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OpenTrials
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NCT Number: NCT07116395

Prospective Study: TXA, Anticoagulant, Orthopaedic Trauma

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Community Regional Medical Center

Fresno, California, 93701, United States

Location contact

Arbi Nazarian, MD

PRINCIPAL_INVESTIGATOR

Molly Mounsey, MD

SUB_INVESTIGATOR

Yeng Vue, MA

CONTACT

[email protected]

559-761-5636

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing operative fixation of long bone fractures; Included conditions include femoral neck fractures, intertrochanteric femur fractures, femoral shaft fractures, distal femur fractures, and tibial shaft fractures that undergo surgical management

Exclusion criteria

  • Exclusion criteria for this study will be patients under 18 and prisoners

Treatment and study plan

Tranexamic acid (TXA)

Drug

orthopedic trauma patients who are on anticoagulation

Primary outcomes

  1. Estimated blood loss (EBL) comparison between those who received TXA vs no TXA

    Time frame: EBL note is made post-procedure by surgical team, and research team will collect data at least one month post-procedure

    Less estimated blood loss after surgery for patients who were administered TXA

Secondary outcomes

  1. Hospital Length of Stay for Patients who received TXA vs no TXA

    Time frame: EBL note is made post-procedure by surgical team, and research team will collect data at least one month post-procedure

    Patient medical records will be reviewed post-operatively and data will be collected in our study specific data sheet.

Study contacts

Contact information is provided by the study sponsor or research team.

Molly Mounsey, MD

CONTACT

[email protected]

206-499-7945

Yeng Vue, MA

CONTACT

[email protected]

559-761-5636

Sponsors and collaborators

Lead sponsor

Arbi Nazarian, MD

Other

Collaborators

  • Inspire Health Medical Group

Registry information

Official study title

Outcomes of Tranexamic Acid With Anticoagulants in Orthopaedic Trauma Procedures: A Prospective Study

Acronym: TXA

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Aug 11, 2025
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.