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Not yet recruiting NCT06805344

The OSIRIS ECPR Trial

No phase Interventional Cardiac Arrest Ventricular Fibrillation Out-Of-Hospital Cardiac Arrest Sudden Cardiac Arrest

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Extracorporeal cardiopulmonary resuscitation based approach, Conventional cardiopulmonary resuscitation.
Who it may be relevant to
Registry conditions: Cardiac Arrest, Ventricular Fibrillation, Out-Of-Hospital Cardiac Arrest, Sudden Cardiac Arrest. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 90-day survival [Time frame: 90-days]
Secondary outcome measures (2)
  • 90-day neurological outcome [Time frame: 90-days]
  • 90-day Health-related quality of life [Time frame: 90-days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06805344 · 442024-41/24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗