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
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Body core temperature
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •(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)
- •Known intolerance or allergy against acetaminophen, buspirone, clonidine, magnesium sulphate or pethidine.
- •Treatment with MAO-inhibitors ≤ 14 days
- •Acute closed-angle glaucoma
结局指标
主要结局
Body core temperature
时间窗: 0 to 48h
Primary endpoint: Time to primary target body core temperature (34°C) after hypothermia-induction.
次要结局
- Efficacy(0 to 48h)
- Tolerability(0 to 48h)
- Practicability(0 to 48h)
- Safety(0 to d90)
研究者
Dr. Sven Poli, MD MSc FESO
Dr. Sven Poli, Consultant Neurologist, Principal Investigator
University Hospital Heidelberg