Prospective Study: TXA, Anticoagulant, Orthopaedic Trauma

NCT07116395 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: Nazarian_TXA_Prospective2025
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

TXA; Anticoagulant; Orthopaedic Trauma

Outcome Measures

Primary Outcomes (1)

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

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

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

Secondary Outcomes (1)

• Hospital Length of Stay for Patients who received TXA vs no TXA

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

Study Arms (2)

Yes TXA Administered

EXPERIMENTAL

Drug: Tranexamic Acid (TXA)

No TXA Administered

NO INTERVENTION

Interventions

Tranexamic Acid (TXA) DRUG

orthopedic trauma patients who are on anticoagulation

Yes TXA Administered

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Arbi Nazarian, MD: lead
• Inspire Health Medical Group: collaborator

Study Sites (1)

Community Regional Medical Center

Fresno, California, 93701, United States

Location

Related Publications (7)

• 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.

  PMID: 30674301 BACKGROUND

• 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.

  PMID: 34380507 BACKGROUND

• 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.

  PMID: 28222709 BACKGROUND

• 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.

  PMID: 29929380 BACKGROUND

• 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.

  PMID: 32899057 BACKGROUND

• 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.

  PMID: 27723454 BACKGROUND

• 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.

  PMID: 25440395 BACKGROUND

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Arbi Nazarian, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yeng Vue, MA

CONTACT

559-761-5636; Yeng.Vue@ucsf.edu

Molly Mounsey, MD

CONTACT

206-499-7945; Molly.Mounsey@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 11, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 23, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)