Thrombolysis Protocol  

05 November 2004

Acute Ischemic Stroke is a medical emergency. The Stroke Council of The American Heart Association has made recommendations based on the NINDS Study. These recommendations are summarized as follows:

·     The administration of recombinant tissue plasminogen activator (t-PA) improves the outcome after stroke when given very early, and within 3 hours of onset of stroke in carefully selected persons.

·      If the 3 hour time window can be met treatment can be beneficial irrespective of patient’s age, gender, ethnicity, or presumed cause of stroke.

·      Treatment can be beneficial for persons with a wide spectrum of neurological deficits.

·       A significant increase in improvement at 24 hours and favorable outcomes at 3 months were noted among persons treated with t-PA.

·      The administration of thrombolytic drugs to persons with     acute ischemic stroke can be complicated by bleeding  even if the drug is given within 3 hours.

·      The risk of intracranial hemorrhage in persons with acute ischemic stroke is much greater than the risk of bleeding in persons who receive thrombolytic drugs for the management of myocardial ischemia.

·      Symptomatic intracranial hemorrhage was significantly increased with treatment but despite the hemorrhages, the rate of death or severe disability was less in the actively treated groups.

·      The benefit of intravenous t-PA for acute ischemic stroke beyond 3 hours from the onset of symptoms is not established and cannot be recommended. Intravenous t-PA is not recommended when the time of onset of stroke can not be ascertained reliably, including strokes recognized upon awakening.

CONTRAINDICATIONS:

·         Age less than 18 years old.

·         Evidence of intracranial hemorrhage on pretreatment CT.

·         Coma, or severe obtundation.

·         Symptoms rapidly improving or minor (not measurable by the NIH Stroke Scale).

·         Known bleeding diathesis, including but not limited to: 1) Platelet count < 100,000, 2) current use of oral anticoagulants or, 3) PT > 15 sec, INR > 1.7, 4) use of heparin in the previous 48 hours and a prolonged PTT.

·         Serious head trauma or previous stroke within 3 months.

·         Seizure at the onset of stroke.

·         Major surgery or major trauma within 14 days.

·         Arterial puncture at a noncompressible site or LP within 7 days.

·         GI or urinary tract bleeding within 21 days.

·         Pretreatment SBP > 185 or DBP > 110, despite simple measures.

·         History of intracranial hemorrhage.

·         Abnormal blood glucose (< 50 or > 400 mg/ dL)

·         Recent MI complicated by pericarditis.

·         Pregnant or lactating females (menstruation is not a contraindication).

·         Early changes on CT such as sulcal effacement, mass effect, or edema are not absolute contraindications. If these signs are present then it suggests a longer interval between stroke onset and the CT scan than 3 hours. Immediate efforts must be made to re-establish the time of onset of neurological symptoms.

EMERGENCY DEPARTMENT MANAGEMENT FOR PATIENTS PRESENTING
WITH NEW ONSET STROKE SYMPTOMS:

·         Determine exact time of onset of symptoms and document in medical record.

·         Activate the Acute Stroke Service via the ED’s Quickpage system by keying in "STROKE" followed by a message of notification informing of the patient’s age, exact time of onset, condition, any relevant history, and ETA.

·         Order STAT non-contrast head Ct. CT Scan will be read by a neurologist or radiologist.

·         Obtain blood samples for STAT CBC, electrolytes, BUN, creatinine, glucose, PT, PTT, INR, fibrinogen, type + hold. Hand write "STROKE STAT" on lab slips to expedite handling and processing for faster turn around time of lab results.

·         Obtain urine for b-HCG in all women of child-bearing age.

·         Obtain ECG and CXR.

·         Insert 2 large peripheral IV’s (18 gauge).

·         Notify nursing supervisor for ICU bed. ICU admission for monitoring for at least 24 hours.

·         If ICU bed is available, transfer patient and the Emergency Department’s "Acute Ischemic Clot Box" directly to the ICU immediately following CT Scan for administration of the drug.

·         If the ICU bed is not available, the patient should be returned from CT Scan to the ED for administration of the drug and later transferred to ICU bed for monitoring.

ADMINISTRATION OF TPA:

·         The Neurologist will check off all Inclusion and Exclusion Criteria on the Thrombolytic Check-List for Ischemic Stroke, sign it, and put in medical record.

·         Because of the risk of major bleeding, the risks and benefits of treatment should be discussed with the patient and/or family prior to administration of t-PA. Document the discussions.

·         Total t-PA dose = 0.9 mg/ kg (max 90 mg). 10% given as a bolus by the Neurologist or his representative over 60 seconds then the remaining infused over one hour. Example: A 100 kg patient would receive a 9mg bolus in the first minute followed by 81mg over the next hour. (See the tPA Dosing Chart)

Patient > 122 lbs (55.5kg): (100mg vial t-PA in "Acute Ischemic Clot Box")

·         Mix drug as follows: Transfer 100ml diluent into t-PA vial (100mg/vial) for total 100mg/100ml, or a 1:1 concentration. Swirl vial to mix, do not shake.

·         The bolus is drawn up out of bottle and injected over one minute.

·         The remaining dose can be hung directly and administered over one hour, via pump.

·         Follow t-PA infusion with normal saline via pump to infuse entire prescribed dose.

·         If t-PA is mixed and not used, return it to Pharmacy as there is a buy back policy and the drug will be replaced free of charge. Otherwise Discard any unused t-PA.

Patient < 122 lbs(55.5Kg): (50 mg vial t-PA in ED Pyxis)

·         Mix 50ml diluent into t-PA vial (50mg/vial) for total 50mg/ml, or a 1:1 concentration. Swirl vial to mix, do not shake.

·         The bolus is drawn up from the vial and administered over one minute.

·         Fill vacutainer (or empty 100ml NS bag) with the remaining dose to be administered over one hour, via pump.

·         Follow t-PA infusion with normal saline via pump to infuse entire prescribed dose.

Do not move patient until infusion is complete unless absolutely necessary and only as long as monitoring not interrupted.

·         Genentech, Inc. 1-800-821-8590

·         If Activase is mixed and then not used, return to Pharmacy as there is a buy back policy and the drug will be replaced free of charge.

MONITORING AND CARE DURING AND AFTER TPA INFUSION :

·         Vital signs and neuro checks:

·         Every 15 minutes for 2 hours after starting infusion.

·         Then every 30 minutes for 6 hours.

·         Then every 60 minutes until 24 hours after starting infusion.

·         Maintain SBP between 110 and 185mm Hg. See guidelines below.

·         Insertion of indwelling Foley catheter should be avoided during the infusion and for at least 30 minutes after infusion ends.

·         Insertion of a nasogastric tube should be avoided, if possible, during the first 24 hours.

·         Central venous access and arterial punctures should be avoided.

·         Intramuscular injections should be avoided.

·         NPO except meds for 24 hours.

·         Bed rest. 

·         Test all urine, stool, and emesis for occult blood.

·         Prophylactic H₂ blockers strongly recommended..

·         No anticoagulants should be administered for 24 hours (including ASA, NSAIDs).

·         After 24 hours, if anticoagulant or antiplatelet therapy is to be given, a follow up CT scan or MRI should be free of hemorrhage.

·         STAT Head CT for any worsening of neurologic condition

·         If hemorrhage is suspected, stop infusion of the thrombolytic drug.

·         Call HO, and send repeat CBC, platelet, INR, PTT, PT, fibrinogen, D-dimer.

·         STAT Head CT if ICH is suspected.

·         Prepare for administration of 6 to 8 units of cryoprecipitate containing factor VIII.

·         Prepare for administration of 6 to 8 units of platelets.

TREATMENT OF HYPERTENSION:

"Careful management of arterial blood pressure is critical during administration of TPA and the ensuing 24 hours. An excessively high blood pressure might predispose the patient to bleeding, while excessive lowering of blood pressure may worsen ischemic symptoms."

(Labetol 100mg in "Acute Ischemic Clot Box")

·         If SBP is >185 or if DBP is 110-139 for two or more readings 5-10 mins apart:

·         Give IV labetalol 10 mg over 1 - 2 minutes. The dose may be repeated or doubled every 10 - 20 minutes up to a dose of 150 mg.

·         Monitor BP every 15 minutes during labetalol treatment and observe for hypotension.

·         If no satisfactory response or if DBP >140 for two or more readings 5-10 mins apart:

·         Infuse sodium nitroprusside (0.5-10 mg/kg/minute).

·         Continuous arterial monitoring is advised if sodium nitroprusside is used. The risk of bleeding secondary to arterial puncture should be weighed against the possibility of missing dramatic changes in the BP during infusion.