Conditions: Stroke, Acute
Keywords: Hypothermia Molecular Mechanisms of Pharmacological Action Cerebral Infarction Hematologic Agents Stroke Nervous System Diseases Vascular Diseases Tissue Plasminogen Activator Central Nervous System Diseases Fibrinolytic Agents Cardiovascular Agents Body Temperature Changes Brain Diseases Cerebrovascular Disorders Pharmacologic Actions Signs and Symptoms Fibrin Modulating Agents Therapeutic Uses Brain Ischemia Cardiovascular Diseases Brain Infarction Plasminogen cooling tPA thrombolysis
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 120
Healthy volunteers: no

Brief summary:
The purpose of this trial is to determine whether the combination of thrombolysis and hypothermia is superior to thrombolysis alone for the treatment of acute ischemic stroke.

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.

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.

Arms:
arm 1: IV tpa and normothermia arm 2: IV tpa and hypothermia and anti-shivering treatment

Interventions: intervention 1: hypothermia and anti-shivering treatment intervention 2: Group1: IV t-PA and normothermia
Intervention descriptions: intervention 1: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine and surface warming intervention 2: Group 1 will t-PA as standard of care and normothermia

Protocol document: