The OSIRIS ECPR Trial (NCT06805344) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The OSIRIS ECPR Trial
686 participantsStarted 2025-02
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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
✓. Body morphology able to accommodate a mechanical chest compression device
✓. ECPR team and intensive care unit (ICU) capacity in the receiving center available
Exclusion criteria
✕. 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)