Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): Study protocol for a pilot randomized controlled trial

Daniel K. Nishijima, John Vanburen, Hilary A. Hewes, Sage R. Myers, Rachel M. Stanley, P. David Adelson, Sarah E. Barnhard, Matthew Bobinski, Simona Ghetti, James F. Holmes, Ian Roberts, Walton O. Schalick, Nam K. Tran, Leah S. Tzimenatos, J. Michael Dean, Nathan Kuppermann, Marike Zwienenberg, Joseph Galante, Joseph Stephenson, Alfred F. TrappeyJordan Sandhu, T. Charles Casper, Stephen Fenton, Doug Brockmeyer, Theodore Pysher, Michael L. Nance, Shih Shan Lang Chen, Deborah Sesok-Pizzini, Raj Thakkar, Eric Sribnik, Kathleen Nichol

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

Abstract

Background: 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. Methods: 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). Discussion: 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. Trial registration: ClinicalTrials.gov registration number: NCT02840097. Registered on 14 July 2016.

Original languageEnglish (US)
Article number593
JournalTrials
Volume19
Issue number1
DOIs
StatePublished - Oct 30 2018

Keywords

  • Children
  • Tranexamic acid
  • Trauma

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

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