Reduced anticoagulation targets in extracorporeal life support (RATE): protocol for a pre-planned secondary Bayesian analysis of the rate trial.

IF 2 4区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Trials Pub Date : 2025-03-15 DOI:10.1186/s13063-025-08737-6

Olivier van Minnen, Maximilian Linde, Annemieke Oude Lansink-Hartgring, Bas van den Boogaard, Jeroen J H Bunge, Thijs S R Delnoij, Carlos V Elzo Kraemer, Marijn Kuijpers, Jacinta J Maas, Jesse de Metz, Marcel van de Poll, Dinis Dos Reis Miranda, Alexander P J Vlaar, Don van Ravenzwaaij, Walter M van den Bergh

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引用次数: 0

Abstract

Background: The RATE trial is a three-arm non-inferiority randomized controlled trial in adult patients treated with extracorporeal membrane oxygenation (ECMO) on the effect of anticoagulation levels on mortality, hemorrhagic, and thrombotic complications. The current protocol presents the rationale and analysis plan for evaluating the primary and secondary outcomes under the Bayesian framework.

Methods: This protocol was drafted and submitted before study completion and, thus, the primary analysis. The primary outcome of the Bayesian analysis is mortality at 6 months. The secondary outcomes are severe hemorrhagic and thrombotic complications. We will use an uninformative prior for the primary analysis. Sensitivity analyses will be performed using a skeptical prior and an evidence-based informative prior.

Conclusion: The proposed secondary, pre-planned Bayesian analysis of the RATE trial will provide additional information on the effect of different anticoagulation strategies during ECMO on complication rates. This additional Bayesian analysis will likely increase the validity of our results and complement the interpretation of the primary and several secondary outcomes.

Trial registration: This trial is registered at https://clinicaltrials.gov/ (NCT04536272), registration date September 2, 2020. This trial is also registered at the Dutch trial register (NL7976).

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体外生命支持（RATE）中抗凝目标降低：速率试验的预先计划的二次贝叶斯分析方案。

背景：RATE试验是一项三组非劣效性随机对照试验，在接受体外膜氧合（ECMO）治疗的成年患者中进行，研究抗凝水平对死亡率、出血和血栓并发症的影响。目前的方案提出了在贝叶斯框架下评估主要和次要结果的基本原理和分析计划。方法：本方案是在研究完成前起草并提交的，因此是初步分析。贝叶斯分析的主要结果是6个月时的死亡率。次要结果是严重的出血和血栓并发症。我们将使用无信息先验进行初步分析。敏感性分析将使用怀疑先验和基于证据的信息先验进行。结论：对RATE试验提出的二次、预先计划的贝叶斯分析将为ECMO期间不同抗凝策略对并发症发生率的影响提供额外的信息。这个额外的贝叶斯分析可能会增加我们结果的有效性，并补充对主要结果和几个次要结果的解释。试验注册：该试验注册于https://clinicaltrials.gov/ (NCT04536272)，注册日期为2020年9月2日。该试验也在荷兰试验注册（NL7976）上注册。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Trials 医学-医学：研究与实验

CiteScore

3.80

自引率

4.00%

发文量

966

审稿时长

6 months

期刊介绍： Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.