EUCTR2012-002944-25-FI进行中（未招募）1 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 - EuroHYP-1
niversity Hospital Erlangen0 个研究点目标入组 1,500 人开始时间: 2015年4月16日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The trial population consists of patients of both sexes, aged =18 years, with acute ischaemic stroke and a score on the NIHSS of 6 up to and including 18 at screening [Assessment 1, within 90 minutes before the start of the treatment phase TP].
- •?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.
- •?Estimated body weight of 50kg up to and including 120kg.
- •?Possibility to start therapeutic hypothermia within 6 hours after onset of stroke.
- •?Possibility to start therapeutic hypothermia within 90 minutes after start of alteplase administration in patients receiving thrombolysis at the trial site.
- •?Possibility to start therapeutic hypothermia within 90 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.
- •?GCS motor response subscale score =5.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •1.Use of monoaminoxidase inhibitors in the 14 days prior to screening.
- •2.Current use of medication interacting with pethidine or buspirone.
- •3.Acute alcohol intoxication.
- •4.Opioid addiction.
- •5.Nursing mother or pregnant woman, as verified by a positive urine pregnancy test in females of childbearing potential.
- •6.Known hypersensitivity to the IMPs or any of their formulation ingredients.
- •7.Patient who is imprisoned or is lawfully kept in an institution.
- •8.Employee or direct relative of an employee of the CRO (if applicable), the department of the investigator, or the sponsor.
- •9.Participation in an interventional clinical trial within the last 4 weeks, or be under the exclusion period from another trial.
- •10.Prior participation in this trial.
- •11.Any acutely life-threatening conditions other than acute ischaemic stroke.
- •12.Rapidly resolving stroke symptoms.
- •13.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.
- •14.Known convulsive disorder, acute closed angle glaucoma, myasthenia gravis.
- •15.SPO2 <94% (as measured by pulse oximetry) under nasal oxygen administration.
- •16.Other severe respiratory disorder.
- •17.Bradycardia (<40 bpm).
- •18.Severe cardiac failure, defined as NYHA classification =III.
- •19.Myocardial infarction or angina pectoris in the 3 months prior to screening.
- •20.Vasospastic disorders.
- •21.Haematological dyscrasia (e.g., sickle cell disease, cryoglobulinaemia).
- •22.Known platelet count <100,000/mm3.
- •23.Known INR >1.7.
- •24.Skin damage at the sites intended to be used for cooling.
- •25.Clinical diagnosis of sepsis.
- •26.Known severe hepatic impairment (serum ALAT and/or ASAT >3 times ULN).
- •27.Known renal impairment (serum creatinine >2mg/100ml).
- •28.Addison’s disease.
- •29.Any other condition that may interfere with, or be aggravated by, therapeutic hypothermia.
- •30.Any condition that is thought to reduce the compliance to cooperate with the trial procedures .
研究者
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