Femoral Neck FractureTXANCT06289478
Efficacy and Safety of Topical Tranexamic Acid (TXA) Administration Cementless Bipolar Hemiarthroplasty for Femoral Neck Fracture - a Randomized Controlled Trial
A study testing Retrograde Intraarticular Injection via Drain Tube and Topical Soaking of Tranexamic Acid in people with Femoral Neck Fracture, run by King Chulalongkorn Memorial Hospital at 2 sites in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Femoral Neck Fracture
- What is being tested?
- Retrograde Intraarticular Injection via Drain Tube and Topical Soaking of Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 2 sitesThailand
- Study dates
- 3 Jul 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elderly patients (age \> 60 years)
- Femoral neck fractures from low energy mechanism
- Household ambulator
- Undergoing cementless bipolar hemiarthroplasty at KCMH
- Informed consent
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Tantavisut, MD., PhD. contact
Thailand2 sites, 2 recruiting
- Recruiting
Faculty of Medicine, King Chulalongkorn Memorial Hospital
Bangkok, Bangkok, 10330
Kanyakorn Riewruja, MD, Doctor of Medicine, 0958644447, kanyakorn.riew@gmail.com
- Not yet recruiting
Faculty of Medicine
Bangkok, Bangkok, 10330
Kanyakorn - Riewruja, +66-95-864-4447, kanyakorn.riew@gmail.com
Kanyakorn Riewruja, MD
About this study
Official title: 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
Read more
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.
- Conditions
- Femoral Neck Fracture
- Being tested
- Retrograde Intraarticular Injection via Drain Tube, Topical Soaking of Tranexamic Acid, Placebo Comparator: Standard procedure (placebo)
- Keywords
- tranexamic acid, femoral neck fracture, bipolar hemiarthroplasty, topical, blood transfusion
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde Intraarticular Injection via Drain TubeDrug
Tranexamic acid will be injected via drain tube after wound closure
Topical Soaking of Tranexamic AcidDrug
Tranexamic acid will be topically administered by soaking method
Placebo Comparator: Standard procedure (placebo)Drug
Standard wound management
| Study group | Role | What they receive |
|---|---|---|
| Retrograde Intraarticular Injection via Drain Tube | Experimental | Tranexamic acid will be injected retrograde to the joint via drain tube after surgical wound closure Receives: Drug: Retrograde Intraarticular Injection via Drain Tube |
| Topical Soaking of Tranexamic Acid | Experimental | 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 Receives: Drug: Topical Soaking of Tranexamic Acid |
| Standard procedure (placebo) | Placebo comparator | Standard wound irrigation Receives: Drug: Placebo Comparator: Standard procedure (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of blood transfusion
Proportion of patients received blood transfusion divided by total number of patient in a group
Measured: 2 years, or until complete enrollment
Secondary outcomes (4)
Volume of blood transfusion
total volume of blood transfusion per each patient
Measured: 2 years, or until complete enrollment
Calculated blood loss
Calculating using Nadler and Goss formula
Measured: 2 years, or until complete enrollment
Any adverse events
Adverse events include wound complication, deep vein thrombosis, pulmonary embolism, and other complication
Measured: 2 years, or until complete enrollment
In-hospital mortality
In-hospital mortality
Measured: During admission period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start3 Jul 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Chulalongkorn Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kanyakorn Riewruja, King Chulalongkorn Memorial Hospital
- Investigators
- Kanyakorn Riewruja, Medical degree, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289478
- Sponsor's protocol ID
- 0151/67
- Acronym
- TXA
- Status last verified
- Aug 2026
- First submitted
- 25 Feb 2024
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06289478
- Acronym / sponsor ID
- TXA / 0151/67
- Conditions
- Femoral Neck Fracture
- Keywords
- tranexamic acid, femoral neck fracture, bipolar hemiarthroplasty, topical, blood transfusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- King Chulalongkorn Memorial HospitalUniversity, hospital or other
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Retrograde Intraarticular Injection via Drain Tube | Experimental | Drug: Retrograde Intraarticular Injection via Drain TubeTranexamic acid will be injected retrograde to the joint via drain tube after surgical wound closure |
| Topical Soaking of Tranexamic Acid | Experimental | Drug: Topical Soaking of Tranexamic AcidTranexamic 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 |
| Standard procedure (placebo) | Placebo comparator | Drug: Placebo Comparator: Standard procedure (placebo)Standard wound irrigation |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Elderly patients (age \> 60 years)
- Femoral neck fractures from low energy mechanism
- Household ambulator
- Undergoing cementless bipolar hemiarthroplasty at KCMH
- Informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrograde Intraarticular Injection via Drain TubeTranexamic acid will be injected via drain tube after wound closure | Drug | Retrograde Intraarticular Injection via Drain Tube |
| Topical Soaking of Tranexamic AcidTranexamic acid will be topically administered by soaking method | Drug | Topical Soaking of Tranexamic Acid |
| Placebo Comparator: Standard procedure (placebo)Standard wound management | Drug | Standard procedure (placebo) |
Primary outcome
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
4 secondary outcomes
Volume of blood transfusion
Time frame: 2 years, or until complete enrollment
Calculated blood loss
Time frame: 2 years, or until complete enrollment
Any adverse events
Time frame: 2 years, or until complete enrollment
In-hospital mortality
Time frame: During admission period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tantavisut, MD., PhD. contact
Kanyakorn Riewruja, Medical degree principal investigator
Chulalongkorn University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retrograde Intraarticular Injection via Drain Tube and Topical Soaking of Tranexamic Acid in people with Femoral Neck Fracture, run by King Chulalongkorn Memorial Hospital at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Riewruja, Medical degree (+66958644447, kanyakorn.riew@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of blood transfusion (time frame: 2 years, or until complete enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.