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

NCT07261930 | Completed Phase 4 DMC

• 1 other identifier: MskRRH-ORTHO-2025-001
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhage, Surgical; Tranexamic Acid Use; Femoral Fractures

Keywords

Femoral Shaft Fractures; Intramedullary Nailing; Perioperative Hemorrhage; Tranexamic Acid; Orthopedic Surgery; Blood Loss, Surgical; Blood Transfusion; Open Reduction and Internal Fixation; Developing Countries

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin Concentration from Preoperative to 72 Hours Postoperative

  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.

  From 2 hours before surgery to 72 hours after surgery

Secondary Outcomes (2)

• Proportion of Patients Requiring Perioperative Blood Transfusion

  From 2 hours before surgery to 72 hours after surgery

• Incidence and Profile of Adverse Events Following Tranexamic Acid Administration

  From 2 hours before surgery to 72 hours after surgery

Study Arms (1)

Single Arm: IV TXA Before Femoral Nailing

EXPERIMENTAL

Participants in this arm received a single preoperative intravenous dose of tranexamic acid (Kapron®, Amoun Pharma, Egypt) at 15 mg/kg, administered slowly over 10 minutes approximately 10 minutes before skin incision. The intervention was intended to reduce perioperative blood loss in patients undergoing open intramedullary nail fixation of isolated femoral shaft fractures at Mulago National Referral Hospital, Uganda. All participants received standard perioperative care, including preoperative antibiotics and anesthesia. No control or placebo group was included in this single-arm, open-label study.

Drug: Tranexamic Acid

Interventions

Tranexamic Acid DRUG

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.

Also known as: Kapron

Single Arm: IV TXA Before Femoral Nailing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masaka Regional Referral Hospital: lead
• Mulago Hospital, Uganda: collaborator
• Makerere University: collaborator

Study Sites (1)

Mulago National Referral Hospital

Kampala, Uganda

Location

MeSH Terms

Conditions

Femoral Fractures; Blood Loss, Surgical

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Paul Kabazzi

  Masaka Regional Referral Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: December 3, 2025
• Study Start: October 1, 2018
• Primary Completion: February 28, 2019
• Study Completion: May 1, 2019
• Last Updated: December 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)