The Intravascular Cooling in the Treatment of Stroke 2/3 Trial (ICTuS2/3)
|Stroke, Acute||Device: hypothermia and anti-shivering treatment Drug: Group1: IV t-PA and normothermia||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
Randomized to normothermia or hypothermiaMasking: Outcomes Assessor
Primary Purpose: Treatment
|Official Title:||Phase 2/3 Study of Intravenous Thrombolysis and Hypothermia for Acute Treatment of Ischemic Stroke|
- The Primary Outcome is the Proportion of Patients Achieving a Favorable Outcome Defined as Modified Rankin Scale Score of 0 or 1, Assessed 90 Days After Treatment. [ Time Frame: 90 days ]Modified Rankin describes disability: 0 is free of any disability or symptoms, 6 is death, and higher grades between 0 and 6 reflect progressively greater disability
- Incidence of Any Intracranial Hemorrhage (ICH) Within 48 Hours of Stroke Onset [ Time Frame: 48 hours ]Incidence (number) of any intracranial hemorrhage (ICH) (whether or not symptomatic) within 48 hours of stroke onset will be presented by treatment group and overall.
- Incidence of Any Symptomatic Intracranial Hemorrhage (sICH) Within 48 Hours of Stroke Onset [ Time Frame: 48 hours ]Incidence (number) of Symptomatic ICH (sICH) within 48 hours of stroke onset will be presented by treatment group and overall. Patients with neuroworsening (4 or more point increase in NIHSS , or a decline in the NIHSS consciousness item 1A score of more than 1 point, or a motor deterioration lasting more than 8 hours, all not due to iatrogenic cause) and hemorrhage seen on brain images in whom the investigator attributes the clinical change to the hemorrhage.
- Incidence of Pneumonia [ Time Frame: 7 days or discharge whichever comes first ]Number subjects diagnosed with pneumonia according to CDC criteria will be presented by treatment group and overall, regardless of seriousness
- 90 Day Mortality [ Time Frame: 90 days ]Mortality prior to the 90-day evaluation.
- The Barthel Index Measure of Activities of Daily Living; [ Time Frame: 90 days ]The Barthel index measures independence in activities of daily living from 0 (worst) to 100 (best) in 5 point increments. Higher scores between 0 and 100 reflect progressively greater levels of independence. Scores were dichotomized at 90 so that a score of 95 or 100 was considered a successful treatment.
- NIHSS Scores at 90 Days [ Time Frame: 90 days ]The National Institutes of Health Stroke Scale (NIHSS) is used to quantify neurological deficit. The scale ranges from 0 (best) to 42 points (worst). Between scores of 0 to 42, higher values reflect progressively greater deficit.
|Study Start Date:||June 2010|
|Study Completion Date:||May 2015|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Group1: IV t-PA and normothermia
IV tpa and normothermia
Drug: Group1: IV t-PA and normothermia
Group 1 will t-PA as standard of care and normothermia
Active Comparator: Group 2 : IV t-PA and hypothermia and anti-shivering treatment
IV tpa and hypothermia and anti-shivering treatment
Device: hypothermia and anti-shivering treatment
Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine and surface warming
Other Name: cooling
A stroke is usually caused by a blockage in one of the arteries that carries blood to the brain. Research has shown that tissue plasminogen activator (tPA)—a naturally occurring protein that opens blocked arteries by dissolving blood clots — activates the body's ability to dissolve recently formed blood clots and reduces or prevents the brain damage caused by a stroke.
The Food and Drug Administration (FDA) has approved the use of tPA for people having a stroke when taken within 3 hours of stroke onset.
Researchers believe that a lower body temperature (hypothermia) may be beneficial while a stroke is happening because hypothermia may prevent further brain injury, or may make the stroke less damaging.
Patients will receive a standard stroke evaluation, which includes blood tests, a computed tomography (CT) scan, complete physical and neurological examinations, and an electrocardiogram (EKG) to determine eligibility for the study.
There are two study groups - tPA alone or tPA with cooling (hypothermia). Participants will be randomly assigned to one of the two study groups. Length of participation (including observation after the patient leaves the hospital) is 90 days.
This study is part of the Specialized Program of Translational Research in Acute Stroke (SPOTRIAS), which allows researchers to enhance and initiate translational research that ultimately will benefit stroke patients by treating more patients in less than 2 hours, and finding ways to treat additional patients later.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01123161
Show 31 Study Locations
|Principal Investigator:||Patrick D. Lyden, MD||Cedars-Sinai Medical Center|
|Study Director:||Thomas M. Hemmen, MD, PhD||University of California, San Diego|
|Study Director:||James C. Grotta, MD||The University of Texas Health Science Center, Houston|