Prospective Study: TXA, Anticoagulant, Orthopaedic Trauma

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tranexamic Acid (TXA) — DRUG
  orthopedic trauma patients who are on anticoagulation

Study Details

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.

Key Dates

Start date

Jan 1, 2026

Status verified

Aug 2025

Primary completion

Jun 30, 2029

Completion

Dec 31, 2030

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Yes TXA Administered
• No Intervention: No TXA Administered

Primary Outcome Measure

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 ]

Central Contacts

• Yeng Vue, MA
  559-761-5636
  [email protected]
• Molly Mounsey, MD
  206-499-7945
  [email protected]

Locations (1)

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