Traumatic Injury Clinical Trial Evaluating Tranexamic Acid In Children: A Pilot And Feasibility Randomized Controlled Trial
Daniel Nishijima1, John VanBuren2, Hilary Hewes3, Sage R Myers4, Rachel M Stanley5, Nam Tran1, Sarah Barnhard1, Simona Ghetti1, Matthew Bobinski1, P. David Adelson6, Ian Roberts7, James Holmes1, Leah Tzimenatos1, Walton Shalick, III8, *J. Michael Dean2, *Nathan Kuppermann, MD, MPH1
1UC Davis, Sacramento, CA;2University of Utah, Salt Lake City, UT;3Primary Children's Hospital, Salt Lake City, UT;4Children's Hospital of Philadelphia, Philadelphia, PA;5Nationwide Children's Hospital, Columbus, OH;6Barrow Neurological Institute at Phoenix Children's Hospital, Phoenix, AZ;7London School of Hygiene and Tropical Medicine, London, United Kingdom8University of Wisconsin, Madison, WI
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, TXA has not been evaluated in a clinical trial in 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 efficacy of TXA in children with severe trauma and hemorrhagic injuries.
Children with severe trauma and evidence of hemorrhagic torso and/or brain injuries were randomized to one of three arms: 1) TXA dose A (15 mg/kg bolus dose over 20 minutes, followed by 2 mg/kg/hr infusion over 8 hours), 2) TXA dose B (30 mg/kg bolus dose over 20 minutes, followed by 4 mg/kg/hr infusion over 8 hours), or 3) placebo bolus and infusion. We used permuted-block randomization by injury type: hemorrhagic brain injury, hemorrhagic torso injury, and combined hemorrhagic brain and torso injury. The trial was conducted at 4 pediatric Level I trauma centers. We collected 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 volume of blood products transfused in the initial 48 hours, intracranial hemorrhage progression at 24 hours, coagulation biomarkers, and adverse events (specifically thromboembolic events and seizures).
To be reported (trial ongoing but we will present the findings at the meeting)
Conclusions (implications for practice):
To be reported
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