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Prospective Study: TXA, Anticoagulant, Orthopaedic Trauma

NCT07116395 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-10-23

No results posted yet for this study

Summary

Tranexamic acid, an anti-fibrinolytic agent, is commonly given after induction of general anesthesia in patients undergoing hip and knee arthroplasty. This medication has been associated with decreased blood loss during these procedures, decreased rate of blood transfusion, decreased hospital costs, and no increased risk of thrombotic complication. Given the safety and efficacy of this medication in one subspeciality of orthopedics, it is warranted to investigate the use of it in another subspeciality where blood loss is also of concern. It is also of the utmost importance to identify medications that can safely be given to our population to not only improve patient outcomes but also decrease patient costs in the setting of significant disparities. The application of these findings to orthopedic trauma is not something that has been largely studied or appears in the literature. We hope to fill this gap of knowledge to allow for the application of a safe and beneficial medication to a much larger subset of patients than that that is already receiving the medication routinely. The use of TXA in orthopedic patients who are on anticoagulation versus those who are not is also not something that has been previously studied and another knowledge gap that we hope to fill.

Conditions

  • Patients Undergoing Operative Fixation of Long Bone Fractures Within the Community Medical Centers System

Interventions

DRUG

Tranexamic Acid (TXA)

orthopedic trauma patients who are on anticoagulation

Sponsors & Collaborators

  • Inspire Health Medical Group

    collaborator UNKNOWN

  • Arbi Nazarian, MD

    lead OTHER

Principal Investigators

  • Arbi Nazarian, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2029-06-30
Completion
2030-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT07116395 on ClinicalTrials.gov