Cardiac Arrest, Extracorporeal Cardiopulmonary Resuscitation, Extracorporeal Membrane Oxygenation, Out-Of-Hospital Cardiac Arrest, Sudden Cardiac Arrest, Ventricular Fibrillation
Conditions
Keywords
cardiac arrest, extracorporeal cardiopulmonary resuscitation, extracorporeal membrane oxygenation, out-of-hospital cardiac arrest
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.
Interventions
PROCEDUREExtracorporeal 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.
PROCEDUREConventional 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
Karolinska Institutet
Heinrich-Heine University, Duesseldorf
University Hospital Freiburg
University Medical Centre Ljubljana
Medical University of Vienna
Hospital Vall d'Hebron
Heart Center Leipzig - University Hospital
Aarhus University Hospital
Royal Brompton & Harefield NHS Foundation Trust
Region Hovedstadens Apotek
Ludwig-Maximilians - University of Munich
European Clinical Research Infrastructure Network
Masaryk University
Insel Gruppe AG, University Hospital Bern
University Hospital, Zürich
University of London
Uniwersytet Wrocławski
General University Hospital, Prague
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 90-day survival | 90-days | 90-day survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 90-day neurological outcome | 90-days | 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-days | 90-day Health-related quality of life (HRQoL) using EuroQol 5-Dimension 5-Level (EQ5D-5L) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Neurological outcome at 30 days | 30-days | Neurological outcome at 30 days (mRS 0-3 indicating a good outcome, and mRS 4-6 indicating a poor outcome) |
| Neurological outcome at 30 days or discharge | discharge date or 30-days | Neurological outcome at 30 days or discharge whatever comes first measured using the mRS scale (mRS 0-3 good outcome, mRS 4-6 poor outcome) |
| Win ratio | up to 90-days | Win ratio (Dead vs alive, all steps on the mRS-scale, safety event, HRQoL) |
| Potential organ donor | up to 90-days | Number of participants fulfilling criteria of donor after brain death (DBD) or donor after circulatory death (DCD)) |
| Survival to discharge | up to 90-days | Survival to hospital discharge for the index event |
| Additional mechanical circulatory support (MCS) implantation | up to 90-days | Additional mechanical circulatory support (MCS) implantation (any MCS use in the standard arm or additional MCS implantation to ECMO in the intervention arm) |
| Best neurological outcome at any time within 90 days (mRS scale) | up to 90-days | Best neurological outcome at any time within 90 days, assessed using the mRS scale (mRS 0-3 indicating a favorable outcome and mRS 4-6 indicating an unfavorable outcome). |
| Cardiovascular mortality at 90 days | 90-days | Mortality due to myocardial infarction, heart failure, cardiogenic shock, cardiac arrhytmia, rearrest, ischemic stroke |
| Major Adverse Cardiovascular Events (MACE) at 90 days | 90-days | MACE include CV death, nonfatal MI, stroke, resuscitated cardiac arrest |
| Accepted organ donor | up to 90-days | Number of participants with DBD or DCD who met the established medical, legal, and ethical criteria for organ donation and whose organs were harvested for transplantation. |
| 30-day survival | 30-days | 30-day survival |
| Neurological outcome at discharge | up to 90-days | Neurological outcome at discharge from index hospitalization (mRS 0-3 indicating a good outcome, and mRS 4-6 indicating a poor outcome) |
Contacts
Primary ContactJan Bělohlávek, MD, PhD
Backup ContactDaniel Rob, MD, PhD
Outcome results
None listed