Abstract
BackgroundTrauma 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.MethodsChildren 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).DiscussionThis 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.Trial registrationClinicalTrials.gov registration number: NCT02840097. Registered on 14 July 2016.
Highlights
Trauma is the leading cause of morbidity and mortality in children in the United States
We previously demonstrated that tranexamic acid (TXA) is rarely given for injured children in US children’s hospitals [16]
The primary objective of this pilot trial is to assess the overall feasibility for a subsequent, confirmatory clinical trial evaluating the efficacy of TXA in children with severe hemorrhagic injuries
Summary
Study design This pilot study is a double-blind, randomized, controlled trial of children younger than 18 years with hemorrhagic injuries to the torso and brain. Children will be randomized into 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), and (3) normal saline placebo This pilot study will be conducted in preparation for a confirmatory clinical trial of TXA administration for children with hemorrhagic torso and/or brain injuries (Fig. 1). Interventions Enrolled patients will be randomized to one of three study arms: TXA dose A, TXA dose B, or placebo. We estimate that there will be 1.25 eligible patients per site per month This eligibility rate would justify the feasibility of conducting a subsequent confirmatory clinical trial evaluating the safety and efficacy of TXA in severely injured children. Our trial protocol was revised to include EFIC procedures if parents or guardians are not available or able to provide written informed consent
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