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.
- Hypothermia Device
Intervention Desc: Reduction of brain temperature and body temperature for neuroprotection
Prospective, open, randomized, controlled single-centre study (n=60).
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).
|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.|