Mild Hypothermia in Acute Ischemic Stroke: Safety and Feasibility Study

Active, not recruiting

Phase N/A Results N/A

Trial Description

To provide initial safety and feasibility data regarding mild hypothermia (35°C) in an acute ischemic strokepatient population using non-invasive temperature management system.

Interventions

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

Trial Design

Prospective, open, randomized single-centre study.

Patient Involvement

Patients randomized to hypothermia treatment will be cooled to the core temperature of 35°C (urinary bladder temperature) with non-invasive Temperature Management System within 6 hours of symptom onset. Patients will be breathing spontaneously, and shivering will be controlled with medication. The slow rewarming (0.2°C/hour) will be started after 12 hours of successful cooling. Patients will also be evaluated by BI, NIHSS, GOS, size of infarction in MRI, and the neuropsychological outcome at 3 months.

Outcomes

Type Measure Time Frame Safety Issue
Primary Proportion of patients who maintain temperature below 36,0°C 80% of the 12-hour study period.
Secondary Safety objectives are the incidence of intracerebral hemorrhage, infections, hemodynamically significant cardiac arrhythmias, severe disturbance of electrolytes and fluid balance, thrombocytopenia, and serious adverse events until discharge or 14 days; all-cause mortality during acute phase (7 days), 1-month, and 3-month follow-up; and readmission to hospital for any reason within the 3-month follow-up period. Feasibility objective is to assess tolerance to and the effectiveness of the shivering suppression protocol, the effectiveness of non- invasive temperature management system in non- intubated patients in achieving and maintaining the desired core temperature, and the feasibility of non- invasive temperature management system in acute stroke unit environment. Efficacy objectives are the proportion of modified Rankin scale (mRS)- responders (defined as a subject with mRS 0-2), the scoring of BI, NIHSS, GOS and neuropsychological outcome at 3 months, and the size of infarction in MRI and the rate and extent of hemorrhagic transformation when comparing hypothermia-group to control-group.