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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

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 4 months later.
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

In context

Femoral Neck Fractures

207 studies on the registry are indexed under Femoral Neck Fractures; 40 are open to participants now.

This study's planned enrollment of 75 is below the median of 100 across 142 interventional studies indexed under Femoral Neck Fractures.

Browse Femoral Neck Fractures studies →

Lead sponsor

King Chulalongkorn Memorial Hospital is the lead sponsor of 43 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Allergy to TXA
  • History of VTE
  • History of hip surgery, pathological fracture, hip infection
  • Congenital or acquired coagulopathy
  • \< 10 g/dL or \< 140,000
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

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

06

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

07

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
    Not yet recruiting
    • Kanyakorn - Riewruja · Contactkanyakorn.riew@gmail.com · +66-95-864-4447
    • Kanyakorn Riewruja, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Aug 2026, 25 months after the start.

Of 63 non-industry interventional studies with no phase under Femoral Neck Fractures, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 62. This study's planned 25 months is below that.

Counting every sponsor, half of 69 studies reached it within 46 months; a quarter within 25 and three quarters within 68.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 25, 2024
First posted
Mar 4, 2024
StartActual
Jul 3, 2024
Primary completionEst.
Aug 31, 2026
CompletionEst.
Jun 30, 2027
Last update
Aug 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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