MASSIVE TRANSFUSION EPIDEMIOLOGY AND OUTCOMES IN CHILDREN (MATIC) STUDY

儿童大规模输血流行病学和结果 (MATIC) 研究

• 批准号: 9182482
• 负责人: CASSANDRA D JOSEPHSON
• 金额: $ 19.78万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-01 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9182482
• 关键词: Accounting; Acidosis; Activation Analysis; Adult; Affect; Age; American College of Surgeons; Blood Banks; Blood Coagulation Disorders; Blood Platelets; Categories; Cause of Death; Cessation of life; Characteristics; Child; Childhood; Coin; Data; Data Collection; Databases; Disseminated Intravascular Coagulation; Electronics; Epidemiology; Equilibrium; Erythrocytes; Etiology; Feasibility Studies; Frequencies; Fresh Frozen Plasmas; Funding; Gastrointestinal Hemorrhage; Gender; Goals; Hemodilution; Hemorrhage; Hemorrhagic Shock; Hemostatic Agents; Heterogeneity; Hospitals; Hypotension; Knowledge; Life; Literature; Medical; Medical center; Methods; Military Personnel; Modeling; Morbidity - disease rate; Multicenter Studies; Multicenter Trials; Observational Study; Online Systems; Operative Surgical Procedures; Outcome; Patient Care; Patients; Pediatric Hospitals; Plasma; Platelet Count measurement; Population; Postoperative Period; Preparation; Protocols documentation; Publishing; Resuscitation; Sampling; Shock; Site; Statistical Data Interpretation; Testing; Time; Tranexamic Acid; Transfusion; Trauma; Trauma patient; Traumatic injury; Variant; abstracting; base; blood product; clinical practice; comparative effectiveness; effectiveness research; high risk; hospital bed; improved; improved outcome; injured; innovation; mortality; natural hypothermia; pediatric patients; prospective; study population; tertiary care; therapy outcome; trauma centers

Abstract/Project Summary Life-threatening bleeding occurs from many etiologies in children, such as intra and post-operative bleeding, gastrointestinal bleeding, disseminated intravascular coagulation, and traumatic injury. The epidemiology, therapies commonly used, and outcomes related to severe hemorrhage has not been systematically studied in children, and is a major gap in our knowledge in this high-risk population. Damage Control Resuscitation (DCR) principles have been developed to reduce death from hemorrhage in adult trauma patients. One important concept within DCR is called hemostatic resuscitation, which has been defined as a high ratio of plasma and platelets to RBCs (> 1:2 units), as well as a small plasma deficit (RBC total units - plasma total units), both starting very early in the resuscitation. To implement hemostatic resuscitation, Massive Transfusion protocols (MTP) have been developed in many adult and pediatric tertiary care centers. Despite a paucity of evidence supporting hemostatic resuscitation in children, it is being generalized to pediatric practice for both traumatic and non-traumatic etiologies. The MAssive Transfusion epidemiology and outcomes In Children (MATIC) study is a multicenter, prospective, observational study that will collect data on all MTP activations on children at participating centers. The goal of this study is to determine the epidemiology, therapies used, and outcomes for children requiring MTP activation from all etiologies. We will prospectively collect data on all MTP activations in a consecutive sample of approximately 502 patients from 35 academic pediatric tertiary care centers into a web-based database over a 22-month period. We will determine if patient specific factors and inter-hospital variability are associated with MTP practice and outcomes. Our primary hypothesis is that morbidity and mortality outcomes will vary by patient illness category (operative vs traumatic vs medical). We also aim to determine if early and sustained hemostatic resuscitation is associated with increased survival in children with traumatic injury requiring MTP activation. We have collected preliminary data indicating the feasibility of the study and validity of the data collection methods. We have also limited the analysis of hemostatic resuscitation on outcomes to children with traumatic injury to reduce heterogeneity in the study population. This study is innovative due to the absence of pediatric multicenter data published on the epidemiology, therapies, and outcomes for children in this population. Our statistical analysis is also innovative. We will develop a sophisticated model that will incorporate propensity scores with the timing, ratio, and deficits of plasma and platelets to RBCs to determine if “hemostatic resuscitation” is associated with improved outcomes. Completion of this study will provide preliminary data that will provide support for large comparative effectiveness studies to determine which DCR principles affect outcomes in children with or without traumatic injury with severe life-threatening bleeding. High quality trials are essential to improve clinical practice since the mortality in this population ranges from 35 to 78%.

摘要/项目摘要 威胁生命的出血来自儿童的许多病因，例如内部和术后出血， 胃肠道出血，散布的血管内凝结和创伤性损伤。流行病学， 常用的疗法和与严重出血有关的结果尚未系统地研究 儿童，这是我们在这个高风险人群中所知的主要差距。损害控制复苏 （DCR）已经制定了成人创伤患者出血死亡的原则。一 DCR中的重要概念称为止血复苏，已被定义为高比例 等离子体和血小板为RBC（> 1：2单位），以及小血浆防御（RBC总单位 - 等离子体总计 单位），两者都在复苏的早期开始。为了实施止血复苏，大量输血 在许多成人和小儿三级护理中心已经开发了方案（MTP）。尽管很少 支持儿童止血复苏的证据，它被普遍为小儿实践 创伤性和非创伤性病因。儿童的大量输血流行病学和结果 （Matic）研究是一项多中心，前瞻性，观察性研究，将收集有关所有MTP激活的数据 参与中心的孩子。这项研究的目的是确定流行病学，所使用的疗法和 需要从所有病因激活MTP的儿童的结果。我们可能会收集所有MTP的数据 连续样本中的大约502名来自35个学术儿科三级护理的患者的激活 在22个月的时间内置于基于Web的数据库中。我们将确定患者的特定因素和 院间差异与MTP实践和结果有关。我们的主要假设是 发病率和死亡率结果将因患者疾病类别而异（手术与创伤与医疗）。我们 还旨在确定早期和持续的止血复苏是否与增加的生存率有关 需要MTP激活的创伤性损伤的儿童。我们已经收集了指示的初步数据 研究方法的可行性和有效性。我们还限制了对 对创伤性损伤儿童的结局止血性复苏以减少研究中的异质性 人口。由于缺乏关于有关的儿科多中心数据，这项研究具有创新性 该人群中儿童的流行病学，疗法和结果。我们的统计分析也是创新的。 我们将开发一个复杂的模型，将倾向分数与时机，比率定义和定义 血浆和血小板到RBC，以确定“止血复苏”是否与改善有关 结果。这项研究的完成将提供初步数据，为大型比较提供支持 有效性研究以确定哪些DCR原理会影响患有或没有创伤的儿童的结果 严重威胁生命的出血，受伤。高质量试验对于改善临床实践至关重要，因为 该人口的死亡率范围为35％至78％。