Efficacy and Safety of Topical Tranexamic Acid (TXA) Administration Cementless Bipolar Hemiarthroplasty for Femoral Neck Fracture - a Randomized Controlled Trial (TXA)

August 3, 2026 updated by: Kanyakorn Riewruja, King Chulalongkorn Memorial Hospital

Efficacy and Safety of Retrograde Intraarticular Injection Via Drain Tube, Topical Soaking of Tranexamic Acid (TXA), or Placebo in Elderly Patients With Femoral Neck Fractures Undergoing Bipolar Hemiarthroplasty

The goal of this Randomized controlled trial is to evaluate in household ambulatory, elderly patients sustaining femoral neck fracture who are subjected to be treat with cementless bipolar hemiarthroplasty. The main questions it aims to answer are:

  • The efficacy in reducing blood transfusion for topical tranexamic acid administration
  • The safety of tranexemic acid, topically used

As having undergone bipolar hemiarthroplasty surgery, participants will either receive retrograde intraarticular tranexamic acid injection via drain tube, or topical soaking administration.

Researchers will compare, with standard procedure (procedure), whether topically administered tranexamic acid would reduce rate of blood transfusion.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Perioperative blood loss and transfusion are common in elderly patients undergoing bipolar hemiarthroplasty for femoral neck fractures, and are associated with anemia-related morbidity and transfusion-related risk. Although tranexamic acid (TXA) reduces blood loss and transfusion in elective arthroplasty, topical administration has been proposed to preserve local hemostatic efficacy while limiting systemic exposure in this comorbid population, but the optimal topical route in hip fracture surgery remains uncertain.

This study compared the efficacy and safety of topical soaking (TS) and intra-articular (IA) TXA with placebo in patients undergoing bipolar hemiarthroplasty.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
    • Bangkok
      • Bangkok, Bangkok, Thailand, 10330
        • Recruiting
        • Faculty of Medicine, King Chulalongkorn Memorial Hospital
        • Contact:
      • Bangkok, Bangkok, Thailand, 10330
        • Not yet recruiting
        • Faculty of Medicine
        • Principal Investigator:
          • Kanyakorn Riewruja, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Elderly patients (age > 60 years)
  • Femoral neck fractures from low energy mechanism
  • Household ambulator
  • Undergoing cementless bipolar hemiarthroplasty at KCMH
  • Informed consent

Exclusion Criteria:

  • Allergy to TXA
  • History of VTE
  • History of hip surgery, pathological fracture, hip infection
  • Congenital or acquired coagulopathy
  • Hb < 10 g/dL or Platelet < 140,000

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Retrograde Intraarticular Injection via Drain Tube
Tranexamic acid will be injected retrograde to the joint via drain tube after surgical wound closure
Drug: Retrograde Intraarticular Injection via Drain Tube
Tranexamic acid will be injected via drain tube after wound closure
Experimental: Topical Soaking of Tranexamic Acid
Tranexamic acid will be placed to soak the intramedullary canal of the femur and surgical area after sheath closure for 5 minutes and completely remove by sunction
Drug: Topical Soaking of Tranexamic Acid
Tranexamic acid will be topically administered by soaking method
Placebo Comparator: Standard procedure (placebo)
Standard wound irrigation
Drug: Placebo Comparator: Standard procedure (placebo)
Standard wound management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of blood transfusion
Time Frame: 2 years, or until complete enrollment
Proportion of patients received blood transfusion divided by total number of patient in a group
2 years, or until complete enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of blood transfusion
Time Frame: 2 years, or until complete enrollment
total volume of blood transfusion per each patient
2 years, or until complete enrollment
Calculated blood loss
Time Frame: 2 years, or until complete enrollment
Calculating using Nadler and Goss formula
2 years, or until complete enrollment
Any adverse events
Time Frame: 2 years, or until complete enrollment
Adverse events include wound complication, deep vein thrombosis, pulmonary embolism, and other complication
2 years, or until complete enrollment
In-hospital mortality
Time Frame: During admission period
In-hospital mortality
During admission period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Chulalongkorn Memorial Hospital

Investigators

  • Principal Investigator: Kanyakorn Riewruja, Medical degree, Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

February 25, 2024

First Submitted That Met QC Criteria

February 25, 2024

First Posted (Actual)

March 4, 2024

Study Record Updates

Last Update Posted (Actual)

August 5, 2026

Last Update Submitted That Met QC Criteria

August 3, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0151/67

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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