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

使用 O 组全血或产品进行 1/2 创伤复苏 (TROOP) 试验

• 批准号: 10449760
• 负责人: John B Holcomb
• 金额: $ 168.04万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-05 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10449760
• 关键词: Accounting; Adult; Affect; Age; Alabama; Anticoagulants; Benefits and Risks; Blood; Blood Coagulation Disorders; Blood Donations; Blood Platelets; Blood Transfusion; Blood Volume; Cardiac; Cause of Death; Cessation of life; Child; Clinical; Clinical Trials; Clinical effectiveness; Collaborations; Critical Care; Critical Illness; Data; Data Coordinating Center; Early treatment; Effectiveness; Emergency Care; Enrollment; Erythrocytes; Funding; Grant; Health Sciences; Heart Diseases; Hemorrhage; Hemorrhagic Shock; Hospitals; Hour; Incidence; Injury; Knowledge; Leadership; Life; Lung; Malignant Neoplasms; Military Personnel; Modernization; Multicenter Trials; National Heart, Lung, and Blood Institute; Observational Study; Outcome; Patients; Phase; Plasma; Population; Positioning Attribute; Public Health Schools; Randomized; Randomized Clinical Trials; Recommendation; Research; Research Personnel; Resources; Resuscitation; Retrospective Studies; Safety; Sample Size; Savings; Science; Shock; Testing; Texas; Transfusion; Trauma; Trauma patient; Traumatic Hemorrhage; Traumatic injury; United States; Universities; Use Effectiveness; Whole Blood; age group; base; blood product; clinical practice; compare effectiveness; cost; cost effectiveness; design; experience; feasibility trial; improved; innovation; mortality; multidisciplinary; novel; platelet function; practice setting; preventable death; primary outcome; reconstitution; severe injury; standard of care; trauma care; trauma centers

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.

项目概要 本申请适用于“O 组全血或产品创伤复苏”(TROOP) 试验， 务实、多中心、III期随机临床试验，评估临床有效性和安全性 与成分血治疗相比，全血预计需要大量的创伤患者 输血。 创伤是美国的主要原因之一，并且不成比例地影响年轻人、 杀死那些本来可以长寿且富有成效的人的伤害导致了更多年的潜在寿命。 75 岁之前死亡的原因中，出血仍然是可预防死亡的最常见原因。 受伤后，输血是现代血库治疗的重要组成部分。 当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（浓缩红细胞、血浆和血小板）， 尝试有效地重建全血是创伤输血治疗的一种新方法。 从一开始就使用全血，与成分疗法相比，全血没有被分离。 血液提供了一些潜在的优势，但只有少数研究，大部分是观察性的研究 比较全血和成分疗法，它们的 TROOP 会随机分配。 符合条件的患者可以接受全血复苏或成分治疗（当前的护理标准）。 该试验采用了高度创新的贝叶斯、分组序贯、组合的非劣效性/优效性设计。 与 NHLBI 的创新临床试验资源合作设计，由 U34 规划拨款资助 (U34HL148472)。根据最近的专家建议，主要结果是 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，该试验将有 85% 的功效。 确定非劣势，80% 的力量确定优势 我们聚集了一支经验丰富的团队。 由在此类临床研究中具有重要且互补专业知识的研究人员组成的团队。 协调中心设在伯明翰阿拉巴马大学损伤科学中心， 数据协调中心位于德克萨斯大学健康科学分校公共卫生学院 休斯顿中心。 从这项临床试验中获得的知识将改变大出血创伤患者的治疗方式 TROOP 非常有能力降低创伤死亡率并减少死亡人数。 失血性休克导致的可预防的死亡。

项目成果

What does professionalism really mean in the contemporary surgical landscape?

专业精神在当代外科领域真正意味着什么？

• DOI: 10.1503/cjs.001524
• 发表时间: 2024
• 期刊: Canadian journal of surgery. Journal canadien de chirurgie
• 作者: Ball,ChadG;Inaba,Kenji;Harvey,EdwardJ
• 通讯作者: Harvey,EdwardJ