Nordic Cooling Stroke Study "NOCSS"

Terminated

Phase N/A Results N/A

Trial Description

To evaluate the safety and possible neuroprotective efficacy of induced mild hypothermia in non-anesthetized patients.

Interventions

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

Trial Design

Multecenter, multinational, randomized, controlled trial.

Patient Involvement

Patients randomized to the treatment groups will be cooled to 35 C over a period of 9 hours, using a surface cooling technique. Patients will receive meperidine to control shivering and discomfort. Patients will be passively rewarmed following the treatment period.

Outcomes

Type Measure Time Frame Safety Issue
Primary Mortality rate, SSS, NIHSS, MRS, BI, and SF-36 scores at 90 days.