MedTrace Logo

Tranexamic Acid Mechanisms and Pharmacokinetics in Traumatic Injury

NCT02535949 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-08-31

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the effects of TXA on the immune system, its pharmacokinetics, as well as safety and efficacy in severely injured trauma patients.

Conditions

Interventions

DRUG

Tranexamic Acid

Tranexamic acid is a man-made form of an amino acid (protein) called lysine. Tranexamic acid prevents enzymes in the body from breaking down blood clots.

OTHER

Placebo

Matching Volume Normal Saline Placebo given IV over 10 minutes within 2 hours of initial injury

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Philip C Spinella, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-07-04
Completion
2017-07-07

Countries

  • United States

Study Locations

More Related Trials

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 NCT02535949 on ClinicalTrials.gov