Hypothermia in Acute Ischemic Stroke: Surface versus Endovascular cooling "HAIS-SE"

Recruiting

Phase N/A Results

Trial Description

To evaluate feasibility, tolerability and safety of surface cooling (CSZ Blanketrol III) versus endovascular cooling (Zoll Thermogard XP) in awake patients with acute ischemic stroke plus acute stroke treatment including thrombolysis.

Interventions

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

Trial Design

Prospective, open, randomized, controlled single-centre study (n=60).

Patient Involvement

Hypothermia-induction (cold infusions) starts simultaneously with rt-PA. Surface cooling starts as soon as possible, catheter placement for endovascular cooling is performed 30min after the end of rt-PA-infusion. The intended body core temperature is 34°C. Hypothermia will be maintained for 12h, 18h or 24h depending on detectable vessel occlusion (CTA or TCD) at 0h, 6h or 12h, followed by controlled re-warming (0,2°C/h).The controls receive standard stroke treatment (ESO guidelines).

Outcomes

Type Measure Time Frame Safety Issue
Primary Time to 35°C body core temperature.
Secondary Incidence of (treatment related) adverse events, treatment tolerability, temperature stability and cerebral auto-regulation.

Sponsors

none