Hypothermia in Acute Ischemic Stroke - Surface Versus Endovascular Cooling (HAIS-SE) "HAIS-SE"

Active, not recruiting

Phase 2 Results N/A

Eligibility Criteria

Inclusion Criteria

- Ischemic stroke
- Intravenous thrombolysis within 4.5h from symptom onset
- Informed consent of the patient
- NIHSS score ≥ 2 and ≤ 20
- Age ≥ 18 and ≤ 90 years
- Placement of cooling catheter / cooling pads within 6h from symptom onset

Exclusion Criteria

- (Expected) intubation (e.g. for interventional treatment)
- Pregnancy
- Body weight > 120kg
- Body height < 150cm
- Life-expectancy < 3 months
- Fever > 38.5°C at screening
- Known hematologic disease with increased risk of thrombosis (e.g. cryoglobulinemia, cold agglutinins, sickle cell anemia)
- Known vasospastic vascular disorder (e.g. Raynaud's phenomenon or thromboangiitis obliterans)
- Possible compression of the inferior vena cava (e.g. due to tumor) or vena cava filter
- Acute pulmonary embolism
- Acute myocardial infarction
- Severe cardiac insufficiency (NYHA ≥ III)
- Threatening ventricular dysrhythmia
- QTc-interval > 450ms
- Bradycardia < 50/min
- Sick-Sinus-Syndrom
- AV-block > I°
- Severe infection with bacteremia or sepsis ≤ 72h
- Severe renal (GFR < 30ml/min) or liver insufficiency (Child-Pugh C)
- Myopathy
- Known intolerance or allergy against acetaminophen, buspirone, clonidine, magnesium sulphate or pethidine.
- Treatment with MAO-inhibitors ≤ 14 days
- Acute closed-angle glaucoma