Tissue Plasminogen Activator for Acute Ischemic Stroke (October 1996)
Tissue plasminogen activator (t-PA) may play a role in minimizing damage from acute ischemic stroke and preserving functional status in selected patients. The purposes of this guideline are to:
- Provide a framework for the treatment of ischemic stroke with t-PA in appropriate patients;
- Provide appropriate rigorous exclusion criteria to minimize risk associated with t-PA use.
The NINDS study has shown that t-PA to be effective in the treatmentof acute stroke for a select group of patients, if initiated within three hours of initialsymptom onset. The FDA has approved t-PA for this indication. The benefit of treatmentwith t-PA has been demonstrated to outweigh the attendant risk only in patients who meetrigorous inclusion and exclusion criteria. Patients not qualifying by the followingcriteria should not be treated with t-PA. (Research Evidence: Grade A)
Whenever possible, the risks versus potential benefit of the use of t-PA should be discussed with the patient and family before treatment is initiated. Documentation of this discussion is recommended.
Inclusion Criteria for t-PA in Acute Stroke:
All of the following inclusion criteria should be met; treatment should be initiated within three hours of the initial onset of stroke symptoms.
- Diagnosis is acute ischemic stroke.
- There is a definite time of initial symptom onset.
- Patient has a significant acute focal neurologic deficit.
- Neurologist has been consulted (at least by telephone) and concurs with t-PA use. Neurology will participate in ongoing inpatient management.
- CT scan has been obtained and interpreted by an experienced physician.
Exclusion Criteria for t-PA in Acute Stroke:
Patients with any of the following conditions should not be treated with t-PA.
- Time of onset of stroke symptoms is unknown or unclear (includes patients waking from sleep with symptoms), or more than three hours has elapsed since initial symptom onset.
- Sustained blood pressure greater than 185/110 at time t-PA treatment is to be initiated. Treatment of blood pressure to attain this level is not recommended without prior discussion with neurology.
- CT scan shows any evidence of intracranial hemorrhage.
- Significant spontaneous improvement of neurologic deficits prior to initiation of t-PA administration (includes TIAs).
- Minor neurologic deficit, such as isolate sensory symptoms, isolated limb ataxia, or isolated mild limb weakness as the only clinical finding.
- Suspected subarachnoid hemorrhage.
- Common disorders mimicking stroke, such as:
- Seizure at the onset of stroke.
- Glucose concentrations below 50 mg/deciliter or above 400 mg/deciliter.
- Any other contraindication to t-PA including:
- Active internal bleeding.
- History of intracranial hemorrhage.
- Prior stroke within previous three months.
- Recent myocardial infarction.
- Serious head trauma within previous three months.
- GI or GU hemorrhage within previous 21 days.
- Major surgery within previous 14 days.
- Arterial puncture at a noncompressible site within previous seven days.
- Ongoing anticoagulant therapy at the time of stroke onset. (Antiplatelet therapy is NOT an exclusion criterion.)
- Heparin within 48 hours preceding onset of stroke, if associated with an elevated partial-thromboplastin time (PTT).
- Prothrombin time (PT) > 15 seconds. (Treatment need not be delayed for the results of PT if patient not recently on oral anticoagulants or suspected of having a coagulopathy.)
- Platelet count below 100,000/cubic millimeter.
- Any condition or circumstance in which the treating physician assesses that t-PA treatment would pose a significant hazard, e.g., end-stage organ failure, endocardidtis, other serious underlying medical condition, or intracranial lesion predisposing to intracerebral hemorrhage such as aneurysm, vascular malformation, or neoplasm.