A randomized embedded multifactorial adaptive platform for extra corporeal membrane oxygenation (REMAP ECMO) - design and rationale of the left ventricular unloading trial domain.
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van Steenwijk Myrthe P J, van Rosmalen Joost, Elzo Kraemer Carlos V, Donker Dirk W, Hermens Jeannine A J M, Kraaijeveld Adriaan O, Maas Jacinta J, Akin Sakir, Montenij Leon J, Vlaar Alexander P J, van den Bergh Walter M, Oude Lansink-Hartgring Annemieke, de Metz Jesse, Voesten Niek, Boersma Eric, Scholten Erik, Beishuizen Albertus, Lexis Chris P H, Peperstraete Harlinde, Schiettekatte Simon, Lorusso Roberto, Gommers Diederik A M P J, Tibboel Dick, de Boer Rudolf A, Van Mieghem Nicolas M D A, Meuwese Christiaan L, REMAP ECMO LV unloading study group
Аннотация
METHODS: REMAP ECMO describes a registry-based platform allowing for the embedding of multiple response adaptive RCTs (trial domains) which can perpetually address the effect of relevant patient management issues on ECMO weaning success. A first trial domain studies the effects of LV unloading by means of an IABP as an adjunct to veno-arterial (V-A) ECMO versus V-A ECMO alone on ECMO weaning success at 30 days in adult cardiogenic shock patients admitted to the Intensive Care Unit (ICU). The primary outcome of this trial is "successful weaning from ECMO" being defined as a composite of survival without the need for mechanical circulatory support, heart transplantation, or left ventricular assist device (LVAD) at 30 days after initiation of ECMO. Secondary outcomes include the need for interventional escalation of LV unloading strategy, mechanistic endpoints, survival characteristics until 1 year after ECMO initiation, and quality of life. Trial data will be analysed using a Bayesian statistical framework. The adaptive design allows for a high degree of flexibility, such as response adaptive randomization and early stopping of the trial for efficacy or futility. The REMAP ECMO LV unloading study is approved by the Medical Ethical Committee of the Erasmus Medical Center and is publicly registered.
CONCLUSION: This REMAP ECMO trial platform enables the efficient roll-out of multiple RCTs on relevant patient management issues. A first embedded trial domain will compare routine LV unloading by means of an IABP as an adjunct to V-A ECMO versus V-A ECMO alone.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT05913622.