Cooling Acute Ischemic Brain Damage - Safety and Feasibility Study "COOL AID I"

Completed

Phase N/A Results

Trial Description

To assess the safety and efficacy of induced endovascular hypothermia following acute ischemic stroke, and to gather data necessary to complete the design of a proposed large-scale efficacy trial.

Interventions

  • Hypothermia Device
    Intervention Desc: Reduction of brain temperature and body temperature for neuroprotection

Trial Design

Randomized, controlled, multicenter feasibility study.

Patient Involvement

Eligible patients will be randomized to receive either standard normothermic stroke treatment or standard care in conjunction with controlled moderate hypothermia. Patients in the hypothermic group will be cooled to a target temperature of 33º C using a heat-exchange catheter inserted into the inferior vena cava via the femoral vein. Hypothermia will be maintained for 24 hours, and then patients will be slowly rewarmed to 37º C.

Outcomes

Type Measure Time Frame Safety Issue
Primary Nature, severity and incidence of adverse events at 30 days, specifically, all mortality, all neurological, cardiac, vascular, hematological complications, and catheter/system complications, and ability of the SetPoint System to achieve and maintain the desired temperature profile.
Secondary Efficacy and patient tolerance of the shivering suppression protocol, final infarct volume, as measured by MRI

Sponsors

Radiant Medical Inc.