1/2 Trauma Resuscitation with Group O Whole Blood Or Products (TROOP) Trial

项目总结 本申请为“O型全血或产品创伤复苏”(STROAM)试验，a 实用型、多中心、III期随机临床试验，评价阿昔洛韦的临床疗效和安全性 全血与成分血疗法相比，在预计需要大容量的创伤患者中 输血。 创伤是美国主要的死亡原因之一，对年轻人的影响不成比例， 杀死那些本来可以长寿多产的人。受伤可能导致更多年的潜在死亡 75岁之前失去的生命比其他任何原因都要多。出血仍然是可预防死亡的最常见原因 受伤后，输血是治疗必不可少的一部分。现代血库做法分开 把全血都捐献成血液成分。目前创伤输血的护理标准是平衡的 给予等量单位的血液成分(包装的红细胞、血浆和血小板)， 有效地试图重建全血。创伤输血治疗的新方法是 从一开始就使用全血，这是没有被分离的。与部件疗法相比，整体 血液提供了几个潜在的优势，但只有少数研究，主要是观察性的 比较全血疗法和成分疗法，它们是非常不同的。部队将随机分配 符合条件的患者可以接受全血复苏或成分疗法(目前的护理标准)。这场审判 采用高度创新、贝叶斯、分组顺序、非劣势/优势相结合的设计。审判已经进行了 与NHLBI的创新临床试验资源合作设计，由U34规划拨款资助 (U34HL148472)。根据最近专家的建议，主要结果将是6小时死亡。 军队将在12个I级创伤中心招募1100名患者，为期36个月。审判将有85%的权力 确定非劣势，80%的力量决定优势。我们集结了一支经验丰富的 在这类研究方面具有重要和互补专业知识的调查团队。《临床》 协调中心设在阿拉巴马大学伯明翰分校的伤害科学中心， 数据协调中心的总部设在德克萨斯大学公共卫生学院 休斯顿中心。 从这项临床试验中获得的知识将改变创伤患者大量出血的方式 都被输血了。军队处于非常有利的地位，可以提高创伤死亡率，减少死亡人数 失血性休克导致的可预防的死亡。

PROJECT SUMMARY This application is for the “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. Trauma is one of the leading causes of death in the United States, and disproportionately affects the young, killing those who might otherwise have lived long and productive lives. Injuries account for more years of potential life lost before 75 than any other cause. Hemorrhage remains the most common cause of preventable death after injury, and blood transfusion is an essential part of treatment. Modern blood banking practices separate donated whole blood into components. 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), effectively attempting to reconstitute whole blood. A renewed approach to blood transfusion therapy in trauma is to use whole blood from the outset, which has not been separated. Compared with component therapy, whole blood offers several potential advantages, but there are only a small number of, mostly observational, studies comparing whole blood and component therapy, and they are very heterogeneous. TROOP will randomly assign eligible patients to either whole blood resuscitation or component therapy (the current standard of care). The trial uses a highly innovative, Bayesian, group-sequential, combined non-inferiority/superiority design. The trial has been designed in collaboration with NHLBI’s Innovative Clinical Trials Resource, funded by a U34 Planning Grant (U34HL148472). In keeping with recent expert recommendations, the primary outcome will be 6-hour mortality. TROOP will enroll 1,100 patients, over 36 months, at 12 level I trauma centers. The trial will have 85% power to determine non-inferiority, and 80% power to determine superiority. We have assembled a highly experienced team of investigators with significant and complementary expertise in this type of research. The Clinical Coordinating Center is based in the Center for Injury Science at the University of Alabama at Birmingham, and the Data Coordinating Center is based in the School of Public Health, at the University of Texas Health Science Center at Houston. The knowledge gained from this clinical trial will transform the way in which massively bleeding trauma patients are transfused. TROOP is exceedingly well positioned to improve mortality from trauma, and reduce the number of preventable deaths resulting from hemorrhagic shock.