Emergency Total ExtraCorporeal Life Support Versus Standard Advanced Cardiac Life Support With Extracorporeal Membrane Oxygenation Bailout for Survival With Favorable Neurological Outcome in Refractory Out-of-Hospital Cardiac Arrest – ECLS- OHCA trial

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Abstract

Background Out-of-hospital cardiac arrest (OHCA) is a highly time-sensitive medical emergency. Extracorporeal membrane oxygenation (ECMO)-facilitated resuscitation, also known as extracorporeal cardiopulmonary resuscitation (ECPR), has been increasingly used in patients with refractory cardiac arrest. Despite promising results from observational studies, recent randomized controlled trials have reported conflicting evidence on the benefits of ECPR for refractory OHCA. This trial is designed to investigate the efficacy of expedited ECPR for refractory shockable OHCA using a strict ECPR application protocol and active left ventricular (LV) unloading strategies. Methods This is a multicenter randomized clinical trial (ClinicalTrials.gov NCT06692075). Eligible patients will be randomized in 1:1 ratio on arrival at emergency department into the emergency total extracorporeal life support ( total ECLS ) group and the standard advanced cardiac life support with the ECMO bailout ( standard ACLS ) group. For the emergency total ECLS group, patients will receive early initiation of ECMO within 15 minutes after randomization or up to 60 minutes after emergency calls. For standard ACLS with the ECMO bailout group, patients will receive standard ACLS for at least 15 minutes before initiating bailout ECMO. Survived patients without contraindications for coronary angiography will be transferred to the catheterization laboratory. Institutional protocols of post-cardiac arrest care will adhere to established recommendations from the latest guidelines. Active LV unloading is suggested if indicated. The primary endpoint is survival with a favorable neurological outcome at 30 days. Conclusion The ECLS-OHCA trial aims to provide complementary evidence supporting the use of ECPR in patients with refractory shockable OHCA and to assess the cost-effectiveness of its early implementation. ClinicalTrials.gov: NCT06692075.

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