The OSIRIS ECPR Trial

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

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.

Sponsors & Collaborators

• Karolinska Institutet

  collaborator OTHER

• Heinrich-Heine University, Duesseldorf

  collaborator OTHER

• University Hospital Freiburg

  collaborator OTHER

• University Medical Centre Ljubljana

  collaborator OTHER

• Medical University of Vienna

  collaborator OTHER

• Hospital Vall d'Hebron

  collaborator OTHER

• Heart Center Leipzig - University Hospital

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• Royal Brompton & Harefield NHS Foundation Trust

  collaborator OTHER

• Region Hovedstadens Apotek

  collaborator OTHER_GOV

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• European Clinical Research Infrastructure Network

  collaborator OTHER

• Masaryk University

  collaborator OTHER

• Insel Gruppe AG, University Hospital Bern

  collaborator OTHER

• University Hospital, Zürich

  collaborator OTHER

• University of London

  collaborator OTHER

• Uniwersytet Wrocławski

  collaborator UNKNOWN

• General University Hospital, Prague

  lead OTHER

Principal Investigators

• Jan Bělohlávek, MD, PhD · General University Hospital, Prague

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-28

Primary Completion

2029-06-30

Completion

2030-06-30