Tissue Plasminogen Activator for Acute Ischemic Stroke (October 1996)

Purpose:
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.

Recommendations:
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.

1. Diagnosis is acute ischemic stroke.

2. There is a definite time of initial symptom onset.

3. Patient has a significant acute focal neurologic deficit.

4. Neurologist has been consulted (at least by telephone) and concurs with t-PA use. Neurology will participate in ongoing inpatient management.

5. 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.

1. 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.

2. 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.

3. CT scan shows any evidence of intracranial hemorrhage.

4. Significant spontaneous improvement of neurologic deficits prior to initiation of t-PA administration (includes TIAs).

5. Minor neurologic deficit, such as isolate sensory symptoms, isolated limb ataxia, or isolated mild limb weakness as the only clinical finding.

6. Suspected subarachnoid hemorrhage.

7. Common disorders mimicking stroke, such as:


• Seizure at the onset of stroke.
• Glucose concentrations below 50 mg/deciliter or above 400 mg/deciliter.

8. 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.

9. 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.