Nishijima Daniel K, VanBuren John, Hewes Hilary A, Myers Sage R, Stanley Rachel M, Adelson P David, Barnhard Sarah E, Bobinski Matthew, Ghetti Simona, Holmes James F, Roberts Ian, Schalick Walton O, Tran Nam K, Tzimenatos Leah S, Michael Dean J, Kuppermann Nathan
Department of Emergency Medicine, UC Davis School of Medicine, 4150 V. Street, PSSB 2100, Sacramento, CA, 95817, USA.
Department of Pediatrics, University of Utah School of Medicine, 295 Chipeta Way, Salt Lake City, UT, 84108, USA.
Trials. 2018 Oct 30;19(1):593. doi: 10.1186/s13063-018-2974-z.
Trauma is the leading cause of morbidity and mortality in children in the United States. The antifibrinolytic drug tranexamic acid (TXA) improves survival in adults with traumatic hemorrhage, however, the drug has not been evaluated in a clinical trial in severely injured children. We designed the Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children (TIC-TOC) trial to evaluate the feasibility of conducting a confirmatory clinical trial that evaluates the effects of TXA in children with severe trauma and hemorrhagic injuries.
Children with severe trauma and evidence of hemorrhagic torso or brain injuries will be randomized to one of three arms: (1) TXA dose A (15 mg/kg bolus dose over 20 min, followed by 2 mg/kg/hr infusion over 8 h), (2) TXA dose B (30 mg/kg bolus dose over 20 min, followed by 4 mg/kg/hr infusion over 8 h), or (3) placebo. We will use permuted-block randomization by injury type: hemorrhagic brain injury, hemorrhagic torso injury, and combined hemorrhagic brain and torso injury. The trial will be conducted at four pediatric Level I trauma centers. We will collect the following outcome measures: global functioning as measured by the Pediatric Quality of Life (PedsQL) and Pediatric Glasgow Outcome Scale Extended (GOS-E Peds), working memory (digit span test), total amount of blood products transfused in the initial 48 h, intracranial hemorrhage progression at 24 h, coagulation biomarkers, and adverse events (specifically thromboembolic events and seizures).
This multicenter trial will provide important preliminary data and assess the feasibility of conducting a confirmatory clinical trial that evaluates the benefits of TXA in children with severe trauma and hemorrhagic injuries to the torso and/or brain.
ClinicalTrials.gov registration number: NCT02840097 . Registered on 14 July 2016.
创伤是美国儿童发病和死亡的主要原因。抗纤维蛋白溶解药物氨甲环酸（TXA）可提高创伤性出血成人的生存率，然而，该药物尚未在严重受伤儿童的临床试验中进行评估。我们设计了儿童创伤性损伤氨甲环酸评估临床试验（TIC-TOC），以评估开展一项验证性临床试验的可行性，该试验旨在评估TXA对严重创伤和出血性损伤儿童的影响。
患有严重创伤且有躯干或脑部出血性损伤证据的儿童将被随机分为三组之一：（1）TXA剂量A（20分钟内静脉推注15mg/kg，随后8小时内以2mg/kg/小时的速度输注），（2）TXA剂量B（20分钟内静脉推注30mg/kg，随后8小时内以4mg/kg/小时的速度输注），或（3）安慰剂。我们将按损伤类型采用置换区组随机化：出血性脑损伤、出血性躯干损伤以及出血性脑和躯干联合损伤。该试验将在四个一级儿科创伤中心进行。我们将收集以下结果指标：通过儿童生活质量量表（PedsQL）和儿童扩展格拉斯哥预后量表（GOS-E Peds）测量的整体功能、工作记忆（数字广度测试）、最初48小时内输注的血液制品总量、24小时时颅内出血进展情况、凝血生物标志物以及不良事件（特别是血栓栓塞事件和癫痫发作）。
这项多中心试验将提供重要的初步数据，并评估开展一项验证性临床试验的可行性，该试验旨在评估TXA对严重创伤以及躯干和/或脑部出血性损伤儿童的益处。
ClinicalTrials.gov注册号：NCT02840097。于2016年7月14日注册。
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