Femoral Fractures, Hemorrhage, Surgical, Tranexamic Acid Use
Conditions
Keywords
Femoral Shaft Fractures, Intramedullary Nailing, Perioperative Hemorrhage, Tranexamic Acid, Orthopedic Surgery, Blood Loss, Surgical, Blood Transfusion, Open Reduction and Internal Fixation, Developing Countries
Brief summary
This clinical study aims to evaluate the safety and effectiveness of administering a single intravenous dose of tranexamic acid (TXA) before surgery to reduce blood loss in patients undergoing open intramedullary nailing for femoral shaft fractures. In many resource-limited settings, including Uganda, this surgical approach is common due to lack of fluoroscopic equipment, and it is known to be associated with significant perioperative blood loss. Tranexamic acid is an antifibrinolytic agent that helps stabilize blood clots and is widely used to reduce bleeding in major surgeries such as joint replacements and spinal procedures. However, its role in trauma-related open femoral surgeries in low-resource settings remains underexplored. This study investigates whether preoperative intravenous TXA can safely reduce blood loss and transfusion needs during and after surgery in patients with isolated femoral shaft fractures managed at Mulago National Referral Hospital.
Detailed description
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.
Interventions
DRUGTranexamic Acid
Intravenous tranexamic acid (Kapron®, Amoun, Egypt) administered as a single dose of 15 mg/kg, diluted in normal saline and given slowly over 10 minutes, approximately 10 minutes prior to skin incision. The drug was supplied in 500 mg/5 mL ampoules and administered by the anesthetist in the operating theater. This intervention was given once before surgery in patients undergoing open intramedullary nail fixation of isolated femoral shaft fractures. No additional doses or postoperative administration of TXA were used.
Sponsors
Mulago Hospital, Uganda
Makerere University
Masaka Regional Referral Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a single-arm, open-label prospective cohort study where all enrolled participants receive the same intervention - a preoperative intravenous dose of tranexamic acid (15 mg/kg) prior to open intramedullary nailing of femoral shaft fractures. There is no control or comparison group within the trial; outcomes are assessed against pre-defined benchmarks or historical controls.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin Concentration from Preoperative to 72 Hours Postoperative | From 2 hours before surgery to 72 hours after surgery | Hemoglobin concentration (g/dL) was measured 2 hours before surgery and again 72 hours after surgery. The difference between these two values was used to estimate total perioperative blood loss. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Requiring Perioperative Blood Transfusion | From 2 hours before surgery to 72 hours after surgery | The percentage of patients who received a blood transfusion during the perioperative period following administration of preoperative intravenous tranexamic acid (15 mg/kg). Blood transfusion indications were based on standardized clinical criteria and hemoglobin thresholds. |
| Incidence and Profile of Adverse Events Following Tranexamic Acid Administration | From 2 hours before surgery to 72 hours after surgery | Capture and categorize any adverse events or side effects observed following the administration of intravenous tranexamic acid. |
Countries
Uganda
Outcome results
None listed