NCT07432737 One Versus Two Doses of Tranexamic Acid in Surgically Treated Extracapsular Hip Fractures

Eligibility & Interventions

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This trial targets 120 participants in total. It began in 2026-02-17 with a primary completion date of 2027-05.

Brief 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.

Eligibility Criteria

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 discontinuation (usually 24-48 hours, depending on renal function and bleeding risk) * Treatment with P2Y12 inhibitors (e.g., ticagrelor, clopidogrel, prasugrel) when, according to anesthesiologist assessment, surgery cannot be safely performed within 48 hours

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