Clinical trial NCT06805344: The OSIRIS ECPR Trial
Official title: Out-of-hospital Refractory Cardiac Arrest Treated with Extracorporeal Cardiopulmonary Resuscitation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiac Arrest
Ventricular Fibrillation
Out-Of-Hospital Cardiac Arrest
Sudden Cardiac Arrest
Extracorporeal Cardiopulmonary Resuscitation
Extracorporeal Membrane Oxygenation
Keywords: cardiac arrest
extracorporeal cardiopulmonary resuscitation
extracorporeal membrane oxygenation
out-of-hospital cardiac arrest
Lead sponsor: General University Hospital, Prague
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Heinrich-Heine University, Duesseldorf
name: University Hospital Freiburg
name: University Medical Centre Ljubljana
name: Medical University of Vienna
name: Hospital Vall d'Hebron
name: Heart Center Leipzig - University Hospital
name: Aarhus University Hospital
name: Royal Brompton & Harefield NHS Foundation Trust
name: Region Hovedstadens Apotek
name: Ludwig-Maximilians - University of Munich
name: European Clinical Research Infrastructure Network
name: Masaryk University
name: Insel Gruppe AG, University Hospital Bern
name: University Hospital, Zürich
name: University of London
name: Uniwersytet Wrocławski
First posted: 2025-02-03
Enrollment: 686
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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:

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 and ≤ 70 years presumed or known
2. Witnessed OHCA
3. Bystander CPR provided
4. Presumed cardiac or unknown cause
5. An initial documented shockable rhythm of VF (ventricular fibrillation) or pulseless VT (ventricular tachycardia)
6. Minimum of ≥ 10 min of ACLS without ROSC or at least ≥ 3 defibrillations in ongoing VF/pulseless VT
7. Body morphology able to accommodate a mechanical chest compression device
8. ECPR team and intensive care unit (ICU) capacity in the receiving center available
9. Estimated transfer time from the scene to the hospital ≤ 30 minutes or to the scene ≤ 30 minutes
10. Eligible for intensive care without restrictions or limitations

Exclusion Criteria:

1. ACLS ≥ 30 minutes before randomization
2. Known limitations in care or a Do Not Attempt to Resuscitate (DNAR) order
3. Known severe disease making 90-day survival unlikely
4. Known bleeding diathesis or acute or recent intracranial bleeding
5. Known, obvious or suspected pregnancy
6. Known pre-arrest severe cognitive dysfunction (mRS ≥ 4)
7. Known hypothermia as a cause of cardiac arrest

Primary outcomes:
measure: 90-day survival
timeFrame: 90-days
Secondary outcomes:
measure: 90-day neurological outcome
timeFrame: 90-days
measure: 90-day Health-related quality of life
timeFrame: 90-days
Other outcomes:
measure: Survival to discharge
timeFrame: up to 90-days
measure: 30-day survival
timeFrame: 30-days
measure: Neurological outcome at discharge
timeFrame: up to 90-days
measure: Neurological outcome at 30 days
timeFrame: 30-days
measure: Neurological outcome at 30 days or discharge
timeFrame: discharge date or 30-days
measure: Win ratio
timeFrame: up to 90-days
measure: Potential organ donor
timeFrame: up to 90-days
measure: Accepted organ donor
timeFrame: up to 90-days
measure: Additional mechanical circulatory support (MCS) implantation
timeFrame: up to 90-days
measure: Best neurological outcome at any time within 90 days (mRS scale)
timeFrame: up to 90-days
measure: Cardiovascular mortality at 90 days
timeFrame: 90-days
measure: Major Adverse Cardiovascular Events (MACE) at 90 days
timeFrame: 90-days
Locations:
Study officials:
affiliation: General University Hospital, Prague
name: Jan Bělohlávek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: