Evaluating the use of tranexamic acid in elderly patients with femoral neck fractures undergoing surgery
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
This study is testing if a medication called tranexamic acid can help older patients with hip fractures have less bleeding and need fewer blood transfusions during surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | King Chulalongkorn Memorial Hospital Academic / other |
| Locations | 2 sites (Bangkok and 1 other locations) |
| Trial ID | NCT06289478 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of tranexamic acid (TXA) administered either through retrograde intraarticular injection or topical soaking in elderly patients with femoral neck fractures undergoing cementless bipolar hemiarthroplasty. The study aims to determine if TXA can reduce the need for blood transfusions during and after surgery. Participants will be randomly assigned to receive either the TXA treatment or a placebo, allowing researchers to compare outcomes effectively. The focus is on household ambulatory elderly patients who meet specific inclusion criteria.
Who should consider this trial
Good fit: Ideal candidates are elderly patients over 60 years old with femoral neck fractures from low-energy mechanisms who are household ambulators.
Not a fit: Patients with allergies to TXA, history of venous thromboembolism, or significant blood disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the need for blood transfusions in elderly patients undergoing hip surgery.
How similar studies have performed: Previous studies have shown promising results with the use of tranexamic acid in reducing blood loss in surgical settings, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bangkok and 1 other locations
- Faculty of Medicine, King Chulalongkorn Memorial Hospital — Bangkok, Thailand (Recruiting)
- Faculty of Medicine — Bangkok, Thailand (Not_yet_recruiting)
Study contacts
- Study coordinator: Kanyakorn Riewruja, Medical degree
- Email: kanyakorn.riew@gmail.com
- Phone: +66958644447
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.