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.
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
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
Parallel
Tranexamic acid
Drug15 mg/kg intravenous solution (100 mg/ml)
Incidence of allogeneic blood transfusion
Comparison of the incidence of intraoperative and postoperative allogeneic transfusions (≥1 unit of red blood cells) between patients receiving a single intravenous dose of tranexamic acid (15 mg/kg, pre-incision) and those receiving two doses (15 mg/kg pre-incision + 15 mg/kg 3 hours after the first dose).
Hemoglobin drop
Comparison of the hemoglobin decrease between participants receiving a single dose versus those receiving two doses of tranexamic acid, measured preoperatively and on postoperative days 1, 2, and 3
Total and hidden blood loss
Comparison of total and hidden blood loss between single-dose and two-dose groups.
Volume of transfused blood products
Comparison of total volume of transfused blood products (fresh frozen plasma, platelet concentrates) between groups.
Length of hospital stay
Comparison of duration of hospitalization in days between groups.
Click on the lead sponsor to view all of their trials.