Related Experiment Video
Updated: Sep 30, 2025
Systems Analysis of the Neuroinflammatory and Hemodynamic Response to Traumatic Brain Injury
Published on: May 27, 2022
Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): A pilot randomized trial
Daniel K Nishijima1, John M VanBuren2, Seth W Linakis3
1Department of Emergency Medicine, UC Davis School of Medicine, Sacramento, California, USA.
Insights
This study found that a large-scale trial of tranexamic acid (TXA) in children with severe traumatic hemorrhage is feasible. Enrollment rates and protocol adherence were successful, supporting future efficacy studies of TXA for pediatric trauma.
Area of Science:
- Pediatric Trauma Care
- Hemorrhagic Injury Management
- Clinical Trial Feasibility
Background:
- Tranexamic acid (TXA), an antifibrinolytic, improves survival in adult trauma patients.
- Limited data exists on TXA efficacy in pediatric severe hemorrhagic injuries.
- This study assessed the feasibility of a large-scale TXA trial in children.
Purpose of the Study:
- To evaluate the feasibility of conducting a randomized trial on TXA for severely injured children.
- To determine enrollment rates, adherence, and outcome measurement capabilities.
- To inform the design of future TXA efficacy studies in pediatric trauma.
Main Methods:
- A double-blind, randomized trial involving severely injured children (0-18 years).
- Three arms: TXA 15 mg/kg bolus + infusion, TXA 30 mg/kg bolus + infusion, or placebo.
- Utilized federal exception from informed consent (EFIC) for enrollment.
- Feasibility assessed by enrollment rate (target 1.25/site/month), adherence, and primary outcome measurement.
Main Results:
- 31 children were randomized across four Level I pediatric trauma centers.
- Enrollment rate achieved was 1.34 patients/site/month using EFIC.
- All enrolled patients received their assigned intervention and had the primary outcome measured.
- No statistically significant differences were found in clinical outcomes between groups.
Conclusions:
- The pilot trial demonstrated feasibility for a large-scale TXA trial in severely injured children.
- Successful enrollment, adherence, and outcome measurement support future efficacy research.
- TXA may be a viable treatment for hemorrhagic injuries in pediatric trauma patients.
Background:
The 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.
Methods:
Severely 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.
Results:
A 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.
Conclusion:
Based 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.
Related Concept Videos
01:30Acute Kidney Injury IV: Diagnostic Studies and Prevention
01:16Clinical Trials
There are four phases in a clinical trial. A phase one...