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Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children: A Pilot and Feasibility Study

NCT02840097 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-09-05

Study results available
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Summary

Trauma is the leading cause of death and disability in children in the United States. The long-term goal of this project is to evaluate the benefits and harms of tranexamic acid (TXA; a drug that stops bleeding) in severely injured children. This is a 40-patient pilot study to evaluate the feasibility of two subsequent large-scale studies of TXA in injured children.

Conditions

Interventions

DRUG

Tranexamic Acid

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

DRUG

Placebo

Normal saline is provided to participants if randomized to this treatment arm.

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-04
Primary Completion
2020-10-03
Completion
2020-10-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT02840097 on ClinicalTrials.gov