Out-of-hospital Refractory Cardiac Arrest Treated with Extracorporeal Cardiopulmonary Resuscitation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 686
- 主要终点
- 90-day survival
研究概览
简要总结
The OSIRIS trial is an investigator-initiated, multicenter, multinational, open-label, randomized controlled trial with a 2:1 concealed allocation of refractory out-of-hospital cardiac arrest (OHCA) patients to the extracorporeal cardiopulmonary resuscitation (ECPR) based approach versus the conventional cardiopulmonary resuscitation (CCPR) approach.
详细描述
ECPR for OHCA is a resource-intensive method and poses significant challenges for both prehospital and hospital systems. Recent meta-analyses have highlighted persisting uncertainties regarding the routine use of ECPR strategy for OHCA, emphasizing the need for further research.
The refractory OHCA trial is a multicenter, multinational, open-label, randomized trial with a 2:1 concealed allocation of refractory OHCA patients to ECPR-based approach versus CCPR approach.
ECPR-based approach is defined as advanced cardiac life support (ACLS) per current guidelines with aim to proceed to in-hospital or out-of-hospital veno-arterial extracorporeal membrane oxygenation (V-A ECMO) if (return of spontaneous circulation) ROSC is not achieved before the cannulation.
CCPR is defined as conventional ACLS per current guidelines without mechanical circulatory support (MCS) use until sustained ROSC is achieved or the patient pronounced dead.
This study was designed to test the hypothesis that invasive, ECPR-based approach when compared to CCPR:
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and ≤ 70 years presumed or known
- •Witnessed OHCA
- •Bystander CPR provided
- •Presumed cardiac or unknown cause
- •An initial documented shockable rhythm of VF (ventricular fibrillation) or pulseless VT (ventricular tachycardia)
- •Minimum of ≥ 10 min of ACLS without ROSC or at least ≥ 3 defibrillations in ongoing VF/pulseless VT
- •Body morphology able to accommodate a mechanical chest compression device
- •ECPR team and intensive care unit (ICU) capacity in the receiving center available
- •Estimated transfer time from the scene to the hospital ≤ 30 minutes or to the scene ≤ 30 minutes
- •Eligible for intensive care without restrictions or limitations
排除标准
- •ACLS ≥ 30 minutes before randomization
- •Known limitations in care or a Do Not Attempt to Resuscitate (DNAR) order
- •Known severe disease making 90-day survival unlikely
- •Known bleeding diathesis or acute or recent intracranial bleeding
- •Known, obvious or suspected pregnancy
- •Known pre-arrest severe cognitive dysfunction (mRS ≥ 4)
- •Known hypothermia as a cause of cardiac arrest
研究组 & 干预措施
ECPR-based
ECPR-based approach is defined as advanced cardiac life support (ACLS) per current guidelines with aim to proceed to in-hospital or out-of-hospital veno-arterial extracorporeal membrane oxygenation (V-A ECMO) if return of spontaneous circulation (ROSC) is not achieved before the cannulation.
干预措施: Extracorporeal cardiopulmonary resuscitation based approach (Procedure)
CCPR
CCPR is defined as conventional advanced cardiac life support (ACLS) per current guidelines without mechanical circulatory support (MCS) use until sustained return of spontaneous circulation (ROSC) is achieved or the patient pronounced dead.
干预措施: Conventional cardiopulmonary resuscitation (Procedure)
结局指标
主要结局
90-day survival
时间窗: 90-days
90-day survival
次要结局
- 90-day neurological outcome(90-days)
- 90-day Health-related quality of life(90-days)
研究者
Jan Bělohlávek
professor
General University Hospital, Prague