The OSIRIS ECPR Trial

NCT06805344 | Not Yet Recruiting DMC

• 1 other identifier: 442024-41/24
• Study Type: interventional
• Target: 686
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• 90-day survival

  90-day survival

  90-days

Secondary Outcomes (2)

• 90-day neurological outcome

  90-days

• 90-day Health-related quality of life

  90-days

Other Outcomes (12)

• Survival to discharge

  up to 90-days

• 30-day survival

  30-days

• Neurological outcome at discharge

  up to 90-days

Study Arms (2)

ECPR-based

EXPERIMENTAL

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.

Procedure: Extracorporeal cardiopulmonary resuscitation based approach

CCPR

ACTIVE COMPARATOR

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.

Procedure: Conventional cardiopulmonary resuscitation

Interventions

Extracorporeal cardiopulmonary resuscitation based approach PROCEDURE

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.

Also known as: ECPR-based approach

ECPR-based

Conventional cardiopulmonary resuscitation PROCEDURE

CCPR is defined as conventional ACLS per current guidelines without MCS use until sustained ROSC is achieved or the patient pronounced dead.

Also known as: CCPR

CCPR

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• General University Hospital, Prague: lead
• Karolinska Institutet: collaborator
• Heinrich-Heine University, Duesseldorf: collaborator
• University Hospital Freiburg: collaborator
• University Medical Centre Ljubljana: collaborator
• Medical University of Vienna: collaborator
• Hospital Vall d'Hebron: collaborator
• Heart Center Leipzig - University Hospital: collaborator
• Aarhus University Hospital: collaborator
• Royal Brompton & Harefield NHS Foundation Trust: collaborator
• Region Hovedstadens Apotek: collaborator
• Ludwig-Maximilians - University of Munich: collaborator
• European Clinical Research Infrastructure Network: collaborator
• Masaryk University: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• University Hospital, Zürich: collaborator
• University of London: collaborator
• Uniwersytet Wrocławski: collaborator

MeSH Terms

Conditions

Heart Arrest; Ventricular Fibrillation; Out-of-Hospital Cardiac Arrest; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Death, Sudden; Death

Study Officials

• Jan Bělohlávek, MD, PhD

  General University Hospital, Prague

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Bělohlávek, MD, PhD

CONTACT

+420724371594; jan.belohlavek@vfn.cz

Daniel Rob, MD, PhD

CONTACT

+420721932067; daniel.rob@vfn.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: February 3, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share