Not Yet RecruitingPhase 3

Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children: An Efficacy Study

2,000 participantsStarted 2026-10-01

Plain-language summary

Trauma is the leading cause of death and disability in children in the United States. The objective of this study is to evaluate the benefits and harms of tranexamic acid (TXA; a drug that stops bleeding) in severely injured children with hemorrhagic brain and/or torso injuries. Using thromboelastography, we will measure baseline fibrinolysis to assess for treatment effects of TXA at different levels of fibrinolysis.

Who can participate

Age range0 Years – 17 Years

SexALL

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Inclusion criteria

✓. Less than 18 years old AND
✓. Penetrating torso trauma, blunt torso trauma, or head trauma as defined below:
✓. Penetrating Torso Trauma:
✓. Blunt Torso Trauma:
✓. Clinician suspicion of hemorrhagic blunt torso injury and at least one of the following:
✓. Hemothorax on chest tube placement or imaging,
✓. Clinical suspicion of hemorrhagic blunt torso injury and Intraperitoneal fluid on abdominal ultrasonography (Focused Assessment with Sonography in Trauma),
✓. Intra-abdominal injury on CT with either contrast extravasation or more than trace intraperitoneal fluid,

What they're measuring

Pediatric Quality of Life Inventory (PedsQL) area under the curve

Timeframe: 1 week, 1 month, 3 months, and 6 months (as measured as an area under the curve)

Trial details

NCT IDNCT04387305

SponsorDaniel Nishijima, MD, MAS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-03-31

Contact for this trial

Daniel K Nishijima, MD, MAS

916.734.3884 dnishijima@ucdavis.edu

View on ClinicalTrials.gov More Brain Injuries, Traumatic trials