Cooling Helmet for Patients with Brain Ischemic and Hemorrhagic Infarctions "COOL BRAIN-STROKE"

Completed

Phase N/A Results

Trial Description

To investigate the safety and tolerability of a cooling helmet worn by acute stroke patients in a pre-hospital setting.

Interventions

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

Trial Design

Prospective, non-randomized pilot trial.

Patient Involvement

Patients who meet the enrollment criteria and agree to participate will have the cooling helmet put into place immediately by the emergency personnel. All patients will then be transported to the hospital, where they will all receive standard care according to the severity of their strokes. The helmet will remain on for 72 hours, and vital signs and any complications will be monitored frequently during that interval.

Outcomes

Type Measure Time Frame Safety Issue
Primary The safety of the helmet, as defined with respect to the incidence and severity of complications, and its efficacy in reducing the neurological damage of stroke, as defined with respect to the NIH Stroke Scale (NIHSS), the modified Rankin scale (MRS), and the Barthel index (BI)
Secondary To determine the degree of hypothermia that was achieved, and the extent of any morbidity and mortality associated with this therapy.