Intravenous Thrombolysis Plus Hypothermia for Acute Treatment of Ischemic Stroke
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke; Hypothermia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to evaluate if it is safe to use tissue plasminogen activator
      (tPA) within 6 hours of stroke onset when combined with hypothermia.
    

Detailed description: 
      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, but not for those who arrive at the hospital more
      than 3 hours after 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. In particular, hypothermia may make it possible to use tPA later than 3
      hours after a stroke begins. This study will determine if it is safe to use tPA within 6
      hours of the start of a stroke when combined with hypothermia.

      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.

      Participants will be randomly assigned to a study group based on when their stroke began.
      Those who arrive at the hospital less than 3 hours from stroke onset will receive tPA alone
      or tPA with cooling (hypothermia). Those who arrive at the hospital 3 to 6 hours after stroke
      onset will be assigned to 1 of 4 groups-receiving either tPA alone, tPA with cooling, cooling
      alone, or standard medical care. 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.
    

Intervention name(s): hypothermia; tissue plasminogen activator
Intervention type(s): Procedure; Drug
Intervention description(s): Hypothermia with or without tPA for stroke. Hypothermia is induced using the Celsius Control™ System.
Subjects are stratified by time to six groups.; tPA is a naturally occurring protein that opens blocked arteries by dissolving blood clots
Intervention MeSH terms: Plasminogen; Tissue Plasminogen Activator
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stroke; hypothermia; cooling; tissue plasminogen activator; tPA; thrombolysis