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

项目摘要 在与亚拉巴马大学（UAB）合作，我们建议进行为期五年的“创伤”， “O型全血或制品复苏”（TROOP）试验，一项实用的多中心III期临床试验 随机临床试验，以评价全血的临床有效性和安全性， 预计需要大量输血的创伤患者的成分血液治疗。 TROOP试验的主要假设是，用全血治疗的组不会表现出更差的 死亡率和/或6小时时与成分治疗相比死亡率更低。这项试验的基本原理是， 尽管目前创伤输血的护理标准是平衡施用等量的 单位的血液成分（浓缩红细胞，血浆和血小板），123美国创伤中心目前 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，全血输注提供了几个 后勤和潜在的临床优势;然而，只有少数观察性研究 比较了不同的策略TROOP试验临床协调中心（CCC）的具体目标 UAB提交的申请旨在：（1）确定全血与成分治疗的有效性 在危重患者中6小时;和2）评价全血与成分治疗相比的安全性 通过评价长期终点：24小时、30天和主要并发症。 为了评估这些具体目标，该试验使用了一种高度创新的、贝叶斯的、组序贯的、组合的非 劣效/优效设计和预先计划的成本效益分析。该试验设计于 与NHLBI的创新临床试验资源合作，由U34规划补助金（U34 HL 148472）资助。 UAB随附的CCC申请描述了临床背景和理由的详细信息， 研究，资格标准，治疗和随访程序，以及TROOP的组织结构。 该大学生物统计和数据科学系临床试验协调中心 德克萨斯州健康科学中心将作为统计和数据协调中心（DCC）， 军队审判该DCC申请描述了TROOP试验的目的，DCC的专业知识，其在 TROOP试验，数据处理和管理的细节，以及贝叶斯统计设计、分析的细节 计划和潜在的陷阱。

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.