TY - JOUR
T1 - A randomized embedded multifactorial adaptive platform for extra corporeal membrane oxygenation (REMAP ECMO) – design and rationale of the left ventricular unloading trial domain
AU - van Steenwijk, Myrthe P J
AU - van Rosmalen, Joost
AU - Kraemer, Carlos V Elzo
AU - Donker, Dirk W
AU - Hermens, Jeannine A J M
AU - Kraaijeveld, Adriaan O
AU - Maas, Jacinta J
AU - Akin, Sakir
AU - Montenij, Leon J
AU - Vlaar, Alexander P J
AU - van den Bergh, Walter M
AU - Lansink-Hartgring, Annemieke Oude
AU - de Metz, Jesse
AU - Voesten, Niek
AU - Boersma, Eric
AU - Scholten, Erik
AU - Beishuizen, Albertus
AU - Lexis, Chris P H
AU - Peperstraete, Harlinde
AU - Schiettekatte, Simon
AU - Lorusso, Roberto
AU - Gommers, Diederik A M P J
AU - Tibboel, Dick
AU - de Boer, Rudolf A
AU - Van Mieghem, Nicolas M D A
AU - Meuwese, Christiaan L
N1 - Publisher Copyright:
© 2024 The Author(s)
PY - 2024/10/22
Y1 - 2024/10/22
N2 - Background: The use of Extracorporeal Membrane Oxygenation (ECMO) remains associated with high rates of complications, weaning failure and mortality which can be partly explained by a knowledge gap on how to properly manage patients on ECMO support. To address relevant patient management issues, we designed a “Randomized Embedded Multifactorial Adaptive Platform (REMAP)” in the setting of ECMO (REMAP ECMO) and a first embedded randomized controlled trial (RCT) investigating the effects of routine early left ventricular (LV) unloading through intra-aortic balloon pumping (IABP). 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,
AB - Background: The use of Extracorporeal Membrane Oxygenation (ECMO) remains associated with high rates of complications, weaning failure and mortality which can be partly explained by a knowledge gap on how to properly manage patients on ECMO support. To address relevant patient management issues, we designed a “Randomized Embedded Multifactorial Adaptive Platform (REMAP)” in the setting of ECMO (REMAP ECMO) and a first embedded randomized controlled trial (RCT) investigating the effects of routine early left ventricular (LV) unloading through intra-aortic balloon pumping (IABP). 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,
UR - http://www.scopus.com/inward/record.url?scp=85209243148&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2024.10.010
DO - 10.1016/j.ahj.2024.10.010
M3 - Article
C2 - 39447716
SN - 0002-8703
VL - 279
SP - 81
EP - 93
JO - American Heart Journal
JF - American Heart Journal
ER -