One versus two doses of tranexamic acid for hip fracture surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, single-center trial enrolling adults aged 65 years and older with pertrochanteric or subtrochanteric femoral fractures who undergo surgery within 48 hours of admission. Participants are randomized to receive either a single prophylactic dose of tranexamic acid before surgery or two doses (one before and one after surgery), with surgical and anesthetic care according to institutional standards. Outcomes include perioperative blood loss, postoperative hemoglobin levels, need for blood transfusion, and safety events such as thromboembolism and seizures, with fractures classified by AO/OTA criteria and care recorded by treating surgeons. Routine preoperative labs and postoperative monitoring are used to compare the efficacy and safety of the two dosing strategies.

Why it matters

Who can join: the full rules

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

Where it's running

• University Clinic PHI University Clinic for Surgical Diseases, St. Naum Ohridski
  Skopje, North Macedonia Recruiting

Study contacts

• Study coordinator: Angelina Krsteva, MD
• Email: drangelinakrsteva@yahoo.com
• Phone: +38971790239

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.