Acute Myocardial Infarction (the formulary thrombolytic for AMI at AAMC is TNK, please see the TNK monograph in this manual for information)

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1 ANNE ARUNDEL MEDICAL CENTER CRITICAL CARE MEDICATION MANUAL DEPARTMENT OF NURSING AND PHARMACY Guidelines for Use of Intravenous Alteplase (Tissue Plasminogen Activator (t-pa)), Activase in the Treatment of ACUTE ISCHEMIC STROKE Major Indications Acute Ischemic Stroke t-pa is indicated for the management of acute ischemic stroke in adults for improving neurological recovery and reducing the incidence of disability. Treatment should only be initiated within 3 hours after the onset of stroke symptoms (treatment within a hour window from onset is acceptable when applying additional exclusion criteria; see Patient Selection Guidelines for t-pa in Acute Ischemic Stroke below), and after the exclusion of intracranial hemorrhage by a cranial CT scan or other diagnostic imaging method sensitive for the presence of hemorrhage. Safety and efficacy of t-pa use in minor neurological deficit or rapidly improving symptoms has not been evaluated. Acute Myocardial Infarction (the formulary thrombolytic for AMI at AAMC is TNK, please see the TNK monograph in this manual for information) Pulmonary Embolism (see section in this manual titled Guidelines for Use of t-pa in the Treatment of Pulmonary Embolism) Mechanism of Action t-pa acts as a thrombolytic agent by promoting the direct conversion of plasminogen to plasmin which then acts directly on fibrin in clots to promote clot dissolution. Patient Selection Guidelines for t-pa in Acute Ischemic Stroke 1. t-pa could be used for treatment in patients with symptoms consistent with ischemic stroke with 0-3 hours who have: Diagnosis of ischemic stroke causing measurable neurologic deficit Neurologic signs should not be clearing spontaneously Neurologic signs should not be minor and isolated Caution should be exercised in treating patients with major deficits Symptoms should not be suggestive of subarachnoid hemorrhage Onset of symptoms < 3 hours before beginning treatment No head trauma or prior stroke in past 3 months No myocardial infarction in past 3 months No GI or GU hemorrhage in past 21 days No major surgery in past 14 days No arterial puncture at a non-compressible site in past 7 days No history of previous intracranial hemorrhage BP not elevated (SBP is < 185 mmhg, DBP is < 110 mmhg) No evidence of active bleed or acute trauma on exam Not taking oral anticoagulant or if taking, INR 1.7 If receiving heparin in previous 48 hours, aptt is in normal range Page 1 of 9 Updated Last: 11/16/2011

2 Platelets are > 100,000 Blood glucose is 50 mg/dl No seizure with post-ictal residual neurological impairment CT does not show a multilobar infarct (hypodensity > 1/3 cerebral hemisphere) Patient or family understand potential risks and benefits No contraindications to thrombolytic therapy (see below). Patients meeting these criteria who are >77 years old, have severe symptoms on admission (e.g. NIHSS > 22) or have major early findings on CT scan (edema, mass effect, midline shift ) are at greater risk for intracranial bleed, yet may be treated with t- PA if benefit outweighs risk. 2. t-pa could be used for treatment in patients with symptoms consistent with ischemic stroke within hours who have: Diagnosis of ischemic stroke causing measurable neurologic deficit Neurologic signs should not be clearing spontaneously Neurologic signs should not be minor and isolated Caution should be exercised in treating patients with major deficits Symptoms should not be suggestive of subarachnoid hemorrhage Onset of symptoms hours before beginning treatment No head trauma or prior stroke in past 3 months No myocardial infarction in past 3 months No GI or GU hemorrhage in past 21 days No major surgery in past 14 days No arterial puncture at a non-compressible site in past 7 days No history of previous intracranial hemorrhage BP not elevated (SBP is < 185 mmhg, DBP is < 110 mmhg) No evidence of active bleed or acute trauma on exam Not taking any oral anticoagulant Receiving heparin in previous 48 hrs Platelets are > 100,000 Blood glucose is 50 mg/dl No seizure with post-ictal residual neurological impairment CT does not show a multilobar infarct (hypodensity > 1/3 cerebral hemisphere) Patient or family understand potential risks and benefits No contraindications to thrombolytic therapy (see below) Age > 80 years Oral anticoagulation therapy( regardless of INR level) Baseline NIHSS > 25 History of both stroke and diabetes Contraindications for all patients Intracranial hemorrhage must be ruled out prior to t-pa therapy. History of intracranial hemorrhage. Clinical suspicion of subarachnoid hemorrhage (even if CT shows no bleed). Active internal bleeding. Recent intracranial surgery or head trauma or recent previous stroke Page 2 of 9 Updated Last: 11/16/2011

3 Severe uncontrolled hypertension (SBP >185 mmhg, DBP > 110 mmhg for 2 readings within 15 minutes) that does not respond to either: o Labetalol 10-20mg IV over 1-2 minutes times 2 doses ~OR~ o Nitroglycerine paste 1-2 inches topically ~OR~ o Nicardipine infusion (5 mg/hr, titrate by 2.5mg/hr q 5-15 minutes up to max 15 mg/hr, and decreased to 3 mg/hr when BP controlled) Seizure at time of stroke Intracranial neoplasm, arteriovenous malformation, or aneurysm. Known bleeding diathesis including o use of warfarin or INR > 1.7 or PT > 15 seconds o use of heparin within 48 hours prior to stroke and elevated aptt on presentation o platelet count < 100,000 Currently taking a direct thrombin inhibitor (i.e. digabatran (Pradaxa ) or rivaroxaban (Xarelto )) within the last 4 days. Precautions / Relative Contraindications for all patients Risk of bleeding may be increased in the Hepatic Dysfunction following situations: Pregnancy Recent major surgery (6 weeks) Hemorrhagic ophthalmic conditions Cerebrovascular disease Septic thrombophlebitis Recent GI or GU bleeds (6 months) Age > 77 years of age for 0-3 hour window Recent trauma (6 weeks) Age >80 years of age for hour window Hypertension (SBP 175, DBP >110) Oral anticoagulation (warfarin, digabatran Likelihood of left heart thrombus (Pradaxa ), or rivaroxaban (Xarelto )) Acute pericarditis Any condition where bleeding represents a Subacute bacterial endocarditis hazard or is at a difficult location to manage Hemostatic defects Adverse Reactions 1. Bleeding, both internal, including intracranial hemorrhage, and superficial. The risk of bleeding can be minimized by careful patient selection, following monitoring guidelines below, and using the nursing guidelines for the care of anticoagulated patients. 2. Cholesterol embolization 3. Phlebitis 4. Angioedema (may cause partial airway obstruction) Special Administration and Monitoring Guidelines for t-pa in Stroke 1. Proper patient selection is essential - see Patient Selection Guidelines and t-pa checklist. 2. Follow general nursing guidelines for care of the anticoagulated patient 3. Insert 2 x 20 gauge saline locks for rapid IV access. 4. Ensure baseline cranial CT scan & labs have been completed before starting t-pa. 5. ALL patients are individually dosed based upon weight - see preparation section for infusion protocol, rate, stability, etc. 6. Weight-dosing is based upon 0.9mg/kg total, with 10% of the dose given as a bolus over 1 minute, and the rest of the drug given over 60 minutes as an infusion - see preparation section. Page 3 of 9 Updated Last: 11/16/2011

4 Use 50 mg vials to get the appropriate dose for patients weighing <55.5 kg (122 lbs.) Use 100 mg vials to get the appropriate dose for patients >55.5 kg.(122 lbs.) 7. The maximum dose of t-pa when used for stroke is 90 mg, regardless of patient size. 8. t-pa infusion for stroke must be delivered via an infusion pump, and the must be validated by a second RN. 9. Monitor neurologic status and blood pressure (should be kept less than 180 mmhg systolic and 105 mmhg diastolic): q 15 minutes for 2 hrs, then q 30 minutes for 6 hrs, then q 1 hour during hours 8 through 24 after starting TPA infusion Management of elevated blood pressure during or after t-pa treatment: SBP is between mmhg OR DBP is between mmhg SBP is greater than 230 mmhg OR DBP is between mmhg If blood pressure is not controlled Give labetolol* 10 mg IV over 1-2 minutes. The dose may be repeated every minutes up to a 300mg max. cumulative dose ~OR~ Labetalol 10 mg IV over 1-2 minutes followed by an infusion at 2-8 mg/hr. Give labetolol* 10 mg IV over 1-2 minutes. The dose may be repeated every minutes up to a 300mg max. cumulative dose ~OR~ Labetalol 10 mg IV over 1-2 minutes followed by an infusion at 2-8 mg/hr. ~OR~ Nicardipine infusion 5mg/hr, titrate up to desired effect by increasing by 2.5 mg/hr every 5 minutes up to a maximum of 15 mg/hr. Begin nitroprusside infusion 0.5 to 10 mcg/kg/minute Monitor BP every 15 minutes Observe for hypotension. Avoid excessive reduction**. Consider holding TPA infusion until BP controlled Monitor BP every 10 minutes Observe for hypotension. Avoid excessive reduction**. Monitor BP every 15 minutes Observe for hypotension. Avoid excessive reduction**. *contraindicated in patients with bronchospastic disease/asthma - consider IV enalapril (Vasotec) instead **reduction faster than 5-10 mm Hg over 5-10 minutes should be avoided. 11. Stop t-pa infusion (if during administration) and notify physician immediately if any neurological deterioration or new-onset headache. 12. Notify physician immediately if hypertension, seizure, nausea, or vomiting. 13. Follow Algorithm for Management of Suspected Intracranial Hemorrhage (next page) if instructed by physician for suspected intracranial bleed. 14. Hold t-pa and notify physician if evidence of any other serious bleeding. 15. Anticoagulants (enoxaparin, heparin or warfarin) or antiplatelet agents (aspirin, ticlopidine, clopidogrel, dipyridamole) must be avoided during the 24 hour period following t-pa infusion for stroke. 16. Venipuncture, if needed, should be done with as 22 or 23 gauge needle; compress all venipuncture sites for at least 10 minutes. 17. NO arterial punctures, invasive procedures, intramuscular injections, or puncture of noncompressible vessels for the first 24 hours following t-pa infusion. Page 4 of 9 Updated Last: 11/16/2011

5 18. NO foley catheter or nasogastric tube placement. Comments 1. t-pa for stroke is available from Pharmacy please call to alert the pharmacy (x4155). 2. Neurologic and functional assessments must be done according to the pathway schedule. This is essential to the clinical management of the patients as well as outcomes measurements. Algorithm for Management of Suspected Intracranial Hemorrhage Note 1: Stopping t-pa is not mandatory if other causes of neurologic deterioration are apparent, however CT scan is required in all cases to rule out intracranial hemorrhage. Note 2: Preparations for giving platelets and fibrinogen should be made at the first suspicion of hemorrhage so that they are ready if needed. Page 5 of 9 Updated Last: 11/16/2011

6 Preparation Sheet Alteplase Infusion for Acute Ischemic Stroke 1. Alert Pharmacy regarding potential t-pa patient (x4155), pharmacy will mix t-pa when order is received and will deliver dose to the bedside. For patients weighing < 55.5 kg (122 lbs.) expect a 50 mg sized vial and for patients weighing > 55.5 kg (122 lbs.) expect a 100mg sized vial. 2. Validate the amount of alteplase to be administered to the patient via dosing chart below. 3. Obtain dual nurse sign off of bolus and infusion. 4. Deliver bolus dose IV Push over 1 minute. 5. Spike vial with infusion set. Open vent and prime tubing. 6. Insert cassette into infusion pump. 7. INFUSION: a. Select Line A b. Select drug list c. Select Alteplase STROKE inf press enter d. Select standard program press choose e. Enter dose (mg/hr) and VTBI in ml (the dose and the VTBI will be the same number since it is a 1:1 concentration) f. The duration and rate will automatically calculate (1 hour) g. Press start and confirm h. Once the infusion is complete then the pump will alarm and will go to KVO 8. NS 50 ml FLUSH: a. Press Stop b. Select Line A c. Select Yes when it asks Clear Line A Settings d. Select drug list e. Select IV FLUID press enter f. Select standard program press choose g. Enter the same rate that the 1 hour TPA infusion was h. Enter 50 ml for the VTBI i. Press start and confirm Note: 9. You no longer need a vented spike adapter open the vent on the IV tubing when the t-pa bottle is hung, then close the vent on the tubing when the NS flush bag is hung. 10. Upon completion of t-pa infusion before drip chamber empties, remove t-pa vial from tubing set, and using the same tubing, spike and attach a 50 ml bag of Normal Saline. Infuse the saline bag at the same rate as the one hour t-pa infusion (purpose is to flush residual t-pa through tubing so that patient receives the complete dose). The normal saline infusion can be stopped after 30 minutes. Page 6 of 9 Updated Last: 11/16/2011

7 Dose by Weight for t-pa in Acute Ischemic Stroke Waste amount will be withdrawn by pharmacy and will be noted on label Patient Weight Total Dose Bolus Dose Infusion Dose Waste Amount Lbs Kg mg=ml mg=ml mg=ml mg=ml Page 7 of 9 Updated Last: 11/16/2011

8 Patient Weight Total Dose Bolus Dose Infusion Dose Waste Amount Lbs Kg mg=ml mg=ml mg=ml mg=ml Page 8 of 9 Updated Last: 11/16/2011

9 Patient Weight Total Dose Bolus Dose Infusion Dose Waste Amount Lbs Kg mg=ml mg=ml mg=ml mg=ml >220 > Page 9 of 9 Updated Last: 11/16/2011

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