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NCT Number: NCT07625709

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

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Key information

Conditions

Blood Loss, Postoperative Blood Loss, Surgical Femoral Fracture Femoral Fractures Fractures, Bone Hemorrhage Intraoperative Complications Leg Injuries Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage Tibial Fracture Tibial Fractures Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dhulikhel Hospital, Kathmandu University Hospital

Dhulikhel, Bagmati, 45200, Nepal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Control group (Normal Saline)

Drug

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

Primary outcomes

  1. Intraoperative Blood Loss Measured in Milliliters (mL)

    Time frame: 2 years

    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. Postoperative Blood Loss Measured in Milliliters (mL)

    Time frame: 2 years

    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.

  3. Change in Hemoglobin Level Measured in Grams per Deciliter (g/dL)

    Time frame: 2 years

    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.

  4. Intraoperative Blood Transfusion Requirement

    Time frame: 2 years

    Blood transfusion requirement during surgery will be measured as the number of blood units transfused intraoperatively. Lower transfusion requirement indicates better blood conservation.

Secondary outcomes

  1. Adverse Effects Related to Tranexamic Acid

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

Kathmandu University School of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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