t. P.A. total Plasminogen Activator

advertisement
t. P.A.
tissue
Plasminogen
Activator
Presented by:
Kelly Banasky, RN, BSN
GCH Emergency Services Educator
What is tPA?
• tPA is a thrombolytic drug also known as Alteplase
or Activase
• Used for AMI, PE, Acute Ischemic Stroke (AIS)
• The dosage for AIS is less than the dosing for AMI or PE
• tPA disrupts the integrity of a thrombus, plaque or
emboli within a blood vessel
• It is the ONLY thrombolytic agent approved by the
FDA for the treatment of AIS
• Other Thrombolytics had unacceptably high hemorrhage
rates or were not tested extensively to establish risk versus
benefits.
How it works
• Upon administration:
•
•
•
•
Binds the fibrin in a clot
Converts the trapped plasminogen to plasmin
Initiates fibrinolysis
Limited systemic proteolysis (breakdown into smaller
fragments)
• Has a small window of time in which it can be
administered and requires close monitoring post
administration.
• Within 3 hours of symptom onset
• In some cases, based on criteria, a 3 to 4.5 hour window
is possible.
Eligibility for inclusion
• Patients with a Negative for Hemorrhage head CT scan may
receive tPA ONLY IF the following conditions are met:
• Must be 18 years of age or older
• Have a clinical diagnosis of stroke with a measurable
deficit
• Onset of symptoms:
• < (less than) 3 hours
• If > (greater than) 3 hours, but < (less than) 4 ½ hours
if eligible based on additional exclusion criteria
• Must have a reviewed CT of the head with Negative for
Hemorrhage result.
• Lab studies must be reviewed
Absolute Exclusions for tPA
• Evidence of ICH on CT Scan
• Clinical presentation suggestive of
a SAH
• Active internal bleeding
• Intracranial surgery, serious head
trauma or previous stroke within 3
months
• Any history of ICH, AVM or
aneursym
• Blood Pressure: If BP can not be
controlled after 2 attempts to
lower.
• Systolic > 185
• Diastolic > 110
• Glucose ≤ 50 per BGM
• Known bleeding diathesis
including:
• Platelet count < 100,000
• On Heparin (within 48
hours) &  PTT
• INR ≥ 1.7
• Low molecular weight
heparin administered in the
past 24 hours at therapeutic
doses. (Excludes
prophylactic doses)
Additional Exclusion Criteria
3 hours to 4.5 hours
•
•
•
•
•
This criteria is specific for 3 to 4.5 hours after symptom onset
Age > 80
Major neurological deficits with a NIHSS greater than 25
History of stroke AND diabetes
Receiving anticoagulant therapy regardless of INR, PT/PTT
Cautions and Warnings
• Minor symptoms with rapid improvement
• Major Neurological deficits (multi-lobar) of the CT > 1/3
of the cerebral hemisphere
• Major surgery or trauma (excluding head trauma) within
14 days.
• History of frank GI or GU hemorrhage within 21 days
• Arterial puncture in a NON-compressible site within 7
days
• Acute MI in previous 3 months (non concurrent)
• Seizure at onset of stroke symptoms suggestive of postictal neurological impairment
Dosing
• tPA is based on weight
• 0.9mg/kg
• Pharmacy requires the weight to properly dose
• Maximum dose ANY patient can receive is 90
mg.
• Is a 2-part administration process
• IV Bolus
• 1 hour infusion
• Requires multiple safety checks from pharmacy
prior to pick up by nursing
Administration
• 1st part:
• 10% of the total dose is administered as IV bolus
• The bolus is administered over 1 minute IVP
• 2nd part:
• Remaining 90% is infused over 60 minutes
• Must be administered on IVAC
• Vital signs & NIHSS (nursing) every 15 minutes
during administration
Complications and Side Effects
• The most common complication with tPA
administration is bleeding. Bleeding is further
broken down into two broad categories
• Internal: Intracranial, retroperitoneal, or GI, GU and
Respiratory tracts
• Superficial: invaded or disturbed sites:
• venous cut-downs
• arterial and venous punctures
• catheter insertion sites
• needle puncture sites
• sites of recent surgical intervention
Necessary Precautions
• Avoid IM injections
• Use extreme caution with veni-punctures; only perform
as required
• If arterial puncture is needed during infusion or after,
utilize upper extremity. Manual compression will be
required.
• Pressure to be applied for 30 minutes
• Pressure dressing to be applied to site
• Frequent checks of the puncture site
•
•
•
•
•
Seizure Precautions
Bedrest x 24 hours
HOB at 30°, place tPA sign above bed
NPO until evaluated by Speech Therapy or Neurology
SCD’s
Post tPA Assessment/Documentation
• Vital Signs AND NIHSS (by nurses)
• q 15 minutes x 2 hours from start of tPA THEN
• q 30 minutes x 6 hours THEN
• q hour x 16 hours
• Temps q 4 hours x 24 hours
• Continuous Pulse Oximetery
• Blood glucose (may require tight glycemic control)
• Initial
• every 6 hours if NPO
• AC & HS once patient is eating for 48 hours
• notify physician if blood glucose is > 140
Monitoring
• Patients who receive tPA need to be closely
monitored
• The first 24 hours after tPA administration is
critical with a risk of hemorrhage
• Vital signs will require close monitoring
• While the risk is concerning, the benefit outweighs
the risk as quality of life is greatly changed.
Facts to consider with tPA
• tPA does NOT come pre-assembled and mixed
• Is very expensive
• $3,300 per dose
• Requires multiple safety checks prior to administering.
• Requires a weight to dose appropriately
• Anti-platelet medications and Heparin will not be
administered until 24 hours post tPA administration
tPA is also time sensitive
Special Thanks to the following people who
were willing to be photographed:
•
•
•
•
•
•
•
•
•
May Alsamarae RPh
Kim Babcock RPh
Barb Bishop PharmD
Melanie Deron, RN
Dr. Jason Gumma
Paul Hotycki, CPhT
Colleen Kargenian, NT
Amy Millsaps, RN
Amal Sobh PharmD
Resources
•
•
•
•
•
•
•
•
•
•
Disclaimer: NO PHARMACISTS WERE HURT IN MAKING THIS PRESENTATION
American Heart Association/American Stroke Association 2010 http://www.strokeassociation.org
Garden City Hospital Pharmacy Services
Dr. Brian Kim
Dr. Anna Pawlak
Del Zoppo et. Al. (2009) Expansion of the Time Window for Treatment of Acute Ischemic Stroke with
Intravenous Tissue Plasminogen Activator: A Science Advisory From the American Heart
Association/American Stroke Association Retrieved Electronically from stroke.ahajournals.org
Thomas, Jennifer (2010) Patients Do Better at Hospitals That Follow Stroke Guidelines Chances of
survival were higher study shows retrieved electronically from Circulation: Cardiovascular Quality and
Outcomes
Michigan Stroke Network (2010) Possible IV-rt-PA (Activase) Candidate (Inside a 3-hour window or < 180
minutes from symptom onset)
Otwell, J, et. Al. (2010) Efficacy and safety of i.v. alteplase therapy up to 4.5 hours after acute ischemic
stroke onset Am J Health Syst Pharm – Vol 67-July 1, 2010 pp 1070-1074
Genentech © (2005) Activase Prescribing Information retrieved electronically from www.activase.com
Download