Resuscitation Outcomes Consortium (ROC) Data Coordinating Center

复苏结果联盟 (ROC) 数据协调中心

• 批准号: 8265788
• 负责人: Susanne May
• 金额: $ 1460.2万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-01 至 2015-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8265788
• 关键词: Accident and Emergency department; Adherence; Admission activity; Adult; Biological Assay; Biological Markers; Blinded; Blood Coagulation Disorders; Blood Platelets; Blood specimen; Cessation of life; Clinical; Clinical Trials Design; Coagulation Process; Data; Data Coordinating Center; Data Quality; Eligibility Determination; Emergency Situation; Enrollment; Erythrocytes; Exhibits; Goals; Health Sciences; Hemorrhage; Hemorrhagic Shock; Hospitals; Hour; Inflammation; Inflammatory; Informed Consent; Injury; Knowledge; Laboratories; Life; Measures; Modeling; Monitor; Natural History; Outcome; Patients; Phase; Phase III Clinical Trials; Phenotype; Plasma; Population; Principal Investigator; Probability; Process; Protocols documentation; Public Health Schools; Randomized; Reporting; Resuscitation; Safety; Sampling; Serious Adverse Event; Shock; Side; Site; Staging; Systems Biology; Testing; Texas; Time; Transfusion; Trauma; Universities; Washington; Whole Blood; arm; base; blood product; clinical research site; design; inflammatory marker; interest; medical schools; meetings; mortality; primary outcome; prospective; randomized trial; reconstitution; time interval; trauma centers

DESCRIPTION (provided by applicant): The Resuscitation Outcomes Consortium (ROC) will conduct the Prospective, Randomized, Optimal Platelet and Plasma Ratios (PROPPR) Phase III trial to compare 24-hour and 30-day mortality (co-primary outcomes) in 580 subjects receiving differing blood product ratios. Subjects in PROPPR must meet eligibility criteria and be predicted to receive a massive transfusion (MT) within 24 hours of emergency admission to a Level I Adult Trauma Center. The trial begins with a Vanguard Stage (120 subjects) conducted in at least four sites to study two ratios (1:1:2, 1:1:3, plasma:platelets:RBCs) and choose the better arm to carry forward into Phase III to compare to 1:1:1. The closest equivalent to whole blood. 40 subjects per arm, provide 83% probability of correctly choosing the better arm. In the Vanguard Stage, we will assess protocol safety, feasibility and begin study of trauma induced coagulopathy (TIC) and inflammatory markers. In Phase III, 580 total subjects (including 80 from the Vanguard Stage), provide 90% power to detect a difference of 10% or more in 24-hour mortality and 88% power to detect a difference of 12% or more in 30-day mortality, assuming each alpha=0.044, two-sided test, and 11% 24-hour mortality and 23% 30-day mortality in the 1:1:1 group. Mantel-Haenszel tests will be used with site as a stratifying variable. We will describe mechanistic drivers and sequelae of TIC and inflammation, and characterize the natural history of the coagulation milieu with resuscitation after severe injury in randomized patients. Given the life-threatening situation and the prospect of benefit in each treatment arm, exception from informed consent will be used. Susanne May, ROC Data Coordinating Center (DCC), is the Principal Investigator (PI) of contact. Gerald van Belle, DCC, is the PI-PROPPR. John Holcomb is PI of the UTHealth Clinical Coordinating Center, a ROC satellite, supervises the Clinical Sites, as well as the laboratory and systems biology components. Barbara Tilley of The UTHealth School of Public Health is the PI of the Data Coordinating Center, a ROC satellite, manages the data, oversees data quality, provides analyses of blinded and unblinded data, provides on-site study monitors, and reports on safety and interim analyses to the Data Safety Monitoring Committee. RELEVANCE: The knowledge gained from this Phase III trial will impact the way in which massively bleeding patients at hospitals are transfused. By making better decisions regarding which patients are most in need of a massive transfusion, and transfusing the right ratio of blood products to mitigate potential traumatic coagulopathies, trauma teams will be afforded an ability to impact populations and lower the amount of otherwise preventable deaths resulting from hemorrhagic shock.

描述（由申请人提供）：复苏结局联盟（ROC）将进行前瞻性、随机、最佳血小板和血浆比率（PROPPR）III期试验，以比较580例接受不同血液制品比率的受试者的24小时和30天死亡率（共同主要结局）。PROPPR中的受试者必须符合合格标准，并且预计在紧急入住I级成人创伤中心后24小时内接受大量输血（MT）。该试验从至少四个研究中心进行的Vanguard阶段（120名受试者）开始，研究两种比例（1：1：2，1：1：3，血浆：血小板：RBC），并选择更好的组进行III期试验，与1：1：1进行比较。最接近于全血。每组40名受试者，提供83%的正确选择更好的手臂的概率。在先锋阶段，我们将评估方案的安全性，可行性，并开始研究创伤诱导的凝血功能障碍（TIC）和炎症标志物。 在III期，共580例受试者（包括来自Vanguard阶段的80例），提供90%的把握度检测24小时死亡率差异为10%或以上，提供88%的把握度检测30天死亡率差异为12%或以上，假设每个α =0.044，双侧检验，1：1：1组。将使用Mantel-Haenszel检验，研究中心作为分层变量。我们将描述TIC和炎症的机械驱动因素和后遗症，并描述随机患者严重损伤后复苏时凝血环境的自然史。考虑到危及生命的情况和每个治疗组的获益前景，将使用知情同意例外。 ROC数据协调中心（DCC）的Susanne May是主要研究者（PI）。Gerald货车贝儿，DCC，是PI-PROPPR。John Holcomb是UTHealth临床协调中心（ROC卫星）的PI，负责监督临床研究中心以及实验室和系统生物学部分。 UTHealth公共卫生学院的Barbara蒂利（Tilley）是数据协调中心（ROC卫星）的PI，负责管理数据、监督数据质量、提供盲态和非盲态数据分析、提供现场研究监测员，并向数据安全监测委员会报告安全性和中期分析。 相关性：从这项III期试验中获得的知识将影响医院大出血患者的输血方式。通过更好地决定哪些患者最需要大量输血，并使用正确的血液制品比例来减轻潜在的创伤性凝血功能障碍，创伤团队将能够影响人群并降低失血性休克导致的其他可预防死亡的数量。