体外膜氧合的随机嵌入式多因素自适应平台（REMAP ECMO）--左心室减压试验领域的设计与原理。

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal Pub Date : 2024-10-22 DOI:10.1016/j.ahj.2024.10.010

Myrthe P.J. van Steenwijk MD , Joost van Rosmalen PhD , Carlos V. Elzo Kraemer MD , Dirk W. Donker MD, PhD , Jeannine A.J.M. Hermens MD , Adriaan O. Kraaijeveld MD, PhD , Jacinta J. Maas MD, PhD , Sakir Akin MD, PhD , Leon J. Montenij MD, PhD , Alexander P.J. Vlaar MD, PhD , Walter M. van den Bergh MD, PhD , Annemieke Oude Lansink-Hartgring MD, PhD , Jesse de Metz MD , Niek Voesten MD , Eric Boersma PhD , Erik Scholten MD, PhD , Albertus Beishuizen MD, PhD , Chris P.H. Lexis MD, PhD , Harlinde Peperstraete MD, PhD , Simon Schiettekatte MD, PhD , Christiaan L. Meuwese MD, PhD

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引用次数: 0

摘要

背景：体外膜氧合（ECMO）的使用仍与高并发症发生率、断奶失败率和死亡率有关，而这在一定程度上是因为在如何正确管理 ECMO 支持患者方面存在知识差距。为了解决相关的患者管理问题，我们在 ECMO（REMAP ECMO）环境中设计了一个 "随机嵌入式多因素自适应平台（REMAP）"，并设计了首个嵌入式随机对照试验（RCT），调查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，该平台允许嵌入多个反应适应性 RCT（试验域），可持续解决相关患者管理问题对 ECMO 断流成功率的影响。第一个试验领域研究的是在重症监护室（ICU）收治的成人心源性休克患者中，通过 IABP 辅助静脉-动脉（V-A）ECMO 给左心室减压与单独使用 V-A ECMO 相比，对 30 天后 ECMO 断流成功率的影响。这项试验的主要结果是 "ECMO 成功断流"，即在开始使用 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) 而存活的综合结果。次要结果包括是否需要介入性升级左心室减压策略、机理终点、启动 ECMO 一年后的存活特征以及生活质量。试验数据将采用贝叶斯统计框架进行分析。自适应设计允许高度的灵活性，如响应自适应随机化和因疗效或无效而提前终止试验。REMAP ECMO LV 卸载研究已获得伊拉斯姆斯医学中心医学伦理委员会的批准，并已公开注册：结论：REMAP ECMO 试验平台可就相关的患者管理问题高效地推出多项 RCT。第一个嵌入式试验领域将通过 IABP 作为 V-A ECMO 的辅助手段，比较常规 LV 负荷与单独 V-A ECMO：试验注册：ClinicalTrials.gov，NCT05913622。

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A randomized embedded multifactorial adaptive platform for extra corporeal membrane oxygenation (REMAP ECMO) – design and rationale of the left ventricular unloading trial domain

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, NCT05913622

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来源期刊

American heart journal 医学-心血管系统

CiteScore

8.20

自引率

2.10%

发文量

214

审稿时长

38 days

期刊介绍： The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.