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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

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

Authors: 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 III, Nam K. Tran, Leah S. Tzimenatos, J. Michael Dean, Nathan Kuppermann, for the TIC-TOC Collaborators of the Pediatric Emergency Care Applied Research Network

Published in: Trials | Issue 1/2018

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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.
Appendix
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Metadata
Title
Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): study protocol for a pilot randomized controlled trial
Authors
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 III
Nam K. Tran
Leah S. Tzimenatos
J. Michael Dean
Nathan Kuppermann
for the TIC-TOC Collaborators of the Pediatric Emergency Care Applied Research Network
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2974-z

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