Effectiveness of Tranexamic Acid in Reducing Blood Loss During Femoral Nail Surgery

This is a prospective, open-label, single-arm cohort study designed to assess the safety and effectiveness of preoperative intravenous tranexamic acid (TXA) in adult patients undergoing open intramedullary nailing for femoral shaft fractures in a resource-limited hospital setting.

The study enrolled 43 adult participants with isolated, closed femoral shaft fractures scheduled for surgical fixation at Mulago National Referral Hospital. Each participant received a single dose of intravenous tranexamic acid (15 mg/kg), administered over 10 minutes approximately 10 minutes prior to skin incision. The dose was prepared and delivered by the anesthetist in the operating theatre.

The primary objective of the study is to estimate perioperative blood loss, assessed by comparing preoperative hemoglobin concentration (taken 2 hours before surgery) to postoperative hemoglobin (taken 72 hours after surgery). Secondary objectives include assessing the proportion of patients requiring blood transfusions and documenting any adverse events associated with TXA administration, such as hypotension, nausea, or allergic reactions.

Surgical procedures were performed using either antegrade or retrograde open intramedullary nailing techniques. Standard perioperative care was provided, including preoperative antibiotics and either spinal or general anesthesia. All blood draws were conducted under aseptic conditions. Transfusion decisions followed standard clinical protocols based on clinical signs and hemoglobin thresholds.

This study is intended to inform clinical practice in low-resource settings by providing data on the potential utility of tranexamic acid in orthopedic trauma surgery where blood conservation is especially critical.

Inclusion criteria

• Adults aged 18 years and above
• Patients with isolated, closed femoral shaft fractures
• Scheduled for open intramedullary nail fixation at Mulago National Referral Hospital
• Able and willing to provide written informed consent

Exclusion criteria

• Injury duration of more than one month
• Patients undergoing repeat surgery for a femoral fracture
• Pathological fractures of the femur
• Patients undergoing ORIF for more than one fracture during the perioperative period
• Known allergy to tranexamic acid
• History of bleeding disorders
• Presence of significant medical comorbidities (e.g., diabetes mellitus, history of deep vein thrombosis, or pulmonary embolism)
• Current use of anticoagulant medications