ArticleAcademic emergency medicine : official journal of the Society for Academic Emergency Medicine2022
Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): A pilot randomized trial.
Article in Academic emergency medicine : official journal of the Society for Academic Emergency Medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
5 citing papers in PubMed, 15 citations in OpenAlex.
- Efficacy and Safety of Tranexamic Acid in Pediatric Trauma: A Systematic Review and Meta-Analysis.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2026Article
- Tranexamic Acid in Pediatric Care: A Comprehensive Overview.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2026Article
- Evidence-Informed Quality Indicators for Pediatric Trauma Care.JAMA pediatrics · 2025Article
- Highlights From the 2023 Revision of Pediatric Tactical Emergency Casualty Care Guidelines.Pediatric emergency care · 2025Article
- Perioperative considerations in the paediatric patient with congenital and acquired coagulopathy.BJA open · 2024Review
Corrections and comments
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Authors and funding
16 authors at 9 institutions in 2 countries.
Funding
Abstract
backgroundThe antifibrinolytic drug tranexamic acid (TXA) improves survival in adults with traumatic hemorrhage; however, the drug has not been evaluated in a trial in injured children. We assessed the feasibility of a large-scale trial evaluating the effects of TXA in children with severe hemorrhagic injuries.
methodsSeverely injured children (0 up to 18th birthday) were randomized into a double-blind randomized trial of (1) TXA 15 mg/kg bolus dose, followed by 2 mg/kg/h infusion over 8 h, (2) TXA 30 mg/kg bolus dose, followed by 4 mg/kg/h infusion over 8 h, or (3) normal saline placebo bolus and infusion. The trial was conducted at four pediatric Level I trauma centers in the United States between June 2018 and March 2020. We enrolled patients under federal exception from informed consent (EFIC) procedures when parents were unable to provide informed consent. Feasibility outcomes included the rate of enrollment, adherence to intervention arms, and ability to measure the primary clinical outcome. Clinical outcomes included global functioning (primary), working memory, total amount of blood products transfused, intracranial hemorrhage progression, and adverse events. The target enrollment rate was at least 1.25 patients per site per month.
resultsA total of 31 patients were randomized with a mean age of 10.7 years (standard deviation [SD] 5.0 years) and 22 (71%) patients were male. The mean time from injury to randomization was 2.4 h (SD 0.6 h). Sixteen (52%) patients had isolated brain injuries and 15 (48%) patients had isolated torso injuries. The enrollment rate using EFIC was 1.34 patients per site per month. All eligible enrolled patients received study intervention (nine patients TXA 15 mg/kg bolus dose, 10 patients TXA 30 mg/kg bolus dose, and 12 patients placebo) and had the primary outcome measured. No statistically significant differences in any of the clinical outcomes were identified.
conclusionBased on enrollment rate, protocol adherence, and measurement of the primary outcome in this pilot trial, we confirmed the feasibility of conducting a large-scale, randomized trial evaluating the efficacy of TXA in severely injured children with hemorrhagic brain and/or torso injuries using EFIC.
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