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

NCT07625709 | Completed

• 1 other identifier: 28/23
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Blood Loss, Postoperative; Blood Loss, Surgical; Femoral Fracture; Tibial Fracture

Keywords

Femur; Fracture; Intramedullary Nailing; Surgical blood loss; Tibia; Tranexamic acid

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Adverse Effects Related to Tranexamic Acid

  2 years

Study Arms (2)

Tranexamic Acid Group

EXPERIMENTAL

Drug: Intervention with Tranexamic Acid

Placebo/ Standard Care group

PLACEBO COMPARATOR

Drug: Control group (Normal Saline)

Interventions

Intervention with Tranexamic Acid DRUG

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.

Tranexamic Acid Group

Control group (Normal Saline) DRUG

This group receives 50ml of normal saline and is labeled as standard care group.

Placebo/ Standard Care group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kathmandu University School of Medical Sciences: lead

Study Sites (1)

Dhulikhel Hospital, Kathmandu University Hospital

Dhulikhel, Bagmati, 45200, Nepal

Location

Related Publications (3)

• 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.

  PMID: 28938281 RESULT

• 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.

  PMID: 40763214 RESULT

• 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.

  PMID: 33532495 RESULT

MeSH Terms

Conditions

Postoperative Hemorrhage; Blood Loss, Surgical; Femoral Fractures; Tibial Fractures; Fractures, Bone

Interventions

Methods; Tranexamic Acid; Control Groups; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 4, 2026
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: January 1, 2025
• Last Updated: June 4, 2026

Record last verified: 2026-04

Locations

NE (1)