Advanced REperfusion STrategies for Refractory Cardiac Arrest (The ARREST Trial)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Survival
研究概览
简要总结
This is a Phase II, single center (Under the Center for Resuscitation Medicine at the University of Minnesota Medical School), partially blinded, prospective, intention to treat, safety and efficacy clinical trial, randomizing adult patients (18-75 years old) with refractory ventricular fibrillation/pulseless ventricular tachycardia (VF/VT) out-of hospital cardiac arrest (OHCA) who are transferred by emergency medical services (EMS) with ongoing mechanical cardiopulmonary resuscitation (CPR) or who are resuscitated to receive one of the 2 local standards of care practiced in our community: 1) Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation or 2) Standard Advanced Cardiac Life Support (ACLS) Resuscitation
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (presumed or known to be aged 18-75 years, inclusive),
- •An initial documented OHCA rhythm of VF/VT,
- •No ROSC following 3 defibrillation shocks,
- •Body morphology able to accommodate a Lund University Cardiac Arrest System (LUCAS™) automated CPR device, and
- •Estimated transfer time from the scene to the ED or CCL of < 30 minutes.
排除标准
- •Age < 18 years old or > 75 years old;
- •Non-shockable initial OHCA rhythm (pulseless electrical activity [PEA] or asystole);
- •Valid do-not-attempt-resuscitation orders (DNAR);
- •Blunt, penetrating, or burn-related injury, drowning, electrocution or known overdose;
- •Known prisoners;
- •Known pregnancy;
- •Nursing home residents;
- •Unavailability of the cardiac catheterization laboratory.
- •Severe concomitant illness that drastically shortens life expectancy or increases risk of the procedure;
- •Absolute contraindications to emergent coronary angiography including known anaphylactic reaction to angiographic contrast media and/or active gastrointestinal or internal bleeding
结局指标
主要结局
Survival
时间窗: Approximately 25 days
Number of participants who survived to hospital discharge
次要结局
- Cerebral Performance Categories (CPC) Scale(At hospital discharge (average of 25 days), 3 months, 6 months)
- Treatment Cost(6 months)
- Modified Rankin Scale (mRS) Score(At hospital discharge (average of 25 days), 3 months, 6 months)