NCT01847482已完成不适用
COOL-ARREST JP: A Multicenter, Prospective, Single-arm Interventional Trial to Evaluate Therapeutic Hypothermia With IntraVascular Temperature Management (IVTM) in Post-Cardiogenic Cardiac Arrest and Post-Return of Spontaneous Circulation Patients
ZOLL Circulation, Inc., USA20 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2013年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 20
- 主要终点
- Core temperature achievement ratio
研究概览
简要总结
A multicenter, single-arm, prospective, interventional trial to evaluate therapeutic hypothermia with intravascular temperature management (IVTM) in post-cardiogenic cardiac arrest, post-return of spontaneous circulation (ROSC) patients in Japan.
The objective of this study is to verify that therapeutic hypothermia performed by intravascular cooling using the investigational device (IVTM) can control body temperature appropriately in post-cardiogenic cardiac arrest, post-ROSC patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-traumatic in-hospital or out-of-hospital cardiac arrest
- •Unwitnessed cardiac arrest (Ventricular fibrillation), or witnessed cardiac arrest (ventricular fibrillation, pulseless electrical activity, asystole within 15 minutes following onset)
- •Patient is at least 20 years of age and less than 80 years of age with consent is given
- •In the judgement of an investigator or sub-investigator, the patient is unable to follow verbal instructions
- •Therapeutic hypothermia using the investigational device can be initiated within six hours of Return of Spontaneous Circulation (ROSC)
- •Written consent can be obtained from a legally acceptable representative
排除标准
- •Traumatic cardiac arrest (blunt trauma, penetrating trauma, burns, exsanguination, suffocation, smoke inhalation, near drowning, etc)
- •Accidental hypothermia with core body temperature less than 35.0°C
- •Pregnant or of child bearing potential
- •Patient has given or indicated a Do Not Resuscitate (DNR) order
- •Femoral venous access is contraindicated by previous surgey, medical history, anatomy or the like
- •An inferior vena cava filter is in place
- •Patient has severe bleeding (Pulmonary hemorrhage, gastrointestinal hemorrhage, etc.)
- •Intracranial hemorrhage as confirmed by CT scanning
- •Hemodynamic instability despite use of vasopressor agents and cardiac stimulants
- •Heparin hypersensitivity
- •Serious systemic infectious diseases (sepsis, etc.)
- •Platelet count less than 30,000/mm3
- •Serious hepatic dysfunction
- •Serious renal impairment
- •Using percutaneous cardiopulmonary support (PCPS)
- •Using continuous hemodiafiltration (CHDF)
- •Therapeutic hypothermia has been otherwise implemented between ROSC and the start of the study (excluding the rapid infusion of non-glucose-containing cold electrolyte fluid, or non-glucose-containing cold plasma volume expander)
- •The patient's core body temperature cannot be monitored
- •Currently participating in another clinical trial or has participated in another clinical trial within the past six months
- •in the judgement of an investigator or sub-investigator, participation in this clinical trial is inappropriate for the patient
研究组 & 干预措施
Therapeutic Hypothermia
Experimental
干预措施: ZOLL Intravascular Temperature Management System (IVTM) (Device)
结局指标
主要结局
Core temperature achievement ratio
时间窗: Baseline and 3 hours
次要结局
- Cerebral Performance Category (CPC)(Baseline and 14 days)
- Cooling speed(Baseline and 3 hours)
- Change in body temperature(Baseline and 96 hours)
- Modified Rankin Scale (mRS)(Baseline and 14 days)
- Safety(Baseline vs. 14 days)
研究者
研究点 (20)
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