Lammers Daniel, Rokayak Omar, Uhlich Rindi, Sensing Thomas, Baird Emily, Richman Joshua, Holcomb John B, Jansen Jan
Division of Trauma and Acute Care Surgery, The University of Alabama at Birmingham Hospital, Birmingham, Alabama, USA.
Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Trauma Surg Acute Care Open. 2023 Aug 9;8(1):e001091. doi: 10.1136/tsaco-2023-001091. eCollection 2023.
The Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) trial failed to demonstrate a mortality difference for hemorrhaging patients receiving a balanced (1:1:1) vs a 1:1:2 resuscitation at 24 hours and 30 days. Recent guidelines recommend earlier mortality end points for hemorrhage-control trials, and the use of contemporary statistical methods. The aim of this post hoc analysis of the PROPPR trial was to evaluate the impact of a balanced resuscitation strategy at early resuscitation time points using a Bayesian analytical framework.
Bayesian hierarchical models were created to assess mortality differences at the 1, 3, 6, 12, 18, and 24 hours time points between study cohorts. Posterior probabilities and Bayes factors were calculated for each time point.
A 1:1:1 resuscitation displayed a 96%, 99%, 94%, 92%, 96%, and 94% probability for mortality benefit at 1, 3, 6, 12, 18, and 24 hours, respectively, when compared with a 1:1:2 approach. Associated Bayes factors for each respective time period were 21.2, 142, 14.9, 11.4, 26.4, and 15.5, indicating 'strong' to 'decisive' supporting evidence in favor of balanced transfusions.
This analysis provides evidence in support that a 1:1:1 resuscitation has a high probability of mortality benefit when compared with a 1:1:2 strategy, especially at the newly defined more proximate time points during the resuscitative period. Researchers should consider using Bayesian approaches, along with more proximate end points when assessing hemorrhage-related mortality, for the analysis of future clinical trials.
Level III/Therapeutic.
实用随机优化血小板与血浆比例（PROPPR）试验未能证明出血患者在24小时和30天时接受平衡（1:1:1）与1:1:2复苏的死亡率存在差异。近期指南建议在出血控制试验中采用更早的死亡率终点，并使用当代统计方法。这项对PROPPR试验的事后分析旨在使用贝叶斯分析框架评估早期复苏时间点平衡复苏策略的影响。
创建贝叶斯分层模型，以评估研究队列在1、3、6、12、18和24小时时间点的死亡率差异。计算每个时间点的后验概率和贝叶斯因子。
与1:1:2的复苏方法相比，1:1:1复苏在1、3、6、12、18和24小时时死亡率获益的概率分别为96%、99%、94%、92%、96%和94%。每个相应时间段的相关贝叶斯因子分别为21.2、142、14.9、11.4、26.4和15.5，表明支持平衡输血的证据为“强”到“决定性”。
该分析提供的证据支持，与1:1:2策略相比，1:1:1复苏有很高的死亡率获益概率，尤其是在复苏期新定义的更近时间点。研究人员在评估与出血相关的死亡率时，应考虑使用贝叶斯方法以及更近的终点，用于未来临床试验的分析。
III级/治疗性。
