van Minnen Olivier, Linde Maximilian, Oude Lansink-Hartgring Annemieke, van den Boogaard Bas, Bunge Jeroen J H, Delnoij Thijs S R, Elzo Kraemer Carlos V, Kuijpers Marijn, Maas Jacinta J, de Metz Jesse, van de Poll Marcel, Dos Reis Miranda Dinis, Vlaar Alexander P J, van Ravenzwaaij Don, van den Bergh Walter M
Department of Critical Care, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
GESIS - Leibniz Institute for the Social Sciences, Cologne, Germany.
Trials. 2025 Mar 15;26(1):90. doi: 10.1186/s13063-025-08737-6.
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.
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.
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.
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).
RATE试验是一项三臂非劣效性随机对照试验，针对接受体外膜肺氧合（ECMO）治疗的成年患者，研究抗凝水平对死亡率、出血和血栓形成并发症的影响。本方案介绍了在贝叶斯框架下评估主要和次要结局的基本原理及分析计划。
本方案在研究完成前，即主要分析之前起草并提交。贝叶斯分析的主要结局是6个月时的死亡率。次要结局是严重出血和血栓形成并发症。主要分析将使用无信息先验。敏感性分析将使用怀疑先验和基于证据的信息先验进行。
提议对RATE试验进行预先计划的二次贝叶斯分析，将提供关于ECMO期间不同抗凝策略对并发症发生率影响的更多信息。这一额外的贝叶斯分析可能会提高我们结果的有效性，并补充对主要和几个次要结局的解释。
本试验已在https://clinicaltrials.gov/（NCT04536272）注册，注册日期为2020年9月2日。本试验也已在荷兰试验注册中心（NL7976）注册。
