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
Department of Intensive Care, Erasmus Medical Center, Rotterdam, the Netherlands; Department of Cardiology, Thorax Center, Cardiovascular Institute, Erasmus Medical Center, Rotterdam, the Netherlands.
Departments of Biostatistics, Erasmus Medical Center, Rotterdam, the Netherlands; Department of Epidemiology, Erasmus Medical Center, Rotterdam, The Netherlands.
Am Heart J. 2025 Jan;279:81-93. doi: 10.1016/j.ahj.2024.10.010. Epub 2024 Oct 22.
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).
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.
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.
ClinicalTrials.gov, NCT05913622.
体外膜肺氧合（ECMO）的使用仍然伴随着高并发症发生率、撤机失败率和死亡率，这在一定程度上可以通过对如何妥善管理接受ECMO支持的患者的知识差距来解释。为了解决相关的患者管理问题，我们在ECMO环境中设计了一个“随机嵌入式多因素自适应平台（REMAP）”（REMAP ECMO）以及第一项嵌入式随机对照试验（RCT），以研究通过主动脉内球囊反搏（IABP）进行常规早期左心室（LV）卸载的效果。
REMAP ECMO描述了一个基于注册的平台，允许嵌入多个反应自适应RCT（试验域），这些试验域可以持续解决相关患者管理问题对ECMO撤机成功的影响。第一个试验域研究在入住重症监护病房（ICU）的成年心源性休克患者中，IABP作为静脉-动脉（V-A）ECMO的辅助手段进行LV卸载与单独使用V-A ECMO相比，对30天时ECMO撤机成功的影响。该试验的主要结局是“成功从ECMO撤机”，定义为在启动ECMO后30天内无需机械循环支持、心脏移植或左心室辅助装置（LVAD）即可存活的综合情况。次要结局包括LV卸载策略的介入升级需求、机制性终点、ECMO启动后直至1年的生存特征以及生活质量。试验数据将使用贝叶斯统计框架进行分析。自适应设计具有高度灵活性，例如反应自适应随机化以及为了有效性或无效性而提前终止试验。REMAP ECMO LV卸载研究已获得伊拉斯谟医学中心医学伦理委员会的批准并已公开注册。
这个REMAP ECMO试验平台能够高效开展多项关于相关患者管理问题的RCT。第一个嵌入式试验域将比较IABP作为V-A ECMO辅助手段进行常规LV卸载与单独使用V-A ECMO的效果。
ClinicalTrials.gov，NCT05913622。
