D-dimer -ve D-dimer -ve Low Risk High Risk Interim Dose of Anticoagulant if Wait for Ultrasound Scan Greater than 4 Hours US D-dimer +ve Interim Dose of Anticoagulant if Wait for Ultrasound Scan Greater than 4 Hours US -ve US -ve +ve Interim Dose of Anticoagulant if Wait for Ultrasound Scan Greater than 4 Hours US +ve NOT DVT US -ve Alternative and Appropriate Care PROVEN DVT Ap Treat With Anticoagualnts Assess for Cause of DVT Page 28 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Appendix 4: DISCHARGE PROFORMA / LETTER Diagnosis, investigation and management of abnormally swollen or painful leg(s) Discharged by Discharging clinician: Title (Dr/ANP): Name: Hospital DVT Service From: <address> Telephone: Fax: Email: Discharge date: Date of dictation: Clinic date: Discharged/Referred to GP Other Specialist within same organisation Other provider team\specialist outside organisation Name: Address: Post Code: Patient details Full Name: NHS Number: Date of birth: Address: Post Code: Discharge destination: Hospital Number: Usual place of residence Hospital ward/unit Other hospital Other Other/Other hospital please state: Page 29 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate GP details GP Name: Address: Postcode: Diagnosis, treatment and management Presenting complaint: Co-morbidities or conditions: Examinations carried out (results to be sent to GP): Physical examination Two level Wells score Baseline blood tests (including D-dimer, U&E, full blood count and clotting profile) Proximal leg ultrasound CT Scan Thrombophilia testing Medical history Other risk factors Full leg length ultrasound Calf vein ultrasound Venogram Other(s) If ‘Other(s)’, please state: Results: Diagnosis: DVT Proven DVT If DVT; Above knee Provoked Recurrent Not DVT Below knee Unprovoked Old Clot Reason Provoked: Reason Unprovoked: Was DVT the reason for symptoms? Yes No Page 30 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Please note: If the patient has not been previously considered at high risk of cardio-vascular disease, this diagnosis of a DVT should lead to a re-assessment. Not DVT Working diagnosis: Definitive diagnosis: Stockings provided? Target INR: Yes No Medication and treatment plan (including planned duration): Follow up or further investigations required? GP Action (as required) / additional information: Patient information sheet: (Please make sure this sheet contains info as to when to seek further help and from whom) (Please Tick (√) to confirm this has been given) Signed: Referrals/copies sent: (Please tick box to confirm copies of this discharge OR referrals have been sent to the following: The patient (as detailed above) Anticoagulation therapy service referral Additional Information on page 4? Other Additional Information to be completed on next page (page 4). Page 31 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Additional information Page 32 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Appendix 5: Patient Information Deep Vein Thrombosis What is a deep vein thrombosis? A DVT is a blood clot that forms in a deep leg vein. Veins are blood vessels that take blood towards the heart. Deep leg veins are the larger veins that go through the muscles of the calf and thighs. (They are not the veins that you can see just below the skin.) When you have a DVT the blood flow in the vein is partially or completely blocked, depending on whether the blood clot partially or completely fills the width of the vein. A calf vein is the common site for a DVT. A thigh vein is less commonly affected. Rarely, other deep veins in the body form blood clots. Why do blood clots form in leg veins? Blood normally flows quickly through veins, and does not usually clot. Blood flow in leg veins is helped along by leg movements, because muscle action squeezes the veins. Sometimes a DVT occurs for no apparent reason. However, the following increase your risk of having a DVT: Immobility which causes blood flow in the veins to be slow. Slow-flowing blood is more likely to clot than normal-flowing blood. o A surgical operation that lasts more than 30 minutes is the most common cause of a DVT. The legs become still when you are under anaesthetic. Blood flow in the leg veins can become very slow. o Any illness or injury that causes immobility increases the risk. o Long journeys by plane, train, etc may cause a slightly increased risk. Damage to the inside lining of the vein increases the risk of a blood clot forming. For example, a DVT may damage the lining of the vein. So, if you have a DVT, then Page 33 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate you have an increased risk of having another one in the future. Some conditions such as vasculitis (inflammation of the vein wall) and some drugs (for example, some chemotherapy drugs) can damage the vein and increase the risk of having a DVT. Conditions that cause the blood to clot more easily than normal (thrombophilia) can increase the risk. Some conditions can cause the blood to clot more easily than usual. For example, nephrotic syndrome and antiphospholipid syndrome. Some rare inherited conditions can also cause the blood to clot more easily than normal. For example, factor V Leiden. The contraceptive pill and hormone replacement therapy (HRT) that contain oestrogen can cause the blood to clot slightly more easily. Women taking 'the pill' or 'HRT' have a small increased risk of DVT. People with cancer or heart failure have an increased risk. Older people are more likely to have a DVT, particularly if you have poor mobility or have a serious illness such as cancer. Pregnancy increases the risk. About 1 in 1,000 pregnant women have a DVT while they are pregnant, or within about six months after they give birth. Obesity also increases the risk. Being male. Men tend to develop a DVT more often than women. Intravenous drug abusers also have an increased risk, particularly if they inject drugs into the veins in their leg or groin areas. How common is a deep vein thrombosis? It is estimated that about 1 in 1000 people have a DVT each year in the UK. Is a deep vein thrombosis serious? It can be. When a blood clot forms in a leg vein it usually remains stuck to the vein wall. The symptoms tend to settle gradually. However, there are two main possible complications: Pulmonary embolus (a blood clot that travels to the lung). Post thrombotic syndrome (persistent calf symptoms). Pulmonary embolus In a small number of people who have a DVT, a part of the blood clot breaks off. This travels in the bloodstream and is called an embolus. An embolus will travel in the bloodstream until it becomes stuck. An embolus that comes from a clot in a leg vein will be carried up the larger leg and body veins to the heart, through the large heart chambers, but will get stuck in a blood vessel going to a lung. This is called a pulmonary embolus. DVT and pulmonary embolisms are known collectively as venous thromboembolisms. A small pulmonary embolus may not cause any symptoms. A medium sized pulmonary embolus can cause breathing problems and chest pain. A large pulmonary embolus can cause collapse and sudden death. It is estimated that about 1 in 10 people with an untreated DVT develop a pulmonary embolus large enough to cause symptoms or death. Post-thrombotic syndrome Without treatment, up to 6 in 10 people who have a DVT develop long-term symptoms in the calf. This is called 'post-thrombotic syndrome'. Symptoms occur because the increased flow and pressure of the diverted blood into other veins can affect the tissues of the calf. Page 34 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Symptoms can range from mild to severe and include: calf pain, discomfort, swelling, and rashes. An ulcer on the skin of the calf may develop in severe cases. Post-thrombotic syndrome is more likely to occur if the DVT occurs in a thigh vein, or extends up into a thigh vein from a calf vein. It is also more common in people who are overweight, and in those who have had more than one DVT in the same leg. What are the aims of treatment for a deep vein thrombosis? The aims of treatment are: To prevent the clot spreading up the vein and getting larger. This may prevent a large embolus breaking off and travelling to the lungs (a pulmonary embolus). To reduce the risk of post-thrombotic syndrome developing. To reduce the risk of a further DVT in the future. What are the treatments for a deep vein thrombosis? Anticoagulation - preventing the clot from getting larger Anticoagulation is often called 'thinning the blood'. However, it does not actually thin the blood. It alters certain chemicals in the blood to stop clots forming so easily. This prevents a DVT from getting larger, and prevents any new clots from forming. Rivaroxaban should be considered where appropriate as a first line treatment for DVT; Warfarin is also a treatment. However, it takes a few days for Warfarin tablets to work fully. Therefore, heparin injections are used alongside Warfarin in the first few days for immediate effect. A serious embolus is rare if you start anticoagulation treatment early after a DVT. The aim is to get the dose just right so the blood will not clot easily, but not too much, which may cause bleeding problems. You will need regular blood tests whilst you take Warfarin. You need them quite often at first, but then less frequently once the correct dose is found. (If you are pregnant, regular heparin injections rather than Warfarin tablets may be used.) The length of time you will be advised to take anticoagulation depends on various factors. For example, if you have a DVT during pregnancy or after an operation, then after the birth, or when you are fit again, the increased risk is much reduced. So, anticoagulation may be only for a few months. On the other hand, some people continue to have an increased risk of having a DVT. In this case the anticoagulation may be long-term. Note: you should not travel on any long journeys or travel by plane until at least two weeks after starting anticoagulant treatment. Travel within two weeks of a DVT is not recommended without seeking advice from a specialist. Compression stockings Most people who develop a DVT are advised to wear compression stockings. This treatment has been shown to reduce the risk of a recurrent DVT, and can also reduce the risk of developing post-thrombotic syndrome. You should wear the stocking each day, for at least two years. If you do develop post-thrombotic syndrome, you may be advised to wear the stockings for more than two years. Note: a compression stocking used following a DVT should be fitted professionally after an Page 35 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate assessment and accurate measurement. Do not just buy 'over the counter' support stockings that may be the wrong class or size and which may potentially cause more damage. Your stockings will also need changing every 3-6 months. If you are advised to wear a compression stocking, you should put it on each day whilst lying in bed before getting up. Wear it all day until you go to bed, or until you rest in the evening with the leg raised. Take the stocking off before going to bed. The slight pressure from the stocking helps to prevent fluid seeping into the calf tissues from the outer veins which carry the extra diverted blood following a DVT. The stocking also reduces, and may prevent, calf swelling. This in turn reduces discomfort and the risk of skin ulcers forming. Walking regularly but raising your leg whilst resting Unless your doctor advises against this, you should walk regularly. Walking is thought to improve circulation in the affected leg and may help to reduce your risk of further DVT. When you are resting, as much as possible - raise your leg. This reduces the pressure in the calf veins, and helps to prevent blood and fluid from 'pooling' in the calves. 'Raised' means that your foot is higher than your hip so gravity helps with blood flow returning from the calf. The easiest way to raise your leg is to recline on a sofa with your leg up on a cushion. Raise the foot of the bed a few inches if it is comfortable to sleep like this. This is so your foot and calf are slightly higher than your hip when you are asleep. Ways to reduce the risk of recurrent DVT after treatment has stopped. Things that may help to prevent a recurrent DVT include the following: If possible, avoid long periods of immobility, such as sitting in a chair for many hours. If you are able to, get up and walk around now and then. A daily brisk walk for 30-60 minutes is even better if you can do this. The aim is to stop the blood 'pooling', and to get the circulation in the legs moving. Regular exercise of the calf muscles also helps. You can do some calf exercises even when you are sitting. Major operations are a risk for a DVT - particularly operations to the hip, lower abdomen, and leg. You may be given an anticoagulant such as a heparin injection just before an operation to help prevent a DVT. An inflatable sleeve connected to a pump to compress the legs during a long operation may also be used. You may also be given compression stockings to wear whilst you are in hospital. It is also common practice to get you up and walking as soon as possible after an operation. When you travel on long plane journeys, train journeys etc. you should have little walks up and down the aisle every now and then. Also, exercise your calf muscles every now and then whilst sitting in your seat. If you have had a previous DVT, you should see your doctor for advice before you travel on a long journey or fly. People who are overweight have an increased risk of DVT. Therefore, to reduce your risk, you should try to lose weight. In summary The main cause of DVT is immobility - especially during surgery. The most serious complication of DVT is a pulmonary embolus where part of the blood clot breaks off and travels to the lung. Persistent calf symptoms may occur after a DVT. Page 36 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate With treatment, the risk of the above two complications is much reduced. Treatment includes anticoagulation, compression stockings, leg elevation, and keeping active. Prevention is important if you have an increased risk of DVT. For example, during long operations or when you travel on long journeys. References Deep vein thrombosis, Clinical Knowledge Summaries (April 2009) Keeling DM, Mackie IJ, Moody A, et al; The diagnosis of deep vein thrombosis in symptomatic outpatients and the potential for clinical assessment and D-dimer assays to reduce the need for diagnostic imaging. Br J Haematol. 2004 Jan;124(1):15-25. Venous thromboembolism: reducing the risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in inpatients undergoing surgery, NICE Clinical Guideline (2007) Page 37 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Advice to patients about POST-THROMBOTIC SYNDROME What is Post-Thrombotic Syndrome? Post-thrombotic syndrome (PTS) is the name used to describe the long-term effects that can occur after you have had a venous thrombosis of the deep veins of the leg (DVT). Generally, 1 out of 3 people who have had thrombosis in the legs will develop some post-thrombotic symptoms within 5 years. Most symptoms of postthrombotic syndrome will occur within 2 years of the thrombosis. People who have thrombosis more than once (recurrent thrombosis) are at higher risk of developing post-thrombotic syndrome. Thrombosis can go unnoticed, so it is sometimes possible to have post-thrombotic syndrome without being diagnosed with thrombosis first. What is the problem? When you have a DVT it interferes with the blood flow returning from the leg back to the heart. This is why many people with a DVT complain of pain and swelling of the lower leg at the time. The blockage in the deep veins often disappears with anticoagulation treatment and time but sometimes it remains. The DVT can also damage the valves in the veins which normally stop blood flowing backwards down the leg. Blocked veins and/or damaged valves means that it is more difficult for blood to be pumped out of your leg efficiently when you walk. The accumulation of blood at a higher pressure than normal causes the symptoms of PTS. How do I know if I have Post-Thrombotic Syndrome? PTS can result in heaviness and swelling of the leg. This heaviness and swelling is usually worse after prolonged sitting or standing and is helped by walking. However, sometimes the symptoms are made worse by exercise if the obstruction to blood flow out of the leg is very severe. PTS can also cause redness and pain of the skin around the ankle (inflammation) and swelling due to leakage of fluid (oedema). If untreated, this skin damage can result in ulceration. How does PTS differ from a DVT? Anyone who has had a DVT has an increased risk of another one. However, the degree of this risk depends upon the cause of the original DVT and usually diminishes with time. It is important to report any sudden changes in the affected leg so your doctor can exclude a new DVT. This may be difficult to distinguish from PTS and an ultrasound of the leg is usually necessary. This is a painless test that looks at the veins and the blood flow in your leg using high frequency sound waves. Page 38 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate What can I do about it? Although PTS cannot be cured it is usually possible to control the symptoms and reduce the risk of ulceration. Compression Stockings To help minimise development of PTS, it is best, unless contra indicated, to wear a compression stocking as soon as a DVT is diagnosed. It is only normally needed on the affected leg. These stockings should be prescribed by your General Practitioner and measured accurately by the Pharmacists so they fit correctly. You should put on the stocking before you get out of bed and only remove it before going to bed. Below knee stockings are usually sufficient except when the venous damage is very extensive. Compression stockings are available in 3 strengths: Class 1, 2 and 3.Your GP will decide what strength you need but Class 2 is usually sufficient to control the swelling. Open toe stockings can be worn under socks or tights. Closed toe stockings can be worn by themselves like popsocks, and are cooler in hot weather. There are many different makes of compression stocking – if one kind doesn’t suit you, try another. You may also find it useful to buy an applicator specially designed to help you apply the stockings. You will need a new supply of stockings every 4 – 6 months. Stockings should be worn for a minimum of 2 years after a DVT. Other things that help There are other things which you can do to reduce the symptoms of PTS: Eat a healthy balanced diet with plenty of fresh fruit and vegetables. Try to lose weight if you are overweight as increased weight puts more strain on the veins. Exercise regularly as this assists the calf muscle to pump blood up the veins. If you are unable to walk, try moving your feet up and down while you are sitting or lying. Consider an exercise bike or aqua aerobics at your local swimming pool. When sitting, elevate your leg on another chair or on the end of the sofa. Stop smoking as this reduces the amount of oxygen to your legs Wear correctly fitting shoes with a low heel, and elevate you legs whenever possible. Wash and cream your legs regularly to avoid dry skin which is more easily damaged. Seek immediate medical or nursing advice if you damage your skin. Never try to heal the wound yourself. With thanks to the Sheffield Vascular Institute - Sheffield Teaching Hospitals NHS Foundation Trust website (http://www.sth.nhs.uk ) Page 39 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Rivaroxaban patient information You have been prescribed rivaroxaban as you have been diagnosed with a deep vein thrombosis (DVT). Rivaroxaban works by preventing your blood from clotting as quickly or as effectively as normal. It does this by blocking a substance in your blood which is involved in the development of blood clots, called factor Xa. Sometimes harmful blood clots can form in the veins of your legs and cause a blockage. People who take rivaroxaban do not need to have regular blood tests. Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking rivaroxaban it is important that your doctor or pharmacist knows: If you are pregnant or breast-feeding. If you have had any surgery recently (other than hip or knee surgery). If you have an ulcer in your stomach or intestines, or if you have recently recovered from one. If you have high blood pressure. If you have any medical problems that may increase your risk of bleeding. If you have a problem with the blood vessels in your eyes, known as vascular retinopathy. If you have any problems with your liver or kidneys. If you are taking or using any other medicines. This includes any medicines you are taking which are available to buy without a prescription, such as herbal and complementary medicines. If you have ever had an allergic reaction to any medicine. How to take rivaroxaban Before you start this treatment, read the manufacturer's printed information leaflet from inside your pack. The leaflet will give you more information about rivaroxaban, and a full list of possible side-effects from taking it. Take rivaroxaban exactly as your doctor has told you. The usual dose is 15mg twice daily for 3 weeks then 20 mg daily for duration of therapy. You should take rivaroxaban after a meal. This is because food may interfere with the amount of rivaroxaban your body absorbs. Try to take rivaroxaban at the same time each day, as this will help you to remember to take it. If you forget to take a dose, take it as soon as you remember. If you do not remember until the following day, skip the missed dose. Do not take two doses together to make up for a forgotten dose. If you take any medicines that you have bought without a prescription, check with a pharmacist that they are suitable to take with rivaroxaban. This is because some medicines, such as some painkillers, may interfere with it. If you are having an operation or dental treatment, tell the person carrying out the treatment which medicines you are taking. Page 40 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Can rivaroxaban cause problems? Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. These usually improve as your body adjusts to the new medicine, but speak with your doctor f any of the following side-effects continue or become troublesome. Common rivaroxaban side-effects these affect less than 1 in 10 people who take this medicine What can I do if I experience this? Feeling sick If you are not already doing so, try taking your doses after a meal Bleeding (such as nosebleeds), anaemia if you experience any unusual bleeding, speak with your doctor immediately or go to your local accident and emergency department without delay. Feeling dizzy or faint If this happens, do not drive or use tools or machines until you feel well again Changes in some blood tests, fever, swollen feet or ankles, rash If you are concerned about any of these, speak with your doctor Important: If you experience any other symptoms which you think may be due to this medicine, speak with your doctor or pharmacist. How to store rivaroxaban Keep all medicines out of the reach and sight of children. Store in a cool, dry place, away from direct heat and light. Manufacturer's PIL, Xarelto® 15 mg & 20 mg film-coated tablets; Manufacturer's PIL, Xarelto® 15 mg & 20 mg film-coated tablets, Bayer plc, The electronic Medicines Compendium. Dated December 2011. View this article online at www.patient.co.uk/medicine/Rivaroxaban-to-prevent-bloodclots.htm Page 41 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate WARFARIN ANTICOAGULANT FACT SHEET Most patients are prescribed Warfarin for anticoagulation. You will be given an anticoagulant record book. The book tells you exactly how much Warfarin you need to take and the date of your next appointment. An alert card is provided to put inside your purse or wallet. It contains important information that other health professionals may need to know. Why have I been prescribed Warfarin? Warfarin is used to prevent blood clots forming or growing bigger. It is commonly prescribed for patients when clots have already developed e.g. Deep vein thrombosis. It prevents the clot growing bigger and reduces the risk of part of the clot breaking off and moving around the blood stream to cause further problems. Warfarin interferes with the body’s normal clotting system so that your blood takes longer to clot than usual thereby reducing the risk of clots developing. How do I take Warfarin? Warfarin comes in 3 strengths 1mgs Brown tablet 3mgs Blue tablet 5mgs Pink tablet The prescribed dose should be taken every day, preferably in the evening If you go to bed and forget – do not double your dose. Simply take your normal dose at the normal time next day and make a note in your Yellow book of the date you missed your dose. Why do I need to have blood tests? Warfarin has an unpredictable individual response. Some patients need ½ mg daily while others need up to 20mgs to get the same response. Levels need to be monitored on a regular basis as Warfarin is affected by many internal and external influences e.g. Food and drink Illness Stress Exercise Medications (including herbal preparations) Alcohol The range is the level your blood clotting ideally should be stabilized at. It is usually 2-3. A normal clotting time is 1.0. Below 2.0 and the risk of clot formation is higher; above 3.0 and the risk of bleeding problems is higher What are the side effects of Anticoagulant therapy? Very few people experience side effects from oral anticoagulant drugs. The main risk is bleeding. Possible bleeding signs are Nosebleeds Page 42 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Red or dark urine Unexplained bruising Black or tarry bowel motion Gums bleeding Vaginal bleeding Any unexpected bleeding should be reported immediately to your GP. Other less common side effects are: Hypersensitivity Rash Hair loss Purple toes It is important that you contact your Anticoagulant clinic or GP if you think you may be experiencing side effects from the Warfarin other than bleeding. Are there any other things I need to know? Inform your Anticoagulant clinic immediately if other tablets change – particularly antibiotics or painkillers. Avoid Aspirin unless specifically prescribed by a Doctor. Note that Aspirin is found in cold relief preparations so check with the chemist. Many herbal preparations should not be taken with Warfarin. Let us know if you are thinking of trying any such medications. Warfarin is not usually recommended during pregnancy. If you miss a period you must take a pregnancy test as soon as possible and let your Anticoagulant clinic know. It is safe to breastfeed on Warfarin. After a blood test, injection or skin cut you need to apply pressure for a longer time until any bleeding has stopped. Inform the person taking blood that you are on anticoagulants. Avoid contact sports. Seek medical advice if you have a fall or head injury Page 43 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Appendix 6: Prescribing guideline for clinicians and patients choosing rivaroxaban to treat DVT The NICE single technology assessment reviewed and approved rivaroxaban for the treatment of DVT. It is still unclear who will most benefit from rivaroxaban but the following is a guide. Rivaroxaban should be considered in: Patients with a new diagnosis of DVT who after discussion of the risks and benefits opt for rivaroxaban Patients on long-term warfarin who have poor control (time in therapeutic range less than 55%) which is not felt to be due to intentional non-adherence Patients with other medical conditions that require regular introductions of medications which interfere with warfarin, e.g. COPD with antibiotics, and cause the need for very frequent INR monitoring/dose changes. Patients who are currently managed on LMWH because of difficulty in INR monitoring. Patients with poor mobility who find it difficult to attend outpatient clinics and/or require home visits. Rivaroxaban should be used with caution in patients with: Renal disease and impairment e.g. CKD stage 3 and 4 or eGFR <60mls/min Aged more than 75 years Patients who are planned to take anticoagulation indefinitely (more than 12 months) because of the lack of long-term safety data for rivaroxaban. Rivaroxaban should not be used in the following situations: Patients who are already on warfarin and well controlled, and who have not had adverse events. This is due to the lack of long-term safety data in this indication. History of gastrointestinal bleed Pregnancy or lactation Patients with active or recent (<6/12) diagnosis of cancer Patients with known antiphospholipid syndrome Patients with a target INR more than 3.0 Other indications for warfarin, except non-valvular atrial fibrillation * see separate guide for use of NOACs in stroke or non-valvular AF. Patients with known poor compliance, as missing a single dose may leave a patient under-anti-coagulated due to the short half-life of rivaroxaban Patients with eGFR < 30mls/min Rivaroxaban is suggested as an option which should be discussed with the patient in: Patients who have a suspected DVT and are awaiting appropriate imaging. Patients who have had a provoked DVT or first unprovoked DVT in whom a finite period of anticoagulation is required. Full details are available from the SPC Page 44 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate (http://www.medicines.org.uk/EMC/medicine/25586/SPC/Xarelto%2020mg%20filmcoated%20tablets/ ) Guide for new patients starting RIvaroxaban: Check FBC and coagulation screen, if low platelets or abnormal coagulation discuss with haematology. Check U&E – suggest avoiding if GFR less than 30mls/min Start rivaroxaban at 15mg twice daily for 3 weeks then 20mg daily thereafter. Monitor U&E at least every year if baseline normal, every six months if baseline abnormal. No requirement for coagulation monitoring. Patients switching from warfarin to Rivaroxaban Check U&E – suggest avoiding if GFR less than 30mls/min Stop warfarin and monitor INR daily, start rivaroxaban, as above, when INR less than 2.5 Monitor U&E at least every year if baseline normal, every six months if baseline abnormal. No requirement for coagulation monitoring. Patients switching from LMWH to Rivaroxaban Check U&E – suggest avoiding if GFR less than 30mls/min Stop LMWH and start rivaroxaban, as above, between 0-2 hours before next dose would have been due. Monitor U&E at least every year if baseline normal, every six months if baseline abnormal. No requirement for coagulation monitoring. RIVAROXABAN WILL CAUSE PROLONGATION OF THE COAGULATION SCREEN Management of patients having planned operative procedures If at all possible elective procedures should be delayed for as long after the thrombosis as possible. Note the half-life of rivaroxaban is approximately 5-13 hours. The half-life is considerably more in patients with kidney disease CKD 3/ or 4. A normal coagulation profile may indicate that the anticoagulant effect of the drug is no longer significant. Rivaroxaban can usually be restarted the following day when complete haemostasis has been secured but if there is concern over bleeding then re-introduction should be delayed, bridging therapy with LMWH may be required if there is a more than 24 hour delay. An individual risk assessment should be carried out and discussion between the surgical and haematology team and the patients GP. Emergency surgery on rivaroxaban Where patients require emergency surgery a full clotting screen with PT and APTT should be checked. Where results are normal, this suggests that the activity of rivaroxaban has ceased. Page 45 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate For prolonged clotting times, delay the procedure for as long as is safe to allow clearance of the drug. Early discussion with a haematologist is recommended and a bleeding management plan should be documented. Dental procedures on rivaroxaban Rivaroxaban at standard dose is approximately equitant to an INR of 2.5. Therefore dental procedures that previously would have been safely performed whilst on warfarin can be performed without interruption of rivaroxaban. Where possible the dental surgery should be planned for as late in the day as possible to ensure the lowed drug concentration. Patients should be advised to delay the following dose for up to 4 hours. Management of bleeding on rivaroxaban - see local Trust guidelines for management plans Prescribing Responsibilities Rivaroxaban was reviewed by NICE under a technology appraisal (TA261) for the treatment of DVT. The decision from NICE was to recommend rivaroxaban as an option for treating deep vein thrombosis and preventing recurrent deep vein thrombosis and pulmonary embolism after the diagnosis of acute DVT in adults. The main advantage of rivaroxaban over combination therapy with low molecular weight heparin followed by warfarin relates to the lack of monitoring required during treatment. However, there are other factors that should be considered when deciding to treat DVTs with rivaroxaban over warfarin. Rivaroxaban (Xarelto®) is a specific inhibitor of activated factor Xa with high oral bioavailability and a half-life of approximately nine hours. Secondary Care Responsibilities Diagnosis of DVT Ensuring other treatment options have been explored Discussion of risks/ benefits, initiation of treatment Provide initial 21 day therapy at recommended dose Advising GP on monitoring adverse drug reactions (ADRs) Liaison with the general practitioner (GP for continuation of supply) Providing written information to the GP stating the date when therapy should be reduced or stopped assuming no relapse in patient’s condition Responding to issues raised by GP after care of patient has been transferred GP Responsibilities Monitoring the patient’s overall health and well-being and observing patient for evidence of ADRs/abnormalities and raising with secondary care clinician if necessary. Clinical surveillance in line with anticoagulation practice throughout the treatment period Page 46 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Assessment of renal function at least once a year, or more frequently as clinical circumstances dictate when it is suspected that renal function could decline or deteriorate. Annual review as appropriate to include: History of any venous thromboembolic event in last year Reassessment of bleeding risk Prescription of drug after initiation by secondary care Ensuring advice is sought from the secondary care clinician if there is any significant change in the patient’s physical health status Reducing/stopping treatment in line with secondary care clinician’s original request Ensure patient has Yellow anticoagulant book for warfarin or Rivaroxaban alert card if patient has not already had one supplied Patient Responsibilities Report untoward effects to prescribing clinician Compliance with treatment Compliance with blood tests as detailed by prescribing clinician Informing other professionals as appropriate that they are receiving an anticoagulant Prescribing & Clinical Information Summary Summary of Product Characteristics (SPC) Xarelto (Rivaroxaban), Bayer. Available from eMC at http://emc.medicines.org.uk/ BNF prescribing information available at http://bnf.org/bnf/ Page 47 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Appendix 7: Counselling checklist for Warfarin Introduce yourself. Explain the medical condition requiring Anticoagulation. Explain how the drug works .i.e. ‘longer to clot not thinner’. Show the patient the Yellow Anticoagulant booklet and alert card. Tell them to take the book or alert card with them if they leave the house. Explain what the range means and what their desired range is. Tell them the intended duration of therapy. Explain the importance of blood monitoring and about our clinics. Show them the different strengths of tablets. Test the patient on dose adjustments to check understanding of dose changes. Tell the patient when to take the tablets .i.e. roughly same time each evening. Explain what to do if the patient misses a dose; i.e. If a dose is missed, it can still be taken on the day it was missed, otherwise continue the following day as per normal. Do not double up on dose. Advise INR clinic of any missed doses at next appointment. If an extra tablet is taken accidentally, patient to seek medical advice. Explain the signs of under / over dosage. Explain about local pressure after injection, laceration or venepuncture. Explain the risk of bleeding / bruising and what action to take in the event of bleeding, fall or head injury. Seek medical attention if blood in urine, faeces, vomit or sputum, vaginal bleeding (other than regular period), severe unusual headache Explain how to get repeat prescriptions. Tell the patient to inform other health care professionals .e.g. dentists that they are on oral anticoagulants. Explain the risk of potential drug interactions particularly antibiotics and over the counter drugs and to report medication changes to clinic staff immediately. Advise patient to inform us of changes to health lasting more than 4 days .e.g. pain, D&V, flu. Explain about the risk of herbal drug interactions and tell the patient to check safety with clinic staff before purchase. Explain that dietary changes may affect control. No Cranberry products or Aspirin unless agreed by medical staff. Inform the patient of safe alcohol intake limits. If the patient is female and could possibly become pregnant explain the risks and actions to take if a period is missed. Discuss the risk of contact sports if applicable. Ask if the patient has any other questions. I confirm that (counsellor) ________________________ has given me the above verbal information, a fact sheet on oral Anticoagulant therapy and an initial supply of Warfarin. Patient name Signed (patient) NHS No - Date - Page 48 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Counselling checklist for Rivaroxaban Introduce yourself. Explain that Rivaroxaban is being prescribed to treat a DVT and reduce risk of embolism. Explain how the drug works .i.e. ‘blood takes longer to clot not thinner’. Show the patient the information booklet and alert card. Advise the patient to put the alert card in a purse or wallet. Explain the initial intended duration of therapy and review arrangements. Explain the dose to take .i.e. 15mg TWICE daily for 3 weeks then 20mg ONCE daily thereafter. Swallow whole and take with food. Advise the patient of what to do if misses a dose; i.e. If a dose is missed, it can still be taken on the day it was missed, otherwise continue the following day as per normal. Do not double up on dose. If an extra capsule is taken accidentally, advise patient to seek medical advice Advise patient to apply local pressure after injection, laceration or venepuncture. Explain the risk of bleeding / bruising and what action to take in the event of unexpected bleed, fall or head injury. No direct antidote but local procedures in place to deal with bleeding. Explain how to get repeat prescriptions. Advise the patient to inform any health care professionals .e.g. doctors / dentists that they are on Rivaroxaban. Explain the risk of potential side effects / adverse events and to report concerns to GP immediately. Seek medical attention if any blood in urine, faeces, vomit or sputum, vaginal bleeding (other than regular period), severe unusual headache No Aspirin unless agreed by medical staff. If the patient is female and could possibly become pregnant explain the risks and actions to take if a period is missed. Discuss the risk of contact sports if applicable. Ask if the patient has any other questions. I confirm that (counsellor) ________________________ has given me verbal information, a fact sheet and Patient Alert Card for Rivaroxaban. I have been given an initial supply of Rivaroxaban. Patient name Signed (patient) NHS No - Date - Page 49 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Appendix 8: GREATER MANCHESTER GUIDELINE FOR: THE DIAGNOSIS, INVESTIGATION AND MANAGEMENT OF ABNORMALLY SWOLLEN OR PAINFUL LEG(S) GP GUIDE Version: Date: Intended Audience: Authors: Version 2.2 30th April 2014 GP Practices, DVT Steering Group Members of the DVT Steering Group and Daniel Watts (derived from full DVT guideline document) Page 50 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate DVT Pathway at GP level Stage 1 – First presentation (Front End) (a1) Patient presents to GP with abnormally swollen or painful leg(s) Symptoms Physical Examination Medical History Any exclusion criteria Wells score Can GP Practice provide d-dimer testing? Yes (a1a) Perform d-dimer and see baseline tests section No Is there a community DVT service? DVT possible? No (c2) Seek alternative diagnosis (End of pathway) Yes (c1) Refer for Ultrasound and see prescribing LMWH and exclusions Yes (a1b) Refer as appropriate using local guidance (this pathway ends) No (b) Refer to Hospital DVT team using proforma Page 51 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Stage 2 – Treatment (back end of pathway) DVT? Yes (e1/e2/f1) Patients discharged from Hospital DVT Team: Review treatment (see review treatment section) Patients returning from ultrasound: Refer to locally agreed guidelines No (e3) Seek alternative diagnosis* (end of pathway) Patients discharged from community DVT service: Refer to locally agreed guidelines *Seek alternative diagnosis if not already provided. Page 52 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Breakdown of the pathway Stage one: First presentation (front end of pathway) Patient with signs or symptoms of deep vein thrombosis (DVT), such as a swollen or painful leg(s) (a1) Patient presents to GP Check symptoms Physical examination to exclude other causes Patients general medical history Exclusion criteria Two-level DVT Wells Score (appendix 1) At this point a decision is made whether or not a patient should commence on a DVT pathway. The distinction being: any patient with signs or symptoms in a lower limb suggesting DVT as a potential diagnosis. If a DVT is suspected but d-dimer cannot be provided locally – refer to community DVT service (if one available) or hospital DVT service using the referral pro-forma (appendix 2) as appropriate. Where d-dimer can be provided locally – refer to the rest of this section on pages 4 and 5. (a1a) Providing d-dimer locally Review baseline tests to determine if a patient should be sent for an ultrasound or an alternative diagnosis should be sort: Where DVT a possibility High Risk Wells score >=2 Low Risk Wells score <2 plus Where DVT unlikely Wells Score <2 plus Positive d-dimer Negative d-dimer For patients where DVT a possibility – (c1) refer for ultrasound Patients where a DVT is a possibility should be sent for an ultrasound scan as soon as possible. These patients should be offered an interim therapeutic dose of anticoagulation Page 53 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate therapy if diagnostic investigations are expected to take longer than 4 hours from the time of first clinical suspicion. (NICE QS29:1) Prescribing Low Molecular Weight Heparin’s (LMWH) - exclusions There are some patients that may also have relative contraindications and therefore should not routinely be prescribed LMWH. These patients include: Already taking an anticoagulant – in such cases it would be unsafe to give further anticoagulants until a DVT is proven. A proviso to this approach would be in a patient taking an oral anticoagulant but where the INR is sub therapeutic (usually less than 2). Co-morbid diseases which preclude ambulatory management – in such cases a suspected DVT might be present with one or more other active conditions. It is not possible to define all possible scenarios and clinical assessment will be important, for example patients unable to rest and elevate the affected leg at home. Estimated GFR less than 30ml/min – the dose of LMWH will need to be adjusted, however it might be safer to treat such patients as in-patients. Leg Trauma – any history of leg trauma should alert the attending practitioner to the possibility of a muscle tear. In such cases the administration of LMWH could have disastrous consequences. Cannot comply with ambulatory administration LMWH via a District Nurse, daily visit to the Ambulatory Clinic or unable to self-administer. Dual anti-platelet therapy of Aspirin AND Clopidogrel. For all of the relative exclusion criteria the attending health professional ANP will need to weigh-up the risk a DVT against the risk-benefit of LMWH, prior to a Ultrasound scan. Patients need to be informed heparins are of animal origin. If they are concerned about using animal products, the health professional should consider using synthetic alternatives based on clinical judgement and discussing their suitability, advantages and disadvantages. People with suspected deep vein thrombosis have all diagnostic investigations completed within 24 hours of first clinical suspicion (NICE QS29:2). For patients where DVT unlikely – (c2) seek alternative diagnosis Patients where the baseline tests reveal a DVT is unlikely should have arrangements made where an alternative diagnosis is either given or pursued. The only situation which would negate the need for an ultrasound scan is when there is an obvious alternative diagnosis. For patients where a DVT unlikely: end this specific pathway Page 54 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Stage 2: Treatment (back end of pathway) This section refers to those patients returning from the hospital DVT service have had diagnostics to conclude either DVT or no DVT. Patients discharged from Hospital DVT Team (e1/e2/e3/f1) GP’s should be sent a copy of the patients discharge pro-forma once seen and discharged by the Hospital DVT Team. The patient should also have a copy. Patients will then fall in to one of three categories: No DVT No DVT – seek alternative (e3) DVT DVT explained DVT unexplained No DVT No DVT – seek alternative diagnosis (e3) Patients found not to have a DVT may have already been provided with an alternative diagnosis and treatment plan. Where this is not the case, the GP should seek the reason for the abnormally painful or swollen leg(s). The pathway ends for these patients DVT DVT explained (d1.2/e2) This group of patients will have had an explanation as to what most likely caused their DVT by the Hospital DVT team. They will now require a review of their treatment. DVT unexplained (d1.1/e1) Patients found to have a DVT but the reasons were unexplained. The Hospital DVT team may have already referred the patient for further tests. If this has not happened, the GP may wish to pursue further tests to find the reason for DVT. Patients will require review of their treatment. Review of treatment where necessary (f1) Patients who have a DVT investigated by the Hospital DVT Team should have received their initial treatment and plan on discharge. This will include: Anticoagulation therapy (either Rivaroxaban or Warfarin) Class 2 stockings Discharge pro-forma Referrals where necessary to other specialists Page 55 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Information about their condition Advice and Information about their treatment (including alert cards) Anticoagulation Where the initial review of anticoagulation therapy is carried out should be agreed locally. This could be in either anticoagulation clinics, community teams or by the GP. GP’s and the patient should be notified who will carry this out. Rivaroxaban should be considered as an option for treating DVT first line where felt clinically appropriate and if the patient agrees; Warfarin should also be considered. Both should initially be prescribed by the secondary care team. In the case of Rivaroxaban – secondary care will provide the initial 21 day therapy at recommended dose. GP Responsibilities for patients continuing on anticoagulation Monitoring the patient’s overall health and well-being and observing patient for evidence of ADRs/abnormalities and raising with secondary care clinician if necessary. Clinical surveillance in line with anticoagulation practice throughout the treatment period Assessment of renal function at least once a year, or more frequently as clinical circumstances dictate when it is suspected that renal function could decline or deteriorate. Annual review as appropriate to include: History of any venous thromboembolic event in last year Reassessment of bleeding risk Prescription of drug after initiation by secondary care Ensuring advice is sought from the secondary care clinician if there is any significant change in the patient’s physical health status Reducing/stopping treatment in line with secondary care clinician’s original request Check patient continues to carry alert card after provision from hospital and supply replacement where necessary. Provide any information or advice where not previously provided Please refer to prescribing guidelines on page 11 Class 2 Stockings All patients with a proven DVT must wear support stockings for a minimum of 2 years. All below knee DVTs should have Class 2 below knee elastic stockings for 2 years. Above knee DVTs with thigh swelling should have Class 2 full leg elastic stockings for 2 months in the first instance, followed by Class 2 below knee elastic stockings. People with proximal deep vein thrombosis are offered below-knee graduated compression stockings within 3 weeks of diagnosis (NICE QS29:4). Offer below-knee graduated compression stockings with an ankle pressure greater than 23 mmHg to patients with proximal DVT a week after diagnosis or when swelling is reduced sufficiently and if there are no contraindications[3], and: Advise patients to continue wearing the stockings for at least 2 years Page 56 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Ensure that the stockings are replaced two or three times per year or according to the manufacturers' instructions. Advise patients that the stockings need to be worn only on the affected leg or legs. (NICE CG 144) Secondary care should provide the initial class 2 stocking with GP’s providing subsequent stockings. Appendix 1: Two-level DVT Wells Score Clinical feature Points Active cancer (treatment on-going, within 6 months, or palliative) 1 Paralysis, paresis or recent plaster immobilisation of the lower extremities Recently bedridden for 3 days or more or major surgery within 12 weeks requiring general or regional anaesthesia Localised tenderness along the distribution of the deep venous system 1 Entire leg swollen 1 Calf swelling at least 3 cm larger than asymptomatic side 1 Pitting oedema confined to the symptomatic leg 1 Collateral superficial veins (non-varicose) 1 Previously documented DVT 1 An alternative diagnosis is at least as likely as DVT -2 1 1 Clinical probability simplified score Page 57 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Appendix 2 Referral for the diagnosis, investigation and management of abnormally swollen or painful leg(s) Patient Details NHS No: Male / Female (Please Circle) First Name: Surname: Title: DOB: Address: Contact Number: Referral Date: GP Referrer GP Name: GP Surgery: GP Contact Tel. No.: Other Referrer (if not GP) Name: Organisation: Contact Tel. No.: Clinical Details Clinical description: Date of onset of Symptoms: Other Symptoms as relevant: Page 58 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Two-level DVT Wells Score Score Please circle where appropriate Active Cancer (treatment ongoing, within 6 months, or palliative care) Paralysis, paresis, or recent plaster immobilisation of the lower extremities Recently bedridden ≥3 days or major surgery within 12 weeks requiring general or regional anaesthesia Localised tenderness along the distribution of the deep venous system Entire leg swollen Calf swelling 3 cm large than asymptomatic side Pitting oedema confined to the symptomatic leg Collateral superficial veins (non-varicose) Previously documented DVT Alternative diagnosis at least as likely as DVT 1 1 1 1 1 1 1 1 1 −2 Total score D-Dimer Has a D-dimer been carried out? If Yes, What was the result? Yes Positive No Negative Past Medical History: Current Medication: Drug Allergies: Name of referrer: Referrer Signature: Please Fax Referral to Hospital DVT/VTE Service AND telephone to confirm receipt of referral: Hospital DVT/VTE Service <Address of local service> Fax No.: 0161 <fax> Telephone No.: 0161 <phone> Page 59 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Appendix 3 Prescribing guideline for clinicians and patients choosing rivaroxaban to treat DVT The NICE single technology assessment reviewed and approved rivaroxaban for the treatment of DVT. It is still unclear who will most benefit from rivaroxaban but the following is a guide. Rivaroxaban should be considered in: Patients with a new diagnosis of DVT who after discussion of the risks and benefits opt for rivaroxaban Patients on long-term warfarin who have poor control (time in therapeutic range less than 55%) which is not felt to be due to intentional non-adherence Patients with other medical conditions that require regular introductions of medications which interfere with warfarin, e.g. COPD with antibiotics, and cause the need for very frequent INR monitoring/dose changes. Patients who are currently managed on LMWH because of difficulty in INR monitoring. Patients with poor mobility who find it difficult to attend outpatient clinics and/or require home visits. Rivaroxaban should be used with caution in patients with: Renal disease and impairment e.g. CKD stage 3 and 4 or eGFR <60mls/min Aged more than 75 years Patients who are planned to take anticoagulation indefinitely (more than 12 months) because of the lack of long-term safety data for rivaroxaban. Rivaroxaban should not be used in the following situations: Patients who are already on warfarin and well controlled, and who have not had adverse events. This is due to the lack of long-term safety data in this indication. History of gastrointestinal bleed Pregnancy or lactation Patients with active or recent (<6/12) diagnosis of cancer Patients with known antiphospholipid syndrome Patients with a target INR more than 3.0 Other indications for warfarin, except non-valvular atrial fibrillation * see separate guide for use of NOACs in stroke or non-valvular AF. Patients with known poor compliance, as missing a single dose may leave a patient under-anti-coagulated due to the short half-life of rivaroxaban Patients with eGFR < 30mls/min Rivaroxaban is suggested as an option which should be discussed with the patient in: Patients who have a suspected DVT and are awaiting appropriate imaging. Patients who have had a provoked DVT or first unprovoked DVT in whom a finite period of anticoagulation is required. Full details are available from the SPC Page 60 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate (http://www.medicines.org.uk/EMC/medicine/25586/SPC/Xarelto%2020mg%20filmcoated%20tablets/ ) Guide for new patients starting RIvaroxaban: Check FBC and coagulation screen, if low platelets or abnormal coagulation discuss with haematology. Check U&E – suggest avoiding if GFR less than 30mls/min Start rivaroxaban at 15mg twice daily for 3 weeks then 20mg daily thereafter. Monitor U&E at least every year if baseline normal, every six months if baseline abnormal. No requirement for coagulation monitoring. Patients switching from warfarin to Rivaroxaban Check U&E – suggest avoiding if GFR less than 30mls/min Stop warfarin and monitor INR daily, start rivaroxaban, as above, when INR less than 2.5 Monitor U&E at least every year if baseline normal, every six months if baseline abnormal. No requirement for coagulation monitoring. Patients switching from LMWH to Rivaroxaban Check U&E – suggest avoiding if GFR less than 30mls/min Stop LMWH and start rivaroxaban, as above, between 0-2 hours before next dose would have been due. Monitor U&E at least every year if baseline normal, every six months if baseline abnormal. No requirement for coagulation monitoring. RIVAROXABAN WILL CAUSE PROLONGATION OF THE COAGULATION SCREEN Management of patients having planned operative procedures If at all possible elective procedures should be delayed for as long after the thrombosis as possible. Note the half-life of rivaroxaban is approximately 5-13 hours. The half-life is considerably more in patients with kidney disease CKD 3/ or 4. A normal coagulation profile may indicate that the anticoagulant effect of the drug is no longer significant. Rivaroxaban can usually be restarted the following day when complete haemostasis has been secured but if there is concern over bleeding then re-introduction should be delayed, bridging therapy with LMWH may be required if there is a more than 24 hour delay. An individual risk assessment should be carried out and discussion between the surgical and haematology team and the patients GP. Emergency surgery on rivaroxaban Where patients require emergency surgery a full clotting screen with PT and APTT should be checked. Where results are normal, this suggests that the activity of rivaroxaban has ceased. Page 61 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate For prolonged clotting times, delay the procedure for as long as is safe to allow clearance of the drug. Early discussion with a haematologist is recommended and a bleeding management plan should be documented. Dental procedures on rivaroxaban Rivaroxaban at standard dose is approximately equitant to an INR of 2.5. Therefore dental procedures that previously would have been safely performed whilst on warfarin can be performed without interruption of rivaroxaban. Where possible the dental surgery should be planned for as late in the day as possible to ensure the lowed drug concentration. Patients should be advised to delay the following dose for up to 4 hours. Management of bleeding on rivaroxaban - see local Trust guidelines for management plans Prescribing Responsibilities Rivaroxaban was reviewed by NICE under a technology appraisal (TA261) for the treatment of DVT. The decision from NICE was to recommend rivaroxaban as an option for treating deep vein thrombosis and preventing recurrent deep vein thrombosis and pulmonary embolism after the diagnosis of acute DVT in adults. The main advantage of rivaroxaban over combination therapy with low molecular weight heparin followed by warfarin relates to the lack of monitoring required during treatment. However, there are other factors that should be considered when deciding to treat DVTs with rivaroxaban over warfarin. Rivaroxaban (Xarelto®) is a specific inhibitor of activated factor Xa with high oral bioavailability and a half-life of approximately nine hours. Secondary Care Responsibilities Diagnosis of DVT Ensuring other treatment options have been explored Discussion of risks/ benefits, initiation of treatment Provide initial 21 day therapy at recommended dose Advising GP on monitoring adverse drug reactions (ADRs) Liaison with the general practitioner (GP for continuation of supply) Providing written information to the GP stating the date when therapy should be reduced or stopped assuming no relapse in patient’s condition Responding to issues raised by GP after care of patient has been transferred GP Responsibilities Monitoring the patient’s overall health and well-being and observing patient for evidence of ADRs/abnormalities and raising with secondary care clinician if necessary. Clinical surveillance in line with anticoagulation practice throughout the treatment period Page 62 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Assessment of renal function at least once a year, or more frequently as clinical circumstances dictate when it is suspected that renal function could decline or deteriorate. Annual review as appropriate to include: History of any venous thromboembolic event in last year Reassessment of bleeding risk Prescription of drug after initiation by secondary care Ensuring advice is sought from the secondary care clinician if there is any significant change in the patient’s physical health status Reducing/stopping treatment in line with secondary care clinician’s original request Ensure patient has Yellow anticoagulant book for warfarin or Rivaroxaban alert card if patient has not already had one supplied Patient Responsibilities Report untoward effects to prescribing clinician Compliance with treatment Compliance with blood tests as detailed by prescribing clinician Informing other professionals as appropriate that they are receiving an anticoagulant Prescribing & Clinical Information Summary Summary of Product Characteristics (SPC) Xarelto (Rivaroxaban), Bayer. Available from eMC at http://emc.medicines.org.uk/ BNF prescribing information available at http://bnf.org/bnf/ Page 63 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Appendix 4: Counselling checklist for Warfarin Introduce yourself. Explain the medical condition requiring Anticoagulation. Explain how the drug works .i.e. ‘longer to clot not thinner’. Show the patient the Yellow Anticoagulant booklet and alert card. Tell them to take the book or alert card with them if they leave the house. Explain what the range means and what their desired range is. Tell them the intended duration of therapy. Explain the importance of blood monitoring and about our clinics. Show them the different strengths of tablets. Test the patient on dose adjustments to check understanding of dose changes. Tell the patient when to take the tablets .i.e. roughly same time each evening. Explain what to do if the patient misses a dose; i.e. If a dose is missed, it can still be taken on the day it was missed, otherwise continue the following day as per normal. Do not double up on dose. Advise INR clinic of any missed doses at next appointment. If an extra tablet is taken accidentally, patient to seek medical advice. Explain the signs of under / over dosage. Explain about local pressure after injection, laceration or venepuncture. Explain the risk of bleeding / bruising and what action to take in the event of bleeding, fall or head injury. Seek medical attention if blood in urine, faeces, vomit or sputum, vaginal bleeding (other than regular period), severe unusual headache Explain how to get repeat prescriptions. Tell the patient to inform other health care professionals .e.g. dentists that they are on oral anticoagulants. Explain the risk of potential drug interactions particularly antibiotics and over the counter drugs and to report medication changes to clinic staff immediately. Advise patient to inform us of changes to health lasting more than 4 days .e.g. pain, D&V, flu. Explain about the risk of herbal drug interactions and tell the patient to check safety with clinic staff before purchase. Explain that dietary changes may affect control. No Cranberry products or Aspirin unless agreed by medical staff. Inform the patient of safe alcohol intake limits. If the patient is female and could possibly become pregnant explain the risks and actions to take if a period is missed. Discuss the risk of contact sports if applicable. Ask if the patient has any other questions. I confirm that (counsellor) ________________________ has given me the above verbal information, a fact sheet on oral Anticoagulant therapy and an initial supply of Warfarin. Patient name Signed (patient) NHS No - Date - Page 64 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Appendix 5: Counselling checklist for Rivaroxaban Introduce yourself. Explain that Rivaroxaban is being prescribed to treat a DVT and reduce risk of embolism. Explain how the drug works .i.e. ‘blood takes longer to clot not thinner’. Show the patient the information booklet and alert card. Advise the patient to put the alert card in a purse or wallet. Explain the initial intended duration of therapy and review arrangements. Explain the dose to take .i.e. 15mg TWICE daily for 3 weeks then 20mg ONCE daily thereafter. Swallow whole and take with food. Advise the patient of what to do if misses a dose; i.e. If a dose is missed, it can still be taken on the day it was missed, otherwise continue the following day as per normal. Do not double up on dose. If an extra capsule is taken accidentally, advise patient to seek medical advice Advise patient to apply local pressure after injection, laceration or venepuncture. Explain the risk of bleeding / bruising and what action to take in the event of unexpected bleed, fall or head injury. No direct antidote but local procedures in place to deal with bleeding. Explain how to get repeat prescriptions. Advise the patient to inform any health care professionals .e.g. doctors / dentists that they are on Rivaroxaban. Explain the risk of potential side effects / adverse events and to report concerns to GP immediately. Seek medical attention if any blood in urine, faeces, vomit or sputum, vaginal bleeding (other than regular period), severe unusual headache No Aspirin unless agreed by medical staff. If the patient is female and could possibly become pregnant explain the risks and actions to take if a period is missed. Discuss the risk of contact sports if applicable. Ask if the patient has any other questions. I confirm that (counsellor) ________________________ has given me verbal information, a fact sheet and Patient Alert Card for Rivaroxaban. I have been given an initial supply of Rivaroxaban. Patient name Signed (patient) NHS No - Date - Page 65 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate Appendix 6: Full pathway for the diagnosis, investigation and management of abnormally swollen or painful leg(s) Patient with abnormally swollen or painful leg(s)* GP (a1) Community DVT service if one exists locally** (a1b) A&E (a2) On hospital ward (a3) Hospital DVT/VTE Service (b) Provide or pursue an alternative diagnosis (c2) Ultrasound (c1) Review post ultrasound scan (d) Proven DVT (d1) DVT unexplained (d1.1) Pursue further tests to find reason for DVT (e1) Not DVT (d2) DVT explained (d1.2) Alternative diagnosis provided (d2.1) GP or return to ward (e2) Referral to continue to (d2.1) pursue alternative diagnosis (e3) Review of treatment where necessary (f1) * Patient with abnormally swollen or painful leg(s)* identified as newly abnormal swollen or painful leg(s) or newly noticeable/significant swelling or pain on already swollen or painful leg(s). Red text related to GP’s. Community DVT service if one exists locally** - refers to a DVT service in a central location in the community that provide baseline tests and aim to reduce hospital admissions. A1b is additional to this pathway Page 66 of 67 Greater Manchester, Lancashire & South Cumbria Strategic Clinical Network & Senate DVT Steering Group (who developed this pathway) Mark Holland Gareth Lord Charles McCollum Peter Elton Anita Sharma Daniel Horner Dhirendra Allen Michelle Grundy Wendy Morrison Elizabeth Lamberton Syed Zafar Jurjees Hasan Beatrice Fox Vicky Hoskins Sarah Jacobs John Bright David Thomson Irene Lorenzelli Suresh Chandran Tariq Sharf Arun Kallat George Ajith Allie Babak Sarah Thackery General Medical Consultant (UHSM) Quality Improvement Manager (SCN) Vascular Surgeon (UHSM) Clinical Director (SCN) GP and CCG Lead for Vascular (Oldham CCG) Clinical Research Fellow (CMFT) Consultant (THT) AC Manager (RBH) DVT Clinic Sister (RBH) Pharmacist (SRFT) Consultant (WWL) Medical Oncologist (Christie) Consultant Nurse (RBH) Pharmacist (UHSM) Senior Strategic Pharmacist (GMCSU) Consultant (CMFT) Consultant Physician (PAT) Patient Participation Member (Oldham) Consultant (PAT) Programme Management Office Controller (Oldham CCG) Consultant (RBH) Consultant (CMFT) Consultant (TGH) Vascular Nurse (TGH) Page 67 of 67