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

NCT ID: NCT07261930

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-05-01

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.

Conditions

Femoral Fractures; Hemorrhage, Surgical; Tranexamic Acid Use

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm: IV TXA Before Femoral Nailing

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.

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: 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.

Interventions

Tranexamic 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.

Intervention Type: DRUG

Other Intervention Names

Kapron

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mulago Hospital, Uganda

OTHER

Sponsor Role: collaborator

Makerere University

OTHER

Sponsor Role: collaborator

Masaka Regional Referral Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Kabazzi Kaweesa Paul

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul Kabazzi

Role: PRINCIPAL_INVESTIGATOR

Masaka Regional Referral Hospital

Locations

Mulago National Referral Hospital

Kampala, , Uganda

Countries

Uganda

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

MskRRH-ORTHO-2025-001

Identifier Type: -

Identifier Source: org_study_id