Title Document Number Version Number Name, Date and version number of previous document (if applicable) Staff involved in development Staff with overall responsibility for development implementation and review Development period Date approved by Clinical Guidelines committee Signed by the Chair Clinical Guidelines Committee Anticoagulation for Invasive Procedures in Patients on Warfarin CG230 2 Anticoagulation for Invasive Procedures in Patients on Warfarin, approved 2007 Dr J M Voke & Dr D S Thompson, Consultant Haematologists Dr M Evans, Chief Pharmacist Miss K Brown, Consultant Surgeon Dr S Yogasakaran, Consultant Anaesthetist Dr N Simmonds, Consultant Gastroenterologist Miss K Brown, Chairman, Thrombosis Committee Up to ’07 Revision Aug- Oct ‘09 Original ‘07 Revision: November 2009 M Griffiths Date for review October 2011 Key words Anticoagulation, warfarin, heparin, enoxaparin, vitamin K, surgery, invasive procedures June 2009 Date document was Equality Impact Assessed: JV/ME/KB rev Nov 09 0 of 12 ANTICOAGULATION for INVASIVE PROCEDURES in ADULT PATIENTS on WARFARIN Elective Procedures on warfarin (Group A) Elective Procedures after stopping warfarin (Group B) Elective Procedures requiring transfer to LMW heparin (Group C) page 1 page 2 page 2 Emergency Procedures Endoscopic procedures (from BSG guidelines) Bridging high risk patients with LMW heparin Classification of thrombotic risk and bleeding risk - Appendix 1 Practical information for doctors and nurses - Appendix 2 References Group A, B and C letters for patients Letter requesting nurse to give LMWH injections page 2 page 3 page 4 page 5 page 6 page 7 pages 8-10 page 11 • These guidelines are for the use of clinical staff in the management of patients on full dose oral anticoagulation undergoing invasive surgical procedures • Guidelines should be used to aid individual clinical decisions, not replace them • The best available evidence on which these guidelines are based, is mainly grade 2B & 2C, ie it is scientifically weak evidence, therefore individual clinical judgement remains important. • The risk of thromboembolism needs to be balanced against the risk of surgical haemorrhagic complications in each patient. • For major and moderate surgery, once warfarin has been stopped and the INR is less than 1.8, additional prophylaxis according to the surgical thromboprophylaxis guidelines may be given (TED stockings and, for some patients, intermittent pneumatic compression foot pumps) until the INR returns to the desired range. • If surgical complications occur, use intravenous standard heparin, not warfarin or low molecular weight heparin (LMWH), to allow faster anticoagulant adjustment. • If management uncertain or high risk, discuss with Consultant Haematologist. MANAGEMENT OF ANTICOAGULATION FOR ELECTIVE PROCEDURES* Elective surgery should be postponed when this is safe, until full dose anticoagulation has been stopped, eg. in patients anticoagulated for 3 - 6 months following a first episode of venous thromboembolism. GROUP A For procedures* with a low risk of surgical bleeding (see Appendix 1) WARFARIN CAN BE CONTINUED Pre-op • Give the patient or carer a copy of the Patient Information Sheet for Group A patients (page 8) • Patient (or carer) to inform Anticoagulant clinic (AC clinic) of procedure and date so that an extra appointment for INR can be made a week before the procedure on the usual dose of warfarin. • If INR >3.0, the AC clinic will reduce warfarin dose for a week before the procedure to give INR 2-3. • Check INR on day before procedure. INR < 3 is usually acceptable. • If the INR is above 3, ask the patient or carer to phone the consultant’s secretary for instructions. • If INR below 3, ask the patient to bring their yellow anticoagulant booklet to the hospital on the day of the procedure. • If necessary, also check INR on day of procedure and proceed if INR <3. Post-op • • • • If warfarin has been reduced, restart at patient’s normal dose on the day of surgery. Aim to re-establish therapeutic anticoagulation without delay Give prophylactic enoxaparin if INR <2 in patients with high thrombotic risk (Appendix 1). For oral haemostasis, tranexamic acid mouthwash can be used to aid surgical measures. * Day case or Inpatient Invasive Procedures JV/ME/KB rev Nov 09 1 of 12 GUIDELINES ON THE MANAGEMENT OF ANTICOAGULATION FOR SURGERY* when there is a high risk of surgical bleeding (Appendix 1) GROUP B WARFARIN TO BE STOPPED. No heparin bridging needed as low to moderate thrombotic risk (Appendix 1) Pre-op • Stop warfarin 5 days before surgery*. • Check the INR the day before surgery. • If the INR is 1.5 or higher, repeat on the day of the procedure. Target INR for surgery in this group should be <1.5 • If INR remains >1.5, delay surgery or consider active reversal of anticoagulation (see below Emergency Procedures) Post-op • Restart patient’s normal dose of warfarin on the evening of surgery unless there has been excess bleeding. GROUP C WARFARIN TO BE STOPPED. Heparin bridging needed as high thrombotic risk (Appendix 1) Pre-op • Discontinue warfarin 5 days before surgery.* • Prescribe enoxaparin to start in the morning 3 days before surgery (for doses & timing see page 4) and arrange for the patient or carer to learn to give the injections. • Check INR the day before surgery and, if necessary, also on the day of the procedure. See above for INR required. • Do not give full dose enoxaparin on the evening before the procedure. • Prophylactic enoxaparin 40mg sc can be given 12 hours pre-op. Post-op • Restart patient’s normal dose of warfarin on the evening of surgery unless there has been excess bleeding. • After morning surgery give enoxaparin 40mg sc 6hrs post-operatively (not after 8pm). • Restart enoxaparin the next morning, dose as per chart page 4. • Continue enoxaparin for 3 days or until INR therapeutic again. • If the patient remains in hospital post-op, additional INR can be checked 4 days after restarting warfarin. * Day case or Inpatient Invasive Procedures EMERGENCY PROCEDURES 1. 2. 3. 4. Stop anticoagulants unless patient is in Group A with INR <3 (see previous page). Take blood samples for INR, FBC, cross-match & other tests if indicated. If INR is > 1.5 and procedure requires lower INR (Groups B & C), give FFP 15ml/kg. If INR is > 3.0 also give iv vitamin K 1mg slowly. (Anaphylaxis can occur with iv vitamin K). With larger doses of vitamin K the patient will be refractory to warfarin for 3-4 days. If no further oral anticoagulation is required, 5mg iv vitamin K can be given followed by daily oral vitamin K 10mg for 3-4 days. 5. See Octaplex (prothrombin complex concentrate) guidelines if there is severe bleeding. 6. Repeat INR 20-30 minutes after the FFP or Octaplex. 7. When INR is satisfactory proceed with operation. Give post-op enoxaparin and re-establish oral anticoagulation as described above. If management uncertain or high risk, discuss with Consultant Haematologist. JV/ME/KB rev Nov 09 2 of 12 Luton and Dunstable Hospital Guidelines for the management of patients on warfarin or clopidogrel undergoing endoscopic procedures, biopsies and other invasive investigations adapted from British Society for Gastroenterology & BCSH guidelines 2008 - Gut 2008: 57: 1332-1329 http://www.bsg.org.uk/bsgdisp1.php?id=87d6c937c883a1bf5f2a&h=1&m=00023 This page is part of ‘Guidelines on the Management of Invasive Procedures in Anticoagulated Patients’ on the L&D Intranet Low Risk Procedure High Risk Procedure - Diagnostic procedures +/- biopsy of - Polypectomy - Liver biopsy - ERCP with sphincterotomy - EMR - Dilation of strictures - Therapy of varices - PEG - EUS with FNA non-vascular tissue - Biliary or pancreatic stenting - Diagnostic EUS Warfarin Continue warfarin - Check INR 1 week before Clopidogrel Continue clopidogrel procedure - If INR <3 continue usual daily dose - If INR above 3 reduce daily dose until INR <3 - Recheck INR before procedure Low Risk Condition Low Risk Condition - Prosthetic aortic valve - Xenograft heart valve - AF without valvular disease - >3months after VTE Stop warfarin 5 days before procedure - Check INR prior to procedure to ensure INR<1.5 - Restart warfarin evening of procedure with usual daily dose - Check INR 1-2 weeks later at the patient’s usual clinic High Risk Condition - Prosthetic mitral valve - Any prosthetic heart valve and AF - AF with mitral stenosis - <3months after VTE - Previous VTE with signif. thrombophilia* - Other high risk venous or arterial thromboembolic indications for warfarin Stop warfarin 5 days before procedure - Start LMWH** 2 days after stopping warfarin -Omit LMWH on the evening before and on the day of the procedure - Check INR prior to procedure to ensure INR<1.5 - Restart warfarin evening of procedure with usual daily dose - Continue LMWH** for 3 days after the procedure or until INR therapeutic * eg antiphospholipid syndrome, antithrombin deficiency, complex inherited thrombophilias. Discuss with Haematologist **See next page for details of LMWH doses JV/ME/KB rev Nov 09 Clopidogrel Warfarin - Ischaemic heart disease without coronary stent - Cerebrovascular disease - Peripheral vascular disease High Risk Condition Coronary artery stents Liaise with cardiologist Stop clopidogrel 7 days before procedure - Continue aspirin if already prescribed - If not on aspirin, then consider aspirin therapy while clopidogrel stopped Consider stopping clopidogrel 7 days before procedure if - >12 months after insertion of drugeluting coronary stent - >1 month after insertion of bare metal stent Continue aspirin Key: EUS: endoscopic ultrasound ERCP: endoscopic retrograde cholangiopancreatography EMR: endoscopic mucosal resection, PEG: percutaneous endoscopic gastroenterostomy, LMWH: low molecular weight heparin FNA: fine needle aspiration, INR: international normalised ratio, AF: atrial fibrillation, VTE: venous thromboembolism 3 of 12 Bridging with low molecular weight heparin (LMWH) When patients at high risk of thromboembolism are having a high risk procedure (see green boxes on previous page) the bridging regime below is recommended and a morning procedure should be arranged whenever possible. • Stop warfarin 5 days before the procedure. • Always assess risk factors for bleeding as well as thrombosis before following these recommendations. • Guidelines on regional anaesthesia must be followed for timing of anticoagulant doses in relation to epidurals and regional anaesthetic injections. (Add Hyperlink to these guidelines) LMWH recommended Day pre- or postprocedure Warfarin Venous indication for LT anticoagulation (see page 5) Prosthetic mitral valve or other cardiac indication (see page 5) Day -5 No warfarin - - Day -4 No warfarin - - Day -3 No warfarin Enoxaparin 40mg sc 12 hourly Enoxaparin 1.5 mg/kg sc once daily in the morning Day -2 No warfarin Enoxaparin 40mg sc 12 hourly Enoxaparin 1.5 mg/kg sc once daily in the morning Day -1 No warfarin Enoxaparin 40mg sc 12 hourly Enoxaparin 1.5 mg/kg sc at 8am Day of procedure Restart warfarin on evening of procedure at patient’s usual dose Day 1 post Continue daily warfarin Enoxaparin 40mg sc 12 hourly Enoxaparin 1.5 mg/kg sc once daily, in the morning if no excessive bleeding Day 2 post Continue daily warfarin Enoxaparin 40mg sc 12 hourly Enoxaparin 1.5 mg/kg sc once daily in the morning Day 3 post Continue daily warfarin Enoxaparin 40mg sc 12 hourly Enoxaparin 1.5 mg/kg sc once daily in the morning Day 4 post Continue daily warfarin Stop LMWH Stop LMWH No LMWH until 6 hours post-op when prophylactic enoxaparin 40mg sc can be given if there has been no excessive bleeding • Patients (or carers) should be taught to give injections themselves whenever this is possible, to allow LMWH to be given at home before and after hospital admission, when appropriate • For patients with renal dysfunction, see BNF Appendix A3 for enoxaparin dose adjustment JV/ME/KB rev Nov 09 4 of 12 APPENDIX 1 CLASSIFICATION OF THROMBOTIC RISK and BLEEDING RISK THROMBOTIC RISK if warfarin temporarily stopped Original clinical indication for anticoagulants Low to moderate thrombotic risk no bridging needed • 3 months since acute VTE with no significant thrombophilia* • AF without valve disease • Tissue valve replacement, not in AF • Prosthetic aortic valve, not in AF • Other low risk venous or arterial thromboembolic indications for warfarin High thrombotic risk requiring bridging LMW heparin • VTE within last 3 months • Prosthetic mitral valve • AF with - any prosthetic valve - mitral stenosis - previous cardio-embolic event • Previous VTE with significant thrombophilia* • Other high risk venous or arterial thromboembolic indications for warfarin * eg antiphospholipid syndrome, antithrombin deficiency, complex thrombophilia: discuss with Haematologist. Examples of risk of surgical bleeding associated with invasive procedures when patient is not on an anticoagulant or anti-platelet drug Low risk of bleeding High Risk of Bleeding • Skin biopsy & excision of minor skin lumps where pressure can be directly applied • Banding of piles and other superficial venous procedures • Some endoscopic procedures (page 3) including diagnostic endoscopy +/- biopsy of non-vascular tissue, biliary or pancreatic stenting, diagnostic endoscopic ultrasound • • • • Invasive surgery Regional anaesthetic techniques Liver biopsy Some endoscopic procedures (page 3) including polypectomy, ERCP with sphincterotomy, EMR, dilation of strictures, therapy of varices, PEG, EUS with FNA Guidelines should be used to aid individual clinical decisions, not replace them JV/ME/KB rev Nov 09 5 of 12 APPENDIX 2 Information for Doctors & Nurses Managing Anticoagulation before and after Surgical Procedures, Endoscopic or X-ray guided Biopsies and other Invasive Investigations. Assessment of risk: The doctor who informs the patient that the procedure is needed must also assess the risk of thrombosis and bleeding. There are 3 groups, as below, with a separate Patient Information Sheet for each group. Group A - continue warfarin as low risk of surgical bleeding due to the procedure. Follow guidelines on page 1 for GROUP A patients. Group B - stop warfarin for 5 days to reduce risk of surgical bleeding due to the procedure. Follow guidelines on page 2 for Group B patients. Group C - stop warfarin for 5 days to reduce risk of surgical bleeding due to the procedure. Conditions listed as ‘high thrombotic risk’ are given in Appendix 1. Heparin bridging is needed for these patients. Follow guidelines on page 2 for Group C and transfer to LMWH – dose & timing details are given on page 4. Prescriptions for Group C When LMWH is required for bridging, the prescription for the appropriate pre-filled syringes of LMWH must be given with advice about home injections at the time the procedure is agreed with the patient. The number of syringes needed for home injection will depend on when the patient is to be admitted. Full dose LMWH should not be prescribed for the evening before the procedure. Note the different enoxaparin doses recommended for venous and cardiac indications (see table page 4). Doses for obese and underweight patients must be discussed with the consultant in charge but do not usually need to be altered. See BNF for doses for patients with renal dysfunction. Injections at home 1. At the time the prescription is written, give an explanation for the temporary transfer from warfarin to LMWH 2. Patients (or carers) must be asked if they would be willing to learn to give their injections at home. This should be encouraged to avoid unnecessary admissions. Injection technique can be taught in the Day Unit (ext 8106/7), on the ward or at the GP’s surgery. Ensure that an appropriate appointment is made and that the patient understands where to go for training. 3. If the patient or carer cannot give injections, and early admission is impossible, arrange for a district nurse to visit. 4. Pre-printed letters ‘Patient Information & Heparin Record Sheet for Home Treatment’ are available from the Day Unit, the Anticoagulant Clinic Clerk or the Haematology Secretary ext 7214. Retrieval of INR results before the procedure: ϖ Check INR results in the patient’s own Anticoagulant record book or on ICE ϖ The INR should be INR < 3 at the Anticoag clinic the week before a low bleeding risk procedure and <1.5 the day before a high bleeding risk procedure. ϖ INR requests on the day of the procedure should be labelled ‘urgent’ and samples taken and delivered to the haematology lab as soon as the patient arrives in the ward, endoscopy unit or department. Rarely a patient’s procedure may have to be delayed if the INR remains 1.5 or above even after warfarin has been stopped for 5 days. In this case, check LFTs. After the procedure Patients who have had no excess bleeding during the procedure should restart daily warfarin on the evening of the procedure at their usual dose (no high loading dose) unless an epidural catheter is still in place, when warfarin should be delayed (also see Anaesthetic guidelines for timing of epidural insertion & removal in relation to heparin injections). For patients having bridging LMWH, check that they have the 3 days supply of LMWH injections to give at home and that they are back on warfarin at their usual dose. Patients should attend their planned anticoagulant clinic appointment or move their appointment forward to 1 week if there have been any complications or changes in medicines. JV/ME/KB rev Nov 09 6 of 12 References 1. 2. 3. 4. 5. 6. Eighth ACCP Consensus Conference on Antithrombotic Therapy. Chest 133 (6), June 2008 Supplement Veitch A et al for the BSG & BCSH. Guidelines for the management of anticoagulant and antiplatelet therapy in patients undergoing endoscopic procedures Gut 2008: 57(9):1322-9 British Soc for Haem Guidelines on Oral Anticoagulation. BJHaem 1998; 101: 374-387 Guidelines on oral anticoagulation (warfarin): third edition – BCSH guidelines 2005 update BCSH guidelines, H&T Task Force, Hospital Medicine 2000, 61, 644 Baglin T et al for the BCSH. Managing bleeding and excessive anticoagulation. BJHaem 132 (3) 277, 2006 JV/ME/KB rev Nov 09 7 of 12 INFORMATION FOR PATIENTS in GROUP A Management of Warfarin for Invasive Surgical Procedure, Biopsy or Investigation when risk of bleeding is low and warfarin does not need to be stopped CONTINUE WARFARIN 1. You do not need to stop warfarin before the procedure as there is a low risk of bleeding. 2. Let the anticoagulant clinic nurses know ϖ the date & nature of the procedure ϖ that you do not need to stop warfarin ϖ that you need an INR test a week before the procedure The Anticoagulant Clinic number is 01582 497537 3. If your INR is above 3, the Anticoagulant Clinic nurse will reduce your dose for a week before the procedure to ensure that the INR is below 3 on the day of the procedure. 4. Bring your yellow warfarin dose record book with you when you come in for the procedure as the doctors will want to check that your INR is below 3. 5. After the procedure, continue warfarin at your usual dose or the dose advised by the Anticoagulant clinic nurse and keep your usual next Anticoagulant clinic appointment. JV/ME/KB rev Nov 09 8 of 12 INFORMATION FOR PATIENTS in GROUP B Management of Anticoagulation for Invasive Surgical Procedure, Biopsy or Investigation when warfarin needs to be stopped for 5 days NO ‘BRIDGING’ HEPARIN NEEDED as risk of thrombosis is low 1. Before the procedure: you need to stop warfarin 5 days before the operation or endoscopy. 2. You will not need heparin injections as bridging anticoagulation 3. Your surgeon or endoscopy consultant will give you a request form for an INR test the day before the procedure (the fifth day off warfarin). Bring the form to the Pathology Outpatient Dept for the blood test before 2pm on the day before the procedure. 4. The result of the INR test will be checked by a doctor from the surgical or endoscopy team. If the INR is too high (1.5 or above) they will ask you to have another INR check on the morning of the procedure, when your INR is likely to be lower. 5. After your procedure restart your normal dose of warfarin the same evening and continue that dose until your next anticoagulant clinic appointment. It takes a few days for warfarin to have its full effect so you do not need an extra INR test in the week after your procedure. 6. Keep your usual anticoagulant clinic appointment, as recorded in your yellow warfarin dose book. JV/ME/KB rev Nov 09 9 of 12 INFORMATION FOR PATIENTS in GROUP C Management of Anticoagulation for High Risk Invasive Surgical Procedure, Biopsy or Investigation requiring BRIDGING Heparin when Warfarin stopped 1. Before the procedure: you need to stop warfarin 5 days before the operation or endoscopy. 2. A prescription for heparin injections (enoxaparin) will be given to you by your hospital doctor when you discuss the procedure. This ‘bridging’ anticoagulation is to be given for 3 days before and after the procedure. The prescription will be for pre-filled syringes of enoxaparin 3. Take your prescription to the hospital pharmacy and collect the enoxaparin syringes. If you prefer to collect them from a community pharmacy, allow 2-3 days extra in case they need to be ordered 4. Learn how you (or your relative or carer) can give the injections at home. Phone your General Practice nurse or the Day Unit sister (01582 718106) to arrange an appointment to be taught how to give the injections if you have not given injections before: 5. Bring this letter (see reverse) and the injections with you when you come for the training session. 6. Give your subcutaneous enoxaparin injections as advised by the doctor on the 3 days before and the 3 days after your procedure. Patients on the once daily high dose of enoxaparin should give it in the morning each day and no injection should be given the evening before surgery. Patients having the lower 12 hourly dose of enoxaparin should have a dose before 8pm on the evening before the procedure. 7. Your surgeon or endoscopy consultant will give you a request form for an INR test the day before the procedure (the fifth day off warfarin). Bring the form to the Pathology Outpatient Dept for the blood test before 2pm on the day before the procedure. 8. The result of the INR test will be checked by a doctor from the surgical or endoscopy team. If the INR is too high (1.5 or above) they will ask you to have another INR check on the morning of the procedure, when your INR is likely to be lower. 7. After the procedure restart your normal dose of warfarin the same evening and continue that dose until your next anticoagulant clinic appointment. It takes a few days for warfarin to have its full effect so you do not need an extra INR test in the week after your procedure. 8. Continue with the injections of enoxaparin as prescribed by the doctor for 3 days after the procedure (unless there is excess bleeding) then stop the injections, continuing the warfarin. 9. Keep your usual anticoagulant clinic appointment, as recorded in your yellow warfarin dose book. JV/ME/KB rev Nov 09 10 of 12 Please take this letter to the nurse when you attend for training in subcutaneous injection technique. It is helpful if you take your injections along as well. Date ………………………… Dear …………………………………..…. (Day Centre sister / Practice nurse / District nurse) Patient ID This patient is booked for (type of procedure)…………………………………………….. on (date)…………………………….. and has been asked to stop warfarin for 5 days before the procedure. Bridging heparin (enoxaparin) injections have been prescribed for 3 days before and after the procedure. The dose of enoxaparin is …………. mg once daily every morning subcutaneously or 40mg every 12 hours subcutaneously (delete as required) from (date) …………………………… to (date) ………………………………… Thank you for teaching the patient / relative / carer to give the subcutaneous injections. If there are any queries, please phone ……………………………………. Yours sincerely Print name …………………………………….. On behalf of Dr/Mr ………………….. Consultant ……………………… JV/ME/KB rev Nov 09 11 of 12