Safety of Intravenous Thrombolysis for Wake-up Stroke (Wake-Up Stroke)
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|ClinicalTrials.gov Identifier: NCT01183533|
Recruitment Status : Completed
First Posted : August 17, 2010
Results First Posted : November 25, 2014
Last Update Posted : November 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke||Drug: Alteplase (iv t-PA)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety of Intravenous Thrombolysis for Wake-up Stroke|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||January 2014|
Experimental: off label rt-PA used
off label rt-PA used on all subject enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.
Drug: Alteplase (iv t-PA)
0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour.
- Frequency of Symptomatic Hemorrhagic Transformation Safety of iv Rt-PA in Wake up Stroke Patients [ Time Frame: 24 hours ]The primary outcome of this study is the frequency of symptomatic hemorrhagic transformation evident within 24 hours of treatment with IV t-PA. Symptomatic was defined as significant clinical deterioration with at least a 4 point or more increase in the NIH Stroke scale.
- 90-day Modified Rankin Scale (mRS) Score 0 or 1 [ Time Frame: 90 days ]Number of patients with mRS of 0 or 1 at 90 days. The mRS is a clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It has a minimum of 0 and a maximum of 6. Zero represents a patient that has no disability or residual stroke symptoms. A score of 1 is defined as: no significant disability: despite symptoms, able to carry out all usual duties and activities. The maximum score, 6, indicates death. A score of 2 is defined as slight disability: unable to perform all previous activities but able to look after own affairs without assistance; a score of 3 is defined as moderate disability: requiring some help but able to walk without assistance; a score of 4 is moderately severe disability: unable to walk without assistance and unable to attend to own bodily needs without assistance; a score of 5 is severe disability: bedridden, incontinent and requiring constant nursing care and attention.
- Mortality [ Time Frame: 90 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01183533
|United States, Alabama|
|University of Alabama|
|Birmingham, Alabama, United States, 35233|
|United States, Colorado|
|Swedish Medical Center|
|Englewood, Colorado, United States, 80113|
|United States, Texas|
|UT-Houston Health Science Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Sean I Savitz, MD||UT-Houston Health Science Center|
|Principal Investigator:||Andrew D Barreto, MD||Study Co-PI|