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

University Hospital Heidelberg

Status and phase: Unknown; Phase 2

Conditions: Ischemic Stroke; Thrombolysis; Hypothermia

Treatments: Device: ZOLL Thermogard XP; Device: BARD/Medivance Arctic Sun 5000

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01665885

HAIS-SE

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Endovascular cooling

Active Comparator group

Description:

Endovascular cooling using the cooling device ZOLL Thermogard XP with ZOLL Quattro cooling catheter

Treatment:

Device: ZOLL Thermogard XP

Surface cooling

Active Comparator group

Description:

Surface cooling using the cooling device BARD/Medivance Arctic Sun 5000 with BARD/Medivance Arctic Gel Pads

Treatment:

Device: BARD/Medivance Arctic Sun 5000

Control group

No Intervention group

Description:

Best medical treatment following international stroke guidelines