Safety of Intravenous Thrombolytics in Stroke on Awakening (SAIL-ON)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety of Intravenous Thrombolytics in Stroke on Awakening|
- symptomatic intracerebral hemorrhage [ Time Frame: within 36 hours of treatment ] [ Designated as safety issue: Yes ]Data on symptomatic intracerebral hemorrhage by using the ECASS 3 criteria as well as the original NINDS IV rt-PA trial criteria for comparison.
- Functional outcome. [ Time Frame: 90 days ] [ Designated as safety issue: No ]Evaluate mRankin score, NIHSS, Barthel index at 90 days. (NIHSS also collected at 24 hours)
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: IV rt-PA
Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria
IV rt-PA 0.9 mg/kg minimum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target foor to needle time of 60 minutes or less from ED arrival.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643902
|Contact: Victor C Urrutia, MDfirstname.lastname@example.org|
|Contact: Susan Rice, RNemail@example.com|
|United States, Maryland|
|Anne Arundel Medical Center||Recruiting|
|Annapolis, Maryland, United States|
|Contact: Alexander Katcheves, MD|
|Principal Investigator: Alexander Katcheves, MD|
|Johns Hopkins Bayview Medical Center||Recruiting|
|Baltimore, Maryland, United States|
|Contact: Rafael Llinas, MD|
|Principal Investigator: Rafael Llinas, MD|
|The Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator: Victor C. Urrutia, MD|
|Principal Investigator:||Victor C Urrutia, MD||Johns Hopkins University|