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

Recruiting

Phase N/A Results N/A

Trial Description

Evaluation of feasibility, tolerability and safety of surface versus endovascular cooling in awake stroke patients.

Interventions

  • 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

Trial Design

Prospective, randomized, controlled trial.

Patient Involvement

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).

Outcomes

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.

Sponsors

none