2/2 Trauma Resuscitation with Group O Whole Blood or Products (TROOP)

项目总结 在与阿拉巴马大学(UAB)的合作下，我们提议进行为期五年的 O型全血或产品复苏“(STROAM)试验，务实，多中心，第三阶段 评价全血临床有效性和安全性的随机临床试验，与 创伤患者的成分血液疗法预计需要大量输血。 军队试验的主要假设是，接受全血治疗的那组人不会表现得更差 死亡率和/或死亡率低于6小时内的成分疗法。这场审判的理由是 尽管目前创伤输血的护理标准是平衡地给予同等数量的 血液成分单位(包装红细胞、血浆和血小板)，目前有123个美国创伤中心 使用LTOWB进行创伤复苏。因此，创伤输血治疗的新方法是 从一开始就使用全血。与成分疗法相比，全血输血有几个优点 后勤和潜在的临床优势；然而，只有少数观察性研究 他们比较了这两种策略。部队试验临床协调中心(CCC)的具体目标 UAB提交的申请是：(1)确定全血疗法与成分疗法的有效性 危重患者的6小时；以及2)评估全血治疗与成分治疗的安全性 通过评估较长期的终点：24小时、30天和主要并发症。 为了评估这些特定的目标，试验使用了高度创新的、贝叶斯的、分组顺序的、组合的非 劣势/优势设计，预案成本效益分析。这项试验是在 与NHLBI的创新临床试验资源合作，由U34规划拨款(U34HL148472)资助。 UAB随附的CCC申请描述了临床背景和基本原理的细节 研究、资格标准、治疗和后续程序以及部队的组织结构。 大学生物统计与数据科学系临床试验协调中心 休斯顿的德克萨斯健康科学中心将作为统计和数据协调中心(DCC) 军队审判。这份DCC申请描述了部队试验的目标、DCC的专业知识、它在 部队试验，数据处理和管理的细节，以及贝叶斯统计的细节设计、分析 计划，以及潜在的陷阱。

PROJECT SUMMARY In collaboration with the University of Alabama (UAB), we propose to conduct the five-year, “Trauma Resuscitation with Group O Whole Blood Or Products” (TROOP) trial, a pragmatic, multicenter, phase III randomized clinical trial to evaluate the clinical effectiveness and safety of whole blood, compared with component blood therapy in trauma patients predicted to require large volume blood transfusions. The primary hypothesis of the TROOP trial is that the group treated with whole blood will exhibit no worse mortality and/or lower mortality compared to component therapy at 6 hours. The rationale for this trial is that although the current standard of care in trauma transfusion is the balanced administration of equal numbers of units of blood components (packed red blood cells, plasma, and platelets), 123 U.S. trauma centers currently use LTOWB for trauma resuscitation. Thus, a renewed approach to blood transfusion therapy in trauma is to use whole blood from the outset. Compared with component therapy, transfusion with whole blood offers several logistical and potentially clinical advantages; however, there are only a small number of observational studies that have compared the strategies. The specific aims of the TROOP trial clinical coordinating center (CCC) application submitted by UAB are to: (1) determine the effectiveness of whole blood versus component therapy at 6 hours in critically injured patients; and 2) evaluate the safety of whole blood compared to component therapy by evaluating longer term endpoints: 24 hours, 30 days, and major complications. To assess these specific aims, the trial uses a highly innovative, Bayesian, group-sequential, combined non- inferiority/superiority design, and pre-planned cost-effectiveness analysis. The trial has been designed in collaboration with NHLBI’s Innovative Clinical Trials Resource, funded by a U34 Planning Grant (U34HL148472). The accompanying CCC application from UAB describes the details of the clinical background and rationale for the study, eligibility criteria, treatment and follow-up procedures, and the organizational structure of TROOP. The Coordinating Center for Clinical Trials in the Department of Biostatistics and Data Science at the University of Texas Health Science Center at Houston will serve as the statistical and data coordination center (DCC) for the TROOP Trial. This DCC application describes the TROOP trial aims, expertise of the DCC, its role in the TROOP trial, details of data processing and management, and details of the Bayesian statistical design, analysis plan, and potential pitfalls.