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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
| Heinrich-Heine University, Duesseldorf | OTHER |
| University Hospital Freiburg | OTHER |
| University Medical Centre Ljubljana |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 90-day survival | 90-day survival | 90-days |
| Measure | Description | Time Frame |
|---|---|---|
| 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-days |
| 90-day Health-related quality of life |
| Measure | Description | Time Frame |
|---|---|---|
| Survival to discharge | Survival to hospital discharge for the index event | up to 90-days |
| 30-day survival | 30-day survival | 30-days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Bělohlávek, MD, PhD | Contact | +420724371594 | jan.belohlavek@vfn.cz | |
| Daniel Rob, MD, PhD | Contact | +420721932067 | daniel.rob@vfn.cz |
| Name | Affiliation | Role |
|---|---|---|
| Jan Bělohlávek, MD, PhD | General University Hospital, Prague | Principal Investigator |
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| OTHER |
| Medical University of Vienna | OTHER |
| Hospital Vall d'Hebron | OTHER |
| Heart Center Leipzig - University Hospital | OTHER |
| Aarhus University Hospital | OTHER |
| Royal Brompton & Harefield NHS Foundation Trust | OTHER |
| Region Hovedstadens Apotek | OTHER_GOV |
| Ludwig-Maximilians - University of Munich | OTHER |
| European Clinical Research Infrastructure Network | OTHER |
| Masaryk University | OTHER |
| Insel Gruppe AG, University Hospital Bern | OTHER |
| University Hospital, Zürich | OTHER |
| University of London | OTHER |
| Uniwersytet Wrocławski | UNKNOWN |
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.
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|
| 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. |
|
|
90-day Health-related quality of life (HRQoL) using EuroQol 5-Dimension 5-Level (EQ5D-5L)
| 90-days |
| 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) | up to 90-days |
| 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) | 30-days |
| Neurological outcome at 30 days or discharge | 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) | discharge date or 30-days |
| Win ratio | Win ratio (Dead vs alive, all steps on the mRS-scale, safety event, HRQoL) | up to 90-days |
| Potential organ donor | Number of participants fulfilling criteria of donor after brain death (DBD) or donor after circulatory death (DCD)) | up to 90-days |
| Accepted organ donor | 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. | up to 90-days |
| Additional mechanical circulatory support (MCS) implantation | Additional mechanical circulatory support (MCS) implantation (any MCS use in the standard arm or additional MCS implantation to ECMO in the intervention arm) | up to 90-days |
| Best neurological outcome at any time within 90 days (mRS scale) | 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). | up to 90-days |
| Cardiovascular mortality at 90 days | Mortality due to myocardial infarction, heart failure, cardiogenic shock, cardiac arrhytmia, rearrest, ischemic stroke | 90-days |
| Major Adverse Cardiovascular Events (MACE) at 90 days | MACE include CV death, nonfatal MI, stroke, resuscitated cardiac arrest | 90-days |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D014693 | Ventricular Fibrillation |
| D058687 | Out-of-Hospital Cardiac Arrest |
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003645 | Death, Sudden |
| D003643 | Death |
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