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Prospective Study: TXA, Anticoagulant, Orthopaedic Trauma

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07116395
Acronym
TXA
Enrollment
200
Registered
2025-08-11
Start date
2027-01-01
Completion date
2030-12-31
Last updated
2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

TXA, Anticoagulant, Orthopaedic Trauma

Brief 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.

Interventions

DRUGTranexamic Acid (TXA)

orthopedic trauma patients who are on anticoagulation

Sponsors

Arbi Nazarian, MD
Lead SponsorOTHER
Inspire Health Medical Group
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

*

Design outcomes

Primary

MeasureTime frameDescription
Estimated blood loss (EBL) comparison between those who received TXA vs no TXAEBL note is made post-procedure by surgical team, and research team will collect data at least one month post-procedureLess estimated blood loss after surgery for patients who were administered TXA

Secondary

MeasureTime frameDescription
Hospital Length of Stay for Patients who received TXA vs no TXAEBL note is made post-procedure by surgical team, and research team will collect data at least one month post-procedurePatient medical records will be reviewed post-operatively and data will be collected in our study specific data sheet.

Countries

United States

Contacts

CONTACTYeng Vue, MA
Yeng.Vue@ucsf.edu559-761-5636
CONTACTMolly Mounsey, MD
Molly.Mounsey@ucsf.edu206-499-7945
PRINCIPAL_INVESTIGATORArbi Nazarian, MD

University of California, San Francisco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026