Safety of Intravenous Thrombolytics in Stroke on Awakening
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | January 2013 |
| End Date: | December 2014 |
| Contact: | Victor C Urrutia, MD |
| Email: | vurruti1@jhmi.edu |
| Phone: | 4109552228 |
The primary objective of this study is to evaluate the safety of intravenous tPA in patients
waking up with symptoms of acute stroke and presenting to the ED within 4.5 hours from
awakening, and meeting standard criteria for treatment with IV tPA for acute stroke.
The hypothesis is that patients that wake up with stroke symptoms may have developed the
stroke at the time of awakening, and may be within the 4.5 hour window if they arrive to the
ED within that time, therefore IV tPA should be safe and effective in this population.
waking up with symptoms of acute stroke and presenting to the ED within 4.5 hours from
awakening, and meeting standard criteria for treatment with IV tPA for acute stroke.
The hypothesis is that patients that wake up with stroke symptoms may have developed the
stroke at the time of awakening, and may be within the 4.5 hour window if they arrive to the
ED within that time, therefore IV tPA should be safe and effective in this population.
Inclusion Criteria:
- Age greater or equal to 18 years.
- Signs and symptoms of acute ischemic stroke.
- Symptoms present upon awakening.
- Arriving to the Emergency Department within 4.5 hours of awakening. Treatment with IV
rt-PA must be initiated prior to 4.5hours from waking up.
- NIHSS >3
- A non-contrast head CT without hemorrhage and without hypodensity more than 1/3 of
the MCA territory; or MRI demonstrating no hemorrhage, and with a DWI lesion no
greater than 70mL and FLAIR without a well defined hyperintense lesion that is more
than 1/3 of the MCA territory.
- Pre-morbid modified Rankin score of 0 or 1.
Exclusion Criteria:
- Rapidly improving deficit to an NIHSS less than 3.
- Sustained systolic blood pressure greater than 185mmHg or diastolic blood pressure
greater than 110mmHg despite treatment.
- Glucose less than 50mg/dL.
- Stroke or head trauma within last 3 months.
- History of intracranial hemorrhage. Symptoms of subarachnoid hemorrhage.
- Major surgery within 14 days.
- GI/GU hemorrhage within 21 days.
- INR > 1.7.
- Heparin within 48 hours with an elevated aPTT.
- Platelet count less than 100,000.
- Presumed septic embolus or suspicion of bacterial endocarditis.
- Suspicion of aortic dissection.
- Use of anticoagulants such as dabigatran, rivaroxaban, apixaban, enoxaparin.
- Pregnant or lactating women.
- Known allergy or sensitivity to rt-PA.
We found this trial at
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Johns Hopkins Bayview Medical Center There is no better story in American medicine in the...
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