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

HAIS-SE (Hypothermia in Acute Ischemic Stroke - Surface Versus Endovascular Cooling): A Randomized Trial Comparing Surface Versus Endovascular Cooling in Awake Stroke Patients Treated With Thrombolysis

HAIS-SE is evaluating for the first time ever in a randomized controlled trial efficacy, tolerability, practicability and safety of endovascular versus surface cooling in awake stroke patients.

Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac arrest. Via animal models hypothermia has been identified as the most promising neuroprotective therapy in focal cerebral ischemia as well. But the prove of clinical benefit in patients with acute ischemic stroke is still missing: Most likely due to the prolonged time window until hypothermia-induction (14 h) in previous studies. In addition, feasibility of the method through which hypothermia is applied is crucial for a broad implementation of hypothermia in stroke therapy. Surface versus endovascular cooling have never been compared in a prospective trial in awake stroke patients.

HAIS-SE is evaluating for the first time ever in a randomized controlled trial efficacy, tolerability, practicability and safety of endovascular versus surface cooling in awake stroke patients.

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