Evaluation of feasibility, tolerability and safety of surface versus endovascular cooling in awake stroke patients.
- Tissue plasminogen activator (Activase®)Drug
Other Names: Alteplase; tPA Intervention Desc: Thrombolytic
- Hypothermia Device
Intervention Desc: Reduction of brain temperature and body temperature for neuroprotection
Prospective, randomized, controlled trial.
Hypothermia-induction 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).
|Type||Measure||Time Frame||Safety Issue|
|Primary||Time to 35°C body core temperature after hypothermia-induction.|
|Secondary||Incidence of (treatment related) adverse events, treatment tolerability and temperature stability.|