NCT06805344

The OSIRIS ECPR Trial

Out-of-hospital Refractory Cardiac Arrest Treated with Extracorporeal Cardiopulmonary Resuscitation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 686 (estimated)
• Sponsor: General University Hospital, Prague · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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: 1. increases survival in selected adults with refractory OHCA. 2. and can be successfully implemented in different cities and countries. The study will include adults 18-70 years of age suffering refractory OHCA of presumed cardiac cause. Refractory OHCA is characterized as either 3 unsuccessful defibrillations in ongoing shockable rhythms or 10 minutes of ACLS without ROSC in the case of a non-shockable rhythm following the first or second defibrillation.

Conditions

• Cardiac Arrest
• Ventricular Fibrillation
• Out-Of-Hospital Cardiac Arrest
• Sudden Cardiac Arrest
• Extracorporeal Cardiopulmonary Resuscitation
• Extracorporeal Membrane Oxygenation

Interventions

Type	Name	Description
PROCEDURE	Extracorporeal cardiopulmonary resuscitation based approach	ECPR-based approach is defined as ACLS per current guidelines with aim to proceed to in-hospital or out-of-hospital V-A ECMO if ROSC is not achieved before the cannulation.
PROCEDURE	Conventional cardiopulmonary resuscitation	CCPR is defined as conventional ACLS per current guidelines without MCS use until sustained ROSC is achieved or the patient pronounced dead.

Timeline

• Start date: 2025-02-01
• Primary completion: 2029-06-01
• Completion: 2030-06-01
• First posted: 2025-02-03
• Last updated: 2025-02-03