Controlled Hypothermia in Large Infarction "CHILI"

Recruiting

Phase N/A Results N/A

Trial Description

To determine the safety and efficacy of mild to moderate hypothermia using an external cooling method for neuroprotection following ischemic stroke.

Interventions

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

Trial Design

Multicenter trial

Patient Involvement

Hypothermia is initiated with the Arctic Sun cooling device until the patients' temperature reaches 35.0 degrees C for 48 hours. Controlled rewarming will increase body temperature by 0.5 degrees C every 12 hours until 37.0 degrees is achieved.

Outcomes

Type Measure Time Frame Safety Issue
Primary Time to reach hypothermia, effectiveness in maintaining hypothermia, NIHSS, GCS, Rankin and Barthel, mortality, discharge location, ICU length of stay, and radiographic changes.

Sponsors

Medivance