Cardiac ArrestOSIRISNCT06805344
The OSIRIS ECPR Trial
A study testing Extracorporeal cardiopulmonary resuscitation based approach and Conventional cardiopulmonary resuscitation in people with Cardiac Arrest and Ventricular Fibrillation, run by General University Hospital, Prague.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cardiac Arrest, Ventricular Fibrillation, Out-Of-Hospital Cardiac Arrest
- What is being tested?
- Extracorporeal cardiopulmonary resuscitation based approach and Conventional cardiopulmonary resuscitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 686 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Out-of-hospital Refractory Cardiac Arrest Treated with Extracorporeal Cardiopulmonary Resuscitation
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.
Read the 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:
- increases survival in selected adults with refractory OHCA.
- 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.
- Conditions
- Cardiac Arrest, Ventricular Fibrillation, Out-Of-Hospital Cardiac Arrest, Sudden Cardiac Arrest, Extracorporeal Cardiopulmonary Resuscitation, Extracorporeal Membrane Oxygenation
- Being tested
- Extracorporeal cardiopulmonary resuscitation based approach, Conventional cardiopulmonary resuscitation
- Keywords
- cardiac arrest, extracorporeal cardiopulmonary resuscitation, extracorporeal membrane oxygenation, out-of-hospital cardiac arrest
- Medical subject headings
- Heart Arrest, Ventricular Fibrillation, Out-of-Hospital Cardiac Arrest, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal cardiopulmonary resuscitation based approachProcedure or surgery
Also called ECPR-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.
Conventional cardiopulmonary resuscitationProcedure or surgery
Also called CCPR
CCPR is defined as conventional ACLS per current guidelines without MCS use until sustained ROSC is achieved or the patient pronounced dead.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Conventional cardiopulmonary resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day survival
90-day survival
Measured: 90-days
Secondary outcomes (2)
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)
Measured: 90-days
90-day Health-related quality of life
90-day Health-related quality of life (HRQoL) using EuroQol 5-Dimension 5-Level (EQ5D-5L)
Measured: 90-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 686 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General University Hospital, Prague
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Jan Bělohlávek, General University Hospital, Prague
- Investigators
- Jan Bělohlávek, MD, PhD, Principal investigator, General University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805344
- Sponsor's protocol ID
- 442024-41/24
- Acronym
- OSIRIS
- Status last verified
- Jan 2025
- First submitted
- 8 Apr 2024
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Out-of-hospital Refractory Cardiac Arrest Treated with Extracorporeal Cardiopulmonary Resuscitation
- ClinicalTrials.gov ID
- NCT06805344
- Acronym / sponsor ID
- OSIRIS / 442024-41/24
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 686 participants (estimated)
- Lead sponsor
- General University Hospital, PragueUniversity, hospital or other
- Collaborators
- 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
- Study start
- Feb 2025 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- increases survival in selected adults with refractory OHCA.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ECPR-based | Experimental | Procedure: Extracorporeal cardiopulmonary resuscitation based approachECPR-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 | Procedure: Conventional cardiopulmonary resuscitationCCPR 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal cardiopulmonary resuscitation based approachAlso: ECPR-based approachECPR-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 or surgery | ECPR-based |
| Conventional cardiopulmonary resuscitationAlso: CCPRCCPR is defined as conventional ACLS per current guidelines without MCS use until sustained ROSC is achieved or the patient pronounced dead. | Procedure or surgery | CCPR |
Primary outcome
90-day survival
Time frame: 90-days
90-day survival
2 secondary outcomes
90-day neurological outcome
Time frame: 90-days
90-day Health-related quality of life
Time frame: 90-days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jan Bělohlávek, MD, PhD principal investigator
General University Hospital, Prague
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal cardiopulmonary resuscitation based approach and Conventional cardiopulmonary resuscitation in people with Cardiac Arrest and Ventricular Fibrillation, run by General University Hospital, Prague.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Bělohlávek, MD, PhD (+420724371594, jan.belohlavek@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day survival (time frame: 90-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025; AzTrials last refreshed its copy on 26 Oct 2026.