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

NCT04387305 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2025-12-15

No results posted yet for this study

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.

Conditions

  • Brain Injuries, Traumatic
  • Wounds and Injury
  • Hemorrhage
  • Trauma Injury

Interventions

DRUG

Tranexamic acid injection

Active drug is provided to participants as described based on the TXA arm they are randomized to.

Sponsors & Collaborators

  • Pediatric Emergency Care Applied Research Network

    collaborator NETWORK

  • Daniel Nishijima, MD, MAS

    lead OTHER

Principal Investigators

  • Daniel K Nishijima, MD, MAS · University of California, Davis

  • Nathan Kuppermann, MD, MPH · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2031-03-31
Completion
2031-03-31
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04387305 on ClinicalTrials.gov