On-scene initiation of ECPR for out-of-hospital cardiac arrest

ON-SCENE Initiation of Extracorporeal CardioPulmonary Resuscitation (ECPR) During Refractory Out-of-Hospital Cardiac Arrest

This study tests if starting a special type of heart support right at the scene of a cardiac arrest can help young adults survive and recover better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 390 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Erasmus Medical Center (Academic / other)
• Locations: 4 sites (Amsterdam and 3 other locations)
• Trial ID: NCT04620070 on ClinicalTrials.gov

What this trial studies

This study investigates the implementation of extracorporeal cardiopulmonary resuscitation (ECPR) by Helicopter Emergency Medical Services (HEMS) teams for patients experiencing refractory out-of-hospital cardiac arrest. The approach aims to provide immediate advanced life support on-site, potentially improving the chances of return of spontaneous circulation (ROSC) and enhancing survival rates with better neurological outcomes. The study focuses on patients aged 18 to 50 who have witnessed cardiac arrests and meet specific criteria. By addressing the challenges of transporting patients to hospitals, this intervention seeks to optimize care and reduce healthcare costs.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 50 who have experienced a witnessed cardiac arrest with signs of life and meet specific medical criteria.

Not a fit: Patients with known malignancies or recent intracranial hemorrhages are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and neurological outcomes for patients experiencing cardiac arrest outside of a hospital setting.

How similar studies have performed: Previous studies have shown promising results with ECPR in hospital settings, but this approach of on-scene initiation is relatively novel and untested.

Eligibility criteria

Inclusion Criteria:

* - Age between 18 and 50 years, known or as estimated at inclusion by the HEMS physician.
* Witnessed arrest (last seen well \<5 min), OR signs of life (gasping, movement)
* Initial rhyme is VT/VF OR Suspected of having a pulmonary embolism
* Refractory cardiac arrest lasting longer than 20 minutes and shorter than 45 min

If age is not exactly known at inclusion and is estimated by the HEMS physician between 18 and 50 years but finally the patient appears to be younger or older, the patient will not be excluded.

Exclusion Criteria:

* - CO2 et\<1.2 kPa (10 mmHg) during CPR
* No clear echographic visualisation of either the femoral artery or the femoral vein.
* Expected time from collapse to arrival at an ECPR center with a direct available ECPR team is less than 30 min.

The following patients will be withdrawn after initial inclusion as soon as the following information becomes available:

* Known malignancy
* Known intracranial haemorrhage/ischemia \<6 weeks
* Care dependent for daily activities before arrest
* Patients with a "do not resuscitate" order, which was not known at time of the arrest.
* Refusal of deferred consent by the next of kin or by the patient himself to use the data. Deferred consent will not be asked to relatives of patients who die in scene, but are included in the study.

Where this trial is running

Amsterdam and 3 other locations

• Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
• Umcg — Groningen, Netherlands (Recruiting)
• Radboud — Nijmegen, Netherlands (Recruiting)
• ErasmusMC — Rotterdam, Netherlands (Recruiting)

Study contacts

• Principal investigator: Dinis Reis Miranda — Erasmus Medical Center
• Study coordinator: Dinis Reis Miranda, MD.PhD

Conditions Extracorporeal Membrane Oxygenation; Cardiac Arrest; ECPR; prehospital ECPR; out of hospital cardiac arrest