Randomized Embedded Multifactorial Adaptive Platform in ExtraCorporeal Membrane Oxygenation (REMAP ECMO) - Left Ventricular Unloading Study

What this Trial Is About

The trial investigates the use of left ventricular (LV) unloading via intra-aortic balloon pumping (IABP) to improve weaning success from venoarterial extracorporeal membrane oxygenation (VA ECMO) in patients with cardiogenic shock. The study is part of the REMAP ECMO platform, which embeds multiple response adaptive randomized trials within a patient registry. This research aims to fill knowledge gaps about managing ECMO and related therapies, as current practices rely mostly on observational data and expert opinion. Patients are randomized to receive either VA ECMO support with LV unloading through IABP or VA ECMO alone without an unloading device. The IABP must be placed within 8 hours of ECMO initiation for those in the unloading arm. The study also includes a nested physiological substudy assessing the effects of IABP on respiratory and hemodynamic parameters, including microcirculation, macrocirculation, and the impact of positive end-expiratory pressure (PEEP) as an unloading method during decremental PEEP trials. Participants undergo a range of assessments including evaluation of ECMO weaning success at 30 days, mortality rates at 30 days, 90 days, and 1 year, and various clinical parameters during ECMO support such as bleeding events, mechanical ventilation duration, heart function, and quality of life at one year. The physiological substudy collects detailed measurements like heart rate, pulmonary artery catheter data, echocardiography, microcirculation, respiratory parameters, and biomarkers at 24 and 48 hours after ECMO initiation. The study involves long-term follow-up up to one year and tracks health care costs and hospital readmissions.

A Study on the Effects of Left Ventricular Unloading in the Setting of VA ECMO Support