One Versus Two Doses of Tranexamic Acid in Surgically Treated Extracapsular Hip Fractures (NCT07432737) | Clinical Trial Compass
RecruitingNot Applicable
One Versus Two Doses of Tranexamic Acid in Surgically Treated Extracapsular Hip Fractures
North Macedonia120 participantsStarted 2026-02-17
Plain-language summary
The goal of this clinical trial is to learn whether giving one dose or two doses of tranexamic acid can safely lower blood loss in older adults having surgery for certain hip fractures. The study includes adults aged 65 years or older who need surgery for pertrochanteric or subtrochanteric hip fractures.
The main questions the study aims to answer are:
* Does giving two doses of tranexamic acid lower the need for blood transfusions compared to one dose?
* Does tranexamic acid help keep hemoglobin levels higher after surgery?
* Is tranexamic acid safe in this group of participants? Researchers will compare participants who receive one dose of tranexamic acid with those who receive two doses to see which approach works better and is safe.
Participants will:
* Receive either one dose of tranexamic acid before surgery or two doses, one before and one after surgery
* Have standard surgery to fix their hip fracture within 48 hours of hospital admission
* Be monitored during their hospital stay for blood loss, transfusions, and medical problems
* Be followed for up to 90 days after surgery to check for safety A total of 120 participants will take part in this study, which is being conducted at the University Clinic "St. Naum Ohridski" in Skopje, North Macedonia.
Who can participate
Age range
65 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Written informed consent obtained
* Patients aged 65 years or older
* Patients with pertrochanteric femoral fracture (AO/OTA classification: 31A1.2, 31A1.3, 31A2, 31A3) or subtrochanteric femoral fracture (AO/OTA classification: 32; fractures from the level of the lesser trochanter to 5 cm distally)
* Surgical treatment performed within 48 hours of hospital admission
Exclusion Criteria:
* Age younger than 65 years
* Known allergy or hypersensitivity to tranexamic acid
* Active thromboembolic event (deep vein thrombosis, arterial thrombosis, pulmonary embolism) or history of vascular event within the past year (myocardial infarction, coronary or peripheral vascular stenting, thromboembolism, stroke)
* Impaired renal function defined as serum creatinine \>120 µmol/L in the last preoperative laboratory test
* History of malignant disease
* History of seizure disorder or chronic anticonvulsant therapy
* Polytrauma or multiple trauma
* More than one fracture
* Previous fracture of the same hip
* Preoperative hemoglobin level \<8 g/dL (last laboratory test before surgery)
* Thrombocytopenia or other coagulation disorders
* Treatment with vitamin K antagonists with INR \>1.5
* Treatment with low-molecular-weight heparins without appropriate preoperative discontinuation according to clinical protocol (usually ≥24 hours for prophylactic doses and ≥24-36 hours for therapeutic doses)
* Treatment with direct oral anticoagulants without appropriate preoperative di…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of allogeneic blood transfusion
Timeframe: From start of surgery through postoperative day 5.
Trial details
NCT IDNCT07432737
SponsorUniversity Hospital for Surgical Diseases St. Naum Ohridsk i- Skopje