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.
Age ≥18 and ≤ 70 years presumed or known
Witnessed OHCA
Bystander CPR provided
Presumed cardiac or unknown cause
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
Parallel
Extracorporeal cardiopulmonary resuscitation based approach
Procedure/SurgeryECPR-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.
Conventional cardiopulmonary resuscitation
Procedure/SurgeryCCPR is defined as conventional ACLS per current guidelines without MCS use until sustained ROSC is achieved or the patient pronounced dead.
90-day survival
90-day survival
90-day neurological outcome
90-day neurological outcome measured using the modified Rankin Scale (mRS-scale) (mRS 0-3 indicating a good outcome, and mRS 4-6 indicating a poor outcome)
90-day Health-related quality of life
90-day Health-related quality of life (HRQoL) using EuroQol 5-Dimension 5-Level (EQ5D-5L)
Survival to discharge
Survival to hospital discharge for the index event
30-day survival
30-day survival
Neurological outcome at discharge
Neurological outcome at discharge from index hospitalization (mRS 0-3 indicating a good outcome, and mRS 4-6 indicating a poor outcome)
Neurological outcome at 30 days
Neurological outcome at 30 days (mRS 0-3 indicating a good outcome, and mRS 4-6 indicating a poor outcome)
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General University Hospital, Prague
Lead sponsor
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
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