One versus two doses of tranexamic acid for hip fracture surgery

Prophylactic Administration of One Versus Two Doses of Tranexamic Acid in Surgically Treated Patients With Pertrochanteric and Subtrochanteric Femoral Fractures

This will test whether giving one dose or two doses of tranexamic acid around surgery helps people aged 65 and older with pertrochanteric or subtrochanteric hip fractures lose less blood and need fewer transfusions.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: University Hospital for Surgical Diseases St. Naum Ohridsk i- Skopje (other)
• Locations: 1 site (Skopje)
• Trial ID: NCT07432737 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients aged 65 or older with a pertrochanteric or subtrochanteric femoral fracture who can undergo surgical fixation within 48 hours and have no contraindications to tranexamic acid.

Not a fit: Patients with recent thromboembolic events, impaired renal function, seizure disorders, active malignancy, or known allergy to tranexamic acid are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, two-dose dosing could reduce blood loss and transfusion needs after hip fracture surgery, potentially lowering complications and speeding recovery for older patients.

How similar studies have performed: Numerous orthopedic trials and meta-analyses have shown tranexamic acid reduces blood loss and transfusion requirements in hip fracture and arthroplasty patients, although optimal dosing and safety in older high-risk patients continue to be studied.

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

Where this trial is running

Skopje

• University Clinic PHI University Clinic for Surgical Diseases, St. Naum Ohridski — Skopje, North Macedonia (RECRUITING)

Study contacts

• Study coordinator: Angelina Krsteva, MD

Conditions: Hip Fractures, tranexamic acid, blood loss, blood transfusion, safety