Cooling Acute Ischemic Brain Damage - Pilot "COOL AID Pilot"

Completed

Phase N/A Results

Trial Description

To assess the safety and feasibility of induced moderate hypothermia as an adjunct to thrombolysis in patients with acute ischemic stroke.

Interventions

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

Trial Design

Controlled pilot study of 19 patients.

Patient Involvement

Eligible patients for whom hypothermia was feasible were cooled to a target temperature of 32ยบ C using cold-air blankets and alcohol rub-downs. Hypothermic patients were endotracheally intubated and infused with atracurium, a muscle relaxant, and propofol, a sedative, to suppress shivering, minimize discomfort, and ensure adequate ventilation. Hypothermia was maintained for 12-72 hours, depending on the degree of arterial blockage. Core body temperature was measured every 30 minutes by thermistor Foley catheter. All patients were slowly rewarmed to normal body temperature.

Eligible patients for whom hypothermia was logistically impossible were used as normothermic controls.

All patients received pre-treatment and post-treatment angiograms, CT scans at 24 hours and 7-10 days, and transcranial Doppler (TCD) sonography was performed daily. Blood tests, urinalyses, and chest radiographies were also performed. Patients were followed-up by a clinician at 3 months post-stroke.

Outcomes

Type Measure Time Frame Safety Issue
Primary Proportion of bad outcomes (MRS score 3 - 6) and good outcomes (MRS score 0-2) at 3 months, incidence of any adverse events.
Secondary Ability to reach and maintain target core temperature, infarct volume at 7-10 days, as measured by CT.

Sponsors

The Cleveland Clinic Foundation