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RecruitingNCT06289478TXAUpdated Aug 5, 2026

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

An interventional study of Retrograde Intraarticular Injection via Drain Tube and Topical Soaking of Tranexamic Acid in Femoral Neck Fracture, sponsored by King Chulalongkorn Memorial Hospital. Recruiting at 2 sites in Thailand. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by King Chulalongkorn Memorial Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Femoral Neck Fracture

Keywords

  • tranexamic acid
  • femoral neck fracture
  • bipolar hemiarthroplasty
  • topical
  • blood transfusion
03

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
75 participants (estimated)

Study arms

  • 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

  • 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

  • Placebo comparator
    Standard procedure (placebo)

    Standard wound irrigation

    Drug: Placebo Comparator: Standard procedure (placebo)

Interventions

  • DrugRetrograde Intraarticular Injection via Drain Tube

    Tranexamic acid will be injected via drain tube after wound closure

  • DrugTopical Soaking of Tranexamic Acid

    Tranexamic acid will be topically administered by soaking method

  • DrugPlacebo Comparator: Standard procedure (placebo)

    Standard wound management

05

What researchers measure

Primary outcomes

  1. Rate of blood transfusion

    Proportion of patients received blood transfusion divided by total number of patient in a group

    Time frame: 2 years, or until complete enrollment

Secondary outcomes

  1. Volume of blood transfusion

    total volume of blood transfusion per each patient

    Time frame: 2 years, or until complete enrollment

  2. Calculated blood loss

    Calculating using Nadler and Goss formula

    Time frame: 2 years, or until complete enrollment

  3. Any adverse events

    Adverse events include wound complication, deep vein thrombosis, pulmonary embolism, and other complication

    Time frame: 2 years, or until complete enrollment

  4. In-hospital mortality

    In-hospital mortality

    Time frame: During admission period

06

Study locations

1 of 2 sites recruiting
  • Faculty of Medicine, King Chulalongkorn Memorial Hospital
    Bangkok, Bangkok 10330, Thailand
    Recruiting
  • Faculty of Medicine
    Bangkok, Bangkok 10330, Thailand
    • Kanyakorn - Riewruja · Contact · kanyakorn.riew@gmail.com · +66-95-864-4447
    • Kanyakorn Riewruja, MD · Principal investigator
    Not yet recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06289478
Lead sponsor
King Chulalongkorn Memorial Hospital
Responsible party
Kanyakorn Riewruja (Doctor, King Chulalongkorn Memorial Hospital) — Principal investigator
First posted
Mar 4, 2024
Start date
Jul 3, 2024
Primary completion
Aug 31, 2026 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Aug 5, 2026

Study contacts

Riewruja, Medical degree
Contact
kanyakorn.riew@gmail.com
+66958644447
Tantavisut, MD., PhD.
Contact
super_petch@yahoo.com
Kanyakorn Riewruja, Medical degree
principal investigator · Chulalongkorn University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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