The OSIRIS ECPR Trial

Launched by GENERAL UNIVERSITY HOSPITAL, PRAGUE · Jan 30, 2025

Keywords

ClinConnect Summary

The OSIRIS ECPR Trial is a research study looking at two different methods of helping people who experience a cardiac arrest outside of a hospital. One approach is called extracorporeal cardiopulmonary resuscitation (ECPR), which uses a special machine to support the heart and lungs, while the other is the traditional method of cardiopulmonary resuscitation (CPR). The study aims to see which method works better for patients who have a specific type of cardiac arrest known as ventricular fibrillation or pulseless ventricular tachycardia.

To be part of this trial, participants need to be between 18 and 70 years old, have had a witnessed cardiac arrest, and received CPR from bystanders. They should also have a documented shockable heart rhythm and must meet certain health conditions. If someone joins the trial, they will receive either ECPR or standard CPR based on a random selection process. It’s important to note that this trial is not yet recruiting participants, but it represents a significant effort to improve outcomes for patients who suffer sudden cardiac arrest.

Gender

ALL

Eligibility criteria

• 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