Out-of-hospital Refractory Cardiac Arrest Treated with Extracorporeal Cardiopulmonary Resuscitation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 686
- Primary Endpoint
- 90-day survival
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: 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.
Intervention: Conventional cardiopulmonary resuscitation (Procedure)
Outcomes
Primary Outcomes
90-day survival
Time Frame: 90-days
90-day survival
Secondary Outcomes
- 90-day neurological outcome(90-days)
- 90-day Health-related quality of life(90-days)
Investigators
Jan Bělohlávek
professor
General University Hospital, Prague