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

2/2 使用 O 组全血或产品进行创伤复苏 (TROOP)

基本信息

批准号：
10449778
负责人：
Stacia DeSantis
金额：
$ 65.38万
依托单位：
UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-08-05 至 2027-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10449778
关键词：
Accident and Emergency department Adverse event Alabama Annual Reports Biometry Blood Blood Platelets Blood Transfusion Blood Volume Budgets Case Report Form Cessation of life Clinical Clinical Data Clinical Management Clinical Trials Clinical Trials Data Monitoring Committees Clinical effectiveness Collaborations Collection Communication Communities Complement Conflict of Interest Cost Effectiveness Analysis Data Data Collection Data Coordinating Center Data Science Data Set Development Documentation Elements Eligibility Determination Enrollment Ensure Erythrocytes Event Exhibits Funding Goals Grant Health Sciences Hemorrhagic Shock Hour Human Resources Institutional Review Boards Leadership Logistics Manuals Methodology Monitor National Heart, Lung, and Blood Institute Observational Study Patients Phase Plasma Policies Positioning Attribute Principal Investigator Probability Procedures Protocols documentation Publications Quality Control Randomized Clinical Trials Reporting Research Resources Resuscitation Role Safety Schedule Secure Site Specific qualifier value System Testing Texas Time TimeLine Transfusion Trauma Trauma patient United States Food and Drug Administration Universities Validation Voting Whole Blood authority clinical center compare effectiveness computerized data processing data dissemination data management design effectiveness evaluation electronic data electronic data capture system experience follow-up improved innovation meetings member mortality operation organizational structure primary outcome recruit remote monitoring secondary outcome severe injury standard of care symposium transfusion medicine trauma centers trial design web site working group

项目摘要

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.

项目概要我们与阿拉巴马大学 (UAB) 合作，建议开展为期五年的“创伤使用 O 组全血或产品进行复苏”（TROOP）试验，一项务实的、多中心的 III 期试验评估全血临床有效性和安全性的随机临床试验，与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，接受全血治疗的组不会表现出更差的情况与 6 小时的成分治疗相比，死亡率和/或更低的死亡率本试验的基本原理是：尽管目前创伤输血的护理标准是均衡管理同等数量的输血血液成分单位（浓缩红细胞、血浆和血小板），目前有 123 个美国创伤中心使用 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，输注全血具有多种优势。后勤和潜在的临床优势；然而，只有少量的观察性研究 TROOP 试验临床协调中心 (CCC) 的具体目标 UAB 提交的申请旨在： (1) 确定全血与成分疗法的有效性在重伤患者中 6 小时；2) 评估全血与成分疗法相比的安全性通过评估长期终点：24 小时、30 天和主要并发症。为了评估这些具体目标，该试验使用了高度创新的贝叶斯、组序、组合非劣效/优效设计以及预先计划的成本效益分析。与 NHLBI 的创新临床试验资源合作，该资源由 U34 规划补助金 (U34HL148472) 资助。 UAB 随附的 CCC 申请描述了临床背景和基本原理的详细信息研究、标准资格、治疗和随访程序以及 TROOP 的组织结构。大学生物统计与数据科学系临床试验协调中心位于休斯顿的德克萨斯健康科学中心将作为统计和数据协调中心（DCC）该 DCC 申请描述了 TROOP 试验的目的、DCC 的专业知识及其在该试验中的作用。 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。