Safety of Intravenous Thrombolytics in Stroke on Awakening (SAIL-ON)
|ClinicalTrials.gov Identifier: NCT01643902|
Recruitment Status : Completed
First Posted : July 18, 2012
Results First Posted : April 17, 2017
Last Update Posted : April 17, 2017
The primary objective of this study is to evaluate the safety of intravenous tissue plasminogen activator (IV tPA) in patients waking up with symptoms of acute stroke and presenting to the Emergency Department (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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Drug: tPA||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety of Intravenous Thrombolytics in Stroke on Awakening|
|Study Start Date :||January 2013|
|Primary Completion Date :||December 2015|
|Study Completion Date :||December 2015|
Experimental: IV tPA
Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria
IV tPA 0.9 mg/kg maximum 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 door to needle time of 60 minutes or less from ED arrival.
- Number of Participants With Symptomatic Intracerebral Hemorrhage Within 36 Hours of Treatment [ Time Frame: within 36 hours of treatment ]
Symptomatic intracerebral hemorrhage by using the European Cooperative Acute Stroke Study (ECASS) 3 criteria as well as the original National Institutes of Neurological Disorders and Stroke (NINDS) Intravenous tissue plasminogen activator (IV tPA) trial criteria for comparison.
ECASS 3 criteria: hemorrhage in brain imaging, and an increase of 4 or more points on the National Institutes of Health Stroke Scale (NIHSS) from baseline.
NINDS IV tPA trial criteria: a hemorrhage not seen in previous brain imaging, associated with a neurological decline attributable to the hemorrhage.
- Functional Outcome by the Modified Rankin Scale at 90 Days [ Time Frame: 90 days ]
The modified Rankin scale (mRS) is a scale of disability after stroke, with a range of 0 to 6.
0, no symptoms at all.
- no significant disability despite symptoms; able to carry out all usual duties and activities.
- slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance.
- moderate disability; requiring some help, but able to walk without assistance.
- moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance.
- severe disability; bedridden, incontinent and requiring constant nursing care and attention.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643902
|United States, Maryland|
|Johns Hopkins Bayview Medical Center|
|Baltimore, Maryland, United States, 21224|
|The Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Victor C Urrutia, MD||Johns Hopkins University|