Therapeutic evidence of tranexamic acid effectiveness in reducing postoperative blood loss among patients with femoral shaft fractures: a randomized clinical trial

Abstract

Objective We aimed to evaluate the effect of tranexamic acid on decreasing surgery-related blood loss among patients diagnosed with femoral shaft fracture. Patients and methods This double-blinded, randomized, clinical trial was designed on 60 patients, who have been referred for femoral shaft fracture surgery to the Arak Valiasr Hospital. The eligible patients were assigned into intervention and control groups using balanced block randomization. For patients administered 10 mg/kg of intravenous tranexamic acid slowly to the first group before the surgery, when strict control of vital signs and standard monitoring were utilized throughout the procedure. The amount of blood loss during and after the surgery (6 and 24 h later) and hemoglobin and hematocrit at, before, and after the procedure was measured, and data was analyzed by SPSS 22 (IBM Corp.). Results The clinical evidence revealed lower levels of hemoglobin and hematocrit in the control than in the intervention group within postoperative 24 h (P=0.001), while less blood loss was observed in the intervention group during surgery and at 6 and 24 h later (P=0.001). Conclusion Our results highlight strong support for the hypothesis that in femoral shaft fractures, a tranexamic acid regime significantly decreases blood loss, and subsequently a postoperative improvement in hemoglobin and hematocrit levels was made in patients in the intervention group versus those in the control group. Hence, tranexamic acid administration seems to be an excellent, safe option for controlling bleeding in orthopedic surgeries, where a possible intraoperative blood loss is expected and the clinical circumstances of the patient allow them.