Prospective Study: TXA, Anticoagulant, Orthopaedic Trauma

NCT ID: NCT07116395

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2030-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Yes TXA Administered

Group Type: EXPERIMENTAL

Tranexamic Acid (TXA)

Intervention Type: DRUG

orthopedic trauma patients who are on anticoagulation

No TXA Administered

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tranexamic Acid (TXA)

orthopedic trauma patients who are on anticoagulation

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inspire Health Medical Group

UNKNOWN

Sponsor Role: collaborator

Arbi Nazarian, MD

OTHER

Sponsor Role: lead

Responsible Party

Arbi Nazarian, MD

Assistant Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Arbi Nazarian, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Community Regional Medical Center

Fresno, California, United States

Countries

United States

Central Contacts

Yeng Vue, MA

Role: CONTACT

Yeng.Vue@ucsf.edu

559-761-5636

Molly Mounsey, MD

Role: CONTACT

Molly.Mounsey@ucsf.edu

206-499-7945

Facility Contacts

Yeng Vue, MA

Role: primary

Yeng.Vue@ucsf.edu

559-761-5636

References

Lin YK, Liu KT, Chen CW, Lee WC, Lin CJ, Shi L, Tien YC. How to effectively obtain informed consent in trauma patients: a systematic review. BMC Med Ethics. 2019 Jan 23;20(1):8. doi: 10.1186/s12910-019-0347-0.

Reference Type: BACKGROUND

PMID: 30674301 (View on PubMed)

Ockerman A, Vanassche T, Garip M, Vandenbriele C, Engelen MM, Martens J, Politis C, Jacobs R, Verhamme P. Tranexamic acid for the prevention and treatment of bleeding in surgery, trauma and bleeding disorders: a narrative review. Thromb J. 2021 Aug 11;19(1):54. doi: 10.1186/s12959-021-00303-9.

Reference Type: BACKGROUND

PMID: 34380507 (View on PubMed)

Zhang P, Liang Y, Chen P, Fang Y, He J, Wang J. Combined application versus topical and intravenous application of tranexamic acid following primary total hip arthroplasty: a meta-analysis. BMC Musculoskelet Disord. 2017 Feb 21;18(1):90. doi: 10.1186/s12891-017-1429-0.

Reference Type: BACKGROUND

PMID: 28222709 (View on PubMed)

Zhu Q, Yu C, Chen X, Xu X, Chen Y, Liu C, Lin P. Efficacy and Safety of Tranexamic Acid for Blood Salvage in Intertrochanteric Fracture Surgery: A Meta-Analysis. Clin Appl Thromb Hemost. 2018 Nov;24(8):1189-1198. doi: 10.1177/1076029618783258. Epub 2018 Jun 21.

Reference Type: BACKGROUND

PMID: 29929380 (View on PubMed)

Deng ZF, Zhang ZJ, Sheng PY, Fu M, Xu DL, He AS, Liao WM, Kang Y. Effect of 3 different anticoagulants on hidden blood loss during total hip arthroplasty after tranexamic acid. Medicine (Baltimore). 2020 Sep 4;99(36):e22028. doi: 10.1097/MD.0000000000022028.

Reference Type: BACKGROUND

PMID: 32899057 (View on PubMed)

Hourlier H, Fennema P. Tranexamic acid use and risk of thrombosis in regular users ofantithrombotics undergoing primary total knee arthroplasty: a prospectivecohort study. Blood Transfus. 2018 Jan;16(1):44-52. doi: 10.2450/2016.0160-16. Epub 2016 Oct 4.

Reference Type: BACKGROUND

PMID: 27723454 (View on PubMed)

Hunt BJ. The current place of tranexamic acid in the management of bleeding. Anaesthesia. 2015 Jan;70 Suppl 1:50-3, e18. doi: 10.1111/anae.12910.

Reference Type: BACKGROUND

PMID: 25440395 (View on PubMed)

Other Identifiers

Nazarian_TXA_Prospective2025

Identifier Type: -

Identifier Source: org_study_id