NCT01833312终止3 期
EuroHYP-1: European Multicentre, Randomised, Phase III Clinical Trial of Therapeutic Hypothermia Plus Best Medical Treatment Versus Best Medical Treatment Alone for Acute Ischaemic Stroke
University of Erlangen-Nürnberg Medical School1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2013年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- modified Rankin scale
研究概览
简要总结
The purpose of this study is to determine if systemic cooling to a target temperature of 34 to 35°C, started within 6 hours of symptom onset and maintained for 12 hours, improves functional outcome at 3 months in patients with acute ischaemic stroke.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained from the patient or his/her legally acceptable representative or under such other arrangements as may be legally established in participating countries
- •Patients of both sexes aged ≥18 years
- •Estimated body weight of 50 up to and including 120kg
- •Diagnosis of acute ischaemic stroke
- •Possibility to start therapeutic hypothermia within 6 hours after onset of stroke
- •Possibility to start therapeutic hypothermia within 150 minutes after start of alteplase administration in patients receiving thrombolysis at the trial site or within 150 minutes after start of endovascular treatment, if this is later
- •Possibility to start therapeutic hypothermia within 150 minutes after admission to trial site in patients not receiving thrombolysis or in patients who have received thrombolysis at a different site
- •mRS score ≤2 prior to onset of stroke
- •NIHSS score ≥6
- •GCS motor response subscale score ≥5
排除标准
- •Use of monoamineoxidase inhibitors in the 14 days prior to screening
- •Current use of medication interacting with pethidine or buspirone, i.e., ritonavir, phenytoin, cimetidine, phenothiazines, opioids and partial opioid agonists (e.g., pentazocine, nalbuphine, buprenorphine)
- •Acute alcohol intoxication
- •Opioid addiction
- •Nursing mother or pregnant woman, as verified by a positive urine pregnancy test in females of childbearing potential
- •Known hypersensitivity to the IMPs or any of their formulation ingredients
- •Patient who is imprisoned or is lawfully kept in an institution
- •Employee or direct relative of an employee of the CRO (if applicable), the department of the investigator, or the sponsor
- •Participation in an interventional clinical trial within the last 4 weeks, or be under the exclusion period from another trial
- •Prior participation in this trial
- •Any acutely life-threatening conditions other than acute ischaemic stroke
- •Rapidly resolving stroke symptoms
- •Evidence from CT or MRI of intracranial haemorrhage or tumour or encephalitis or any diagnosis likely to cause the present symptoms other than acute ischaemic stroke. Haemorrhagic transformation of the infarct is not an exclusion criterion, except when there is a parenchymal haematoma covering more than 30% of the infarcted area, with significant space-occupying effect, or when there is a bleeding remote from the infarcted area
- •Known convulsive disorder, acute closed angle glaucoma, myasthenia gravis
- •SPO2 <94% (as measured by pulse oximetry) under nasal oxygen administration
- •Other severe respiratory disorder
- •Bradycardia (<40 bpm)
- •Severe cardiac failure, defined as NYHA classification ≥III
- •Myocardial infarction or angina pectoris in the 3 months prior to screening
- •Vasospastic disorders (e.g., Raynaud's disease)
- •Haematological dyscrasia (e.g., sickle cell disease, cryoglobulinaemia)
- •Known platelet count <100,000/mm3
- •Known INR >1.7
- •Skin damage (e.g., inflammation, burns, injuries, ulcerations, hives, rash) at the sites intended to be used for cooling
- •Clinical diagnosis of sepsis
- •Known severe hepatic impairment (serum ALAT and/or ASAT >3 times ULN)
- •Known renal impairment (serum creatinine >2mg/100ml)
- •Addison's disease
- •Any other condition that may interfere with, or be aggravated by, therapeutic hypothermia
- •Any condition that is thought to reduce the compliance to cooperate with the trial procedures
研究组 & 干预措施
Hypothermia
Experimental
Best medical treatment + hypothermia 34-35°C for 24h
干预措施: Hypothermia (Device)
Hypothermia
Experimental
Best medical treatment + hypothermia 34-35°C for 24h
干预措施: Buspirone (Drug)
Hypothermia
Experimental
Best medical treatment + hypothermia 34-35°C for 24h
干预措施: Pethidine (Drug)
结局指标
主要结局
modified Rankin scale
时间窗: 3 months
Analysed with ordinal logistic regression and expressed as a common odds ratio.
次要结局
- Cerebral infarct size(48±24 hours)
- Mortality(3 months)
- Neurological outcome(3 months)
- Quality of life(3 months)
- Safety of systemic cooling(Enrollment - day 91)
- Tolerability of systemic cooling(36 hours)
研究者
研究点 (1)
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