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

项目摘要 此应用程序用于“O型全血或产品创伤复苏”（TROOP）试验， 一项实用的、多中心的、III期随机临床试验，以评价 与成分血治疗相比，预计需要大量全血的创伤患者 输血 创伤是美国死亡的主要原因之一，对年轻人的影响不成比例， 杀害那些本来可以长寿和富有成效的人。受伤占更多年的潜力 75岁之前的死亡率高于其他任何原因。出血仍然是可预防死亡的最常见原因 受伤后，输血是治疗的重要组成部分。现代血库的做法 捐献的全血制成成分。目前创伤输血的护理标准是 给予等量单位的血液成分（浓缩红细胞、血浆和血小板）， 有效地尝试重组全血。创伤输血治疗的新方法是 从一开始就使用未经分离的全血。与成分疗法相比，整体疗法 血液提供了几个潜在的优势，但只有少数，主要是观察性的研究， 比较全血和成分疗法，它们是非常异质的。部队将随机分配 符合条件的患者接受全血复苏或成分治疗（当前的护理标准）。审判 使用高度创新的贝叶斯、组序贯、非劣效性/优效性组合设计。审判 与NHLBI的创新临床试验资源合作设计，由U34规划补助金资助 （U34HL148472）。根据最近的专家建议，主要结局将是6小时死亡率。 TROOP将在12个一级创伤中心招募1,100名患者，为期36个月。试验将有85%的把握 确定非劣效性，80%把握度确定优效性。我们召集了一位经验丰富的 在这类研究中具有重要和互补专业知识的研究人员团队。临床 协调中心设在伯明翰的亚拉巴马大学伤害科学中心， 数据协调中心位于德克萨斯大学健康科学学院的公共卫生学院 休斯顿中心。 从这项临床试验中获得的知识将改变大量出血的创伤患者 都输了血部队是非常好的定位，以提高死亡率从创伤，并减少数量 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.