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.
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Details
1 UC Davis School of Medicine, Department of Emergency Medicine, Sacramento, USA (GRID:grid.27860.3b) (ISNI:0000 0004 1936 9684)
2 University of Utah School of Medicine, Department of Pediatrics, Salt Lake City, USA (GRID:grid.223827.e) (ISNI:0000 0001 2193 0096)
3 University of Utah School of Medicine, Primary Children’s Hospital, Department of Pediatrics, Division of Pediatric Emergency Medicine, Salt Lake City, USA (GRID:grid.223827.e) (ISNI:0000 0001 2193 0096)
4 Perelman School of Medicine at the University of Pennsylvania, Children’s Hospital of Philadelphia, Department of Pediatrics, Division of Pediatric Emergency Medicine, Philadelphia, USA (GRID:grid.223827.e)
5 Ohio State University School of Medicine, Nationwide Children’s Hospital, Department of Pediatrics, Division of Pediatric Emergency Medicine, Columbus, USA (GRID:grid.240344.5) (ISNI:0000 0004 0392 3476)
6 Barrow Neurological Institute at Phoenix Children’s Hospital, Department of Pediatric Neurosciences, Phoenix, USA (GRID:grid.427785.b) (ISNI:0000 0001 0664 3531)
7 UC Davis School of Medicine, Department of Pathology and Laboratory Medicine, Sacramento, USA (GRID:grid.27860.3b) (ISNI:0000 0004 1936 9684)
8 UC Davis School of Medicine, Department of Radiology, Sacramento, USA (GRID:grid.27860.3b) (ISNI:0000 0004 1936 9684)
9 University of California, Davis, Department of Psychology, Davis, USA (GRID:grid.27860.3b) (ISNI:0000 0004 1936 9684)
10 London School of Hygiene and Tropical Medicine, Department of Population Health, London, UK (GRID:grid.8991.9) (ISNI:0000 0004 0425 469X)
11 University of Wisconsin, Department of Orthopedics and Rehabilitation, Madison, USA (GRID:grid.28803.31) (ISNI:0000 0001 0701 8607)
12 University of California, Davis, Department of Pathology and Laboratory Medicine, Davis, USA (GRID:grid.27860.3b) (ISNI:0000 0004 1936 9684)
13 UC Davis School of Medicine, Departments of Emergency Medicine and Pediatrics, Sacramento, USA (GRID:grid.27860.3b) (ISNI:0000 0004 1936 9684)