EFFECT OF TRANEXAMIC ACID ON PERIOPERATIVE BLOOD LOSS IN REAMED INTRAMEDULLARY NAILING OF DIAPHYSEAL FEMORAL AND TIBIAL FRACTURES: A PROSPECTIVE COMPARATIVE STUDY

Effect of Tranexamic Acid on Perioperative Blood Loss in Reamed Intramedullary Nailing of Diaphyseal Femoral and Tibial Fractures: A Prospective Comparative Study.

Perioperative blood loss is one of the most frequently encountered and significant complications of spine surgery. Intraoperative and post-operative bleeding cause various complications and negatively affect patient outcomes. There are a range of methods that can be employed to both reduce the risk of bleeding and achieve hemostasis, one of which is the adjunct use of hemostatic agents. Intravenous administration of transxamic acid appears to reduce perioperative damage and the need for blood transfusions in spine surgery. The study is done in patients admitted to Dhulikhel Hospital undergoing elective open spine surgery, to study the efficacy of tranexamic acid in reducing blood loss and need of blood transfusion in patients undergoing spine surgery. Patients undergoing spine surgeries are enrolled and allocated by computer generated randomization into 2 groups, (a) placebo group, receiving 0.9% NaCl, (b) tranexamic acid group, receiving 2 doses of tranexamic acid(15mg/kg). Intraoperative and post-operative blood loss are measured. Study parameters include estimated blood loss, hemoglobin, hematocrit and number of blood transfusions required in post-operative setting. Study parameters are compared across two groups using appropriate statistical tools. This study will help us determine the role of tranexamic acid in reducing perioperative blood loss and need for blood transfusion in patients undergoing spine surgery.

HYPOTHESES OF THE STUDY:

Null hypothesis (H0): There is no significant effect of tranexamic acid in reduction of blood loss compared to study group Alternate hypothesis (H1): There is significant improved effect of tranexamic acid in reduction of blood loss.

Hence, H0 : Mean of Parameters of Control groups >= mean of parameters of Study groups.

H1: Mean of parameters of Control groups < Mean of parameters of Study groups

Study Overview

• Status: Completed
• Conditions: Femoral Fracture; Blood Loss, Surgical; Blood Loss, Postoperative; Tibial Fracture
• Intervention / Treatment: Drug: Intervention with Tranexamic Acid; Drug: Control group (Normal Saline)

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nepal
  • Bagmati
    • Dhulikhel, Bagmati, Nepal, 45200
      • Dhulikhel Hospital, Kathmandu University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 16-60 years
• Patients with isolated diaphyseal fracture (Shaft fracture of femur or Shaft fracture of tibia)
• Patients planned for reamed intramedullary nailing
• Patients willing to provide informed consent

Exclusion Criteria:

• Patients with polytrauma
• Fractures requiring open reduction
• Gustilo-Anderson Grade III open fractures
• Known history of coagulopathy
• International Normalized Ratio (INR) > 1.2
• Current use of anticoagulant therapy
• Current use of antiplatelet therapy
• Presence of major hepatic failure
• Presence of major renal failure
• Patients unwilling or unable to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic Acid Group	Drug: Intervention with Tranexamic Acid; In Tranexamic acid (TXA) group, single intravenous dose of Tranexamic Acid (15mg/kg) diluted in 50 ml of normal saline is administered 30 minutes prior to the induction of anesthesia.
Placebo Comparator: Placebo/ Standard Care group	Drug: Control group (Normal Saline); This group receives 50ml of normal saline and is labeled as standard care group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Blood Loss Measured in Milliliters (mL)	Intraoperative blood loss during spine surgery will be measured in milliliters (mL) using suction drain collection and surgical sponge estimation. Lower blood loss indicates better efficacy of tranexamic acid in reducing surgical bleeding.	2 years
Postoperative Blood Loss Measured in Milliliters (mL)	Postoperative blood loss will be assessed in milliliters (mL) from surgical drain output collected during the first 24 hours following surgery. Lower postoperative blood loss indicates better efficacy of tranexamic acid.	2 years
Change in Hemoglobin Level Measured in Grams per Deciliter (g/dL)	Reduction in hemoglobin level will be assessed by comparing preoperative and postoperative hemoglobin values measured in grams per deciliter (g/dL). Smaller reduction in hemoglobin indicates lower perioperative blood loss.	2 years
Intraoperative Blood Transfusion Requirement	Blood transfusion requirement during surgery will be measured as the number of blood units transfused intraoperatively. Lower transfusion requirement indicates better blood conservation.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Effects Related to Tranexamic Acid	Adverse events related to tranexamic acid administration, including thromboembolic events, allergic reactions, or other drug-related complications, will be recorded during hospital stay and follow-up.	2 years

Collaborators and Investigators

• Sponsor: Kathmandu University School of Medical Sciences

Publications and helpful links

General Publications

• Gausden EB, Qudsi R, Boone MD, O'Gara B, Ruzbarsky JJ, Lorich DG. Tranexamic Acid in Orthopaedic Trauma Surgery: A Meta-Analysis. J Orthop Trauma. 2017 Oct;31(10):513-519. doi: 10.1097/BOT.0000000000000913.
• Boucher M, Tremblay J, Pelet T, Dartus J, Belzile EL, Pelet S. Topical Versus Systemic Tranexamic Acid to Reduce Blood Loss After Total Knee and Total Hip Arthroplasty: A Systematic Review and Meta-Analysis. J Bone Joint Surg Am. 2025 Oct 15;107(20):2300-2309. doi: 10.2106/JBJS.24.01511. Epub 2025 Aug 5.
• Reale D, Andriolo L, Gursoy S, Bozkurt M, Filardo G, Zaffagnini S. Complications of Tranexamic Acid in Orthopedic Lower Limb Surgery: A Meta-Analysis of Randomized Controlled Trials. Biomed Res Int. 2021 Jan 16;2021:6961540. doi: 10.1155/2021/6961540. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: May 24, 2026
• First Submitted That Met QC Criteria: May 31, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 31, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Fracture; Tranexamic acid; Tibia; Femur; Intramedullary Nailing; Surgical blood loss
• Additional Relevant MeSH Terms: Wounds and Injuries; Postoperative Complications; Pathologic Processes; Leg Injuries; Hemorrhage; Intraoperative Complications; Pathological Conditions, Signs and Symptoms; Fractures, Bone; Femoral Fractures; Tibial Fractures; Blood Loss, Surgical; Postoperative Hemorrhage; Organic Chemicals; Pharmaceutical Preparations; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Carboxylic Acids; Crystalloid Solutions; Isotonic Solutions; Solutions; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Tranexamic Acid; Methods; Control Groups; Saline Solution
• Other Study ID Numbers: 28/23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No