To provide initial safety and feasibility data regarding mild hypothermia (35°C) in an acute ischemic strokepatient population using non-invasive temperature management system.
- Hypothermia Device
Intervention Desc: Reduction of brain temperature and body temperature for neuroprotection
Prospective, open, randomized single-centre study.
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.
|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.|