Safety of Intravenous Thrombolysis for Wake-up Stroke (Wake-Up Stroke)
The purpose is to demonstrate the safety of IV t-PA in ischemic stroke patients who present to the ED after awakening with the symptoms of suspected ischemic stroke.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety of Intravenous Thrombolysis for Wake-up Stroke|
- Frequency of symptomatic hemorrhagic transformation Safety of iv t-PA in wake up stroke patients [ Time Frame: 24 hr ] [ Designated as safety issue: Yes ]The primary outcome of this study is the frequency of symptomatic hemorrhagic transformation evident within 24 hours of treatment with IV t-PA.
- Clinical improvement [ Time Frame: up to 90 days ] [ Designated as safety issue: No ]Clinical improvement defined as a decrease in the NIHSS score at 24 hours, 3 days and 90 days and modified Rankin at 3 days and 90 days.
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
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.
This is an open label, multi-center, safety study of acute treatment with IV alteplase in ischemic stroke patients who wake-up with their symptoms. The primary outcome of this study is the frequency of symptomatic hemorrhagic transformation evident within 24 hours of treatment with IV t-PA. Clinical improvement defined as a decrease in the NIHSS score at 24 hours, 3 days and 90 days and modified Rankin at 3 days and 90 days. For patients that have CTA and CTP, the incidence of large vessel occlusion will be quantified.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01183533
|Contact: Jennifer M Garrett, RNfirstname.lastname@example.org|
|United States, Alabama|
|University of Alabama||Recruiting|
|Birmingham, Alabama, United States, 35233|
|Contact: Andre Alexandrov, MD|
|Principal Investigator: Andre Alexandrov, MD|
|United States, Colorado|
|Swedish Medical Center||Recruiting|
|Englewood, Colorado, United States, 80113|
|Contact: Chris Fanale, MD|
|Principal Investigator: Chris Fanale, MD|
|United States, Texas|
|UT-Houston Health Science Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Jennifer M Garrett, RN 713-500-7183 email@example.com|
|Principal Investigator: Sean I Savitz, MD|
|Sub-Investigator: Andrew Barreto, MD|
|Principal Investigator:||Sean I Savitz, MD||UT-Houston Health Science Center|
|Principal Investigator:||Andrew Barreto, MD||Study Co-PI|