Trauma Resuscitation with Group O Whole Blood Or Products (TROOP) Trial

项目摘要 此U34应用程序用于规划未来的临床试验“O组整体创伤复苏” 血液或产品”（部队）。这项建议的首要目标是使联合国系统的统计设计成熟， TROOP试验，并开发进行试验所需的研究基础设施。我们的努力将是 并辅之以NIH创新临床试验资源的指导和投入。这些努力将导致 用于未来的NIH应用程序，以支持大型多中心临床试验。 出血（出血）是受伤后可预防死亡的最常见原因。治疗出血 需要手术（止血）和补充失血。为了让捐献的血液 为多个病人服务，现代血库的做法是将供体血液分离成多种成分（红色）。 血细胞、血浆和血小板）。然而，严重受伤的患者需要所有这些组件。军事 在伊拉克和阿富汗战争中的经验，创新了使用未分离的全血， 失血性休克复苏虽然比分离血液更简单， 产品，全血或成分血在出血性休克的情况下的益处尚不清楚。我们 目的是进行一项多中心临床试验（TROOP），比较全血与常规分离的 成分血在创伤失血性休克复苏中的应用我们建议使用贝叶斯群- 本研究的序贯设计更好地利用了现有信息，需要的患者更少， 更快地提供答案。贝叶斯设计是创新的，但也更复杂，需要更多的 计划和准备比常规试验。我们还计划纳入成本效益分析， 评估干预措施的价值。 规划阶段的关键任务包括改进贝叶斯设计、征求专家意见 支持贝叶斯先验概率估计、基线成本数据收集、医院招聘， 参与试验，开发数据收集基础设施，与食品药品监督管理局（FDA） 管理和临床试验方案的制定。 TROOP试验将需要伯明翰的亚拉巴马大学和 德克萨斯大学休斯顿健康科学中心。这项努力将联合创伤外科专家， 护理、急诊医学、生物统计学、卫生经济学和试验方法学。获得的知识 将直接影响平民和军事创伤护理，确定最佳方法， 严重创伤患者的输血治疗。

PROJECT SUMMARY This U34 application is for the planning of a future clinical trial “Trauma Resuscitation with Group O Whole Blood Or Products” (TROOP). The overarching aims of this proposal are to mature the statistical design of the TROOP trial, and to develop the research infrastructure required to carry out the trial. Our efforts will be complemented by guidance and input from the NIH Innovative Clinical Trials Resource. These efforts will lead to a future NIH application to support a large multicenter clinical trial. Bleeding (hemorrhage) is the most common cause of preventable death after injury. Treatment of bleeding requires both surgery (to stop the bleeding) and replacement of lost blood. In order to allow donated blood to serve multiple patients, modern blood banking practices separate donor blood into multiple components (red blood cells, plasma, and platelets). However, severely injured patients require all of these components. Military experience during the wars in Iraq and Afghanistan have innovated the use of whole unseparated blood in resuscitation of hemorrhagic shock. While simpler and potentially more effective than separated blood products, the benefit of whole blood or component blood in the setting of hemorrhage shock is unknown. We aim to carry out a multicenter clinical trial (TROOP) comparing whole blood vs conventional separated component blood in the resuscitation of traumatic hemorrhagic shock. We propose to use a Bayesian group- sequential design for this study, which makes better use of existing information, requires fewer patients, and provides answers more quickly. Bayesian designs are innovative, but also more complex, and require more planning and preparation than conventional trials. We also plan to incorporate a cost-effectiveness analysis to assess the value of the interventions. Key tasks during the planning phase will include refinement of the Bayesian design, elicitation of expert opinion to support Bayesian prior probability estimates, collection of baseline cost data, recruitment of hospitals to participate in the trial, development of data collection infrastructure, interface with the Food and Drug Administration, and development of the clinical trial protocol. The TROOP trial will entail a collaborative effort between the University of Alabama at Birmingham, and the University of Texas Health Science Center at Houston. The effort will unite experts in trauma surgery, critical care, emergency medicine, biostatistics, health economics, and trials methodology. The knowledge gained from the TROOP trial would directly impact civilian and military trauma care, identifying the optimal approach to blood transfusion therapy in severely injured patients.