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NCT Number: NCT07288697

Dose-Dependent Effects of Intraoperative Tranexamic Acid on Surgical Bleeding and Transfusion Requirements in Multilevel Thoracolumbar Spinal Surgery

Multilevel spinal stabilization surgery is frequently associated with substantial blood loss and increased transfusion requirements. Tranexamic acid (TXA), an antifibrinolytic agent, reduces perioperative bleeding, but the optimal intravenous dosing regimen remains controversial.

This study aimed to compare the efficacy and safety of two TXA dosing protocols in patients undergoing ≥3-level spinal stabilization surgery.

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Key information

Conditions

Spinal Disorders Blood Loss, Surgical Degenerative Spine Disease Hemorrhage Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kartal Dr. Lütfi Kırdar Şehir Hastanesi

Istanbul, 34865, Turkey (Türkiye)

About this study

Multilevel spinal stabilization surgery is frequently associated with substantial blood loss and increased transfusion requirements. Tranexamic acid (TXA), an antifibrinolytic agent, reduces perioperative bleeding, but the optimal intravenous dosing regimen remains controversial.

This study aimed to compare the efficacy and safety of two TXA dosing protocols in patients undergoing ≥3-level spinal stabilization surgery.In this prospective, randomized trial, 62 adult patients scheduled for elective thoracolumbar stabilization involving three or more levels were assigned to receive either low-dose TXA (n= 31): 5 mg/kg loading + 1 mg/kg/h infusion or high-dose TXA (n = 31): 10 mg/kg loading +2 mg/kg/h infusion.TXA was administered intravenously 15 minutes before incision.

Intraoperative blood loss, transfusion requirements, perioperative laboratory values, and complications (thromboembolic, neurological, renal, allergic, and seizure-related) were recorded. Patients were monitored for 48 hours postoperatively.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Between 18-65 years
  • Scheduled for elective ≥3-level spinal stabilization surgery under general anesthesia

Exclusion criteria

  • History of thromboembolic events
  • Myocardial infarction
  • Stroke
  • Hepatic or renal failure,
  • Known allergy to TXA
  • Bleeding or coagulation disorders,
  • ASA physical status IV
  • Trauma or tumor surgery
  • Refusal to provide informed consent

Treatment and study plan

low-dose TXA

Drug

low-dose TXA (n= 31): 5 mg/kg loading + 1 mg/kg/h infusion

Other names: Tranexamic acid loading, Tranexamic acid infusion

high-dose TXA

Drug

high-dose TXA (n = 31): 10 mg/kg loading +2 mg/kg/h infusion

Other names: Tranexamic asid loading, Tranexamic asid infusion

Primary outcomes

  1. Intraoperative Blood Loss [Milliliters]

    Time frame: During the operation

    The total amount of blood lost during surgery, measured in milliliters.

  2. Number of Patients Requiring Intraoperative Erythrocyte Suspension Transfusion [Number of Participants]

    Time frame: During the operation

    Number of participants who required intraoperative erythrocyte suspension (ES) transfusion.

Secondary outcomes

  1. Postoperative Hemoglobin Level at 24 and 48 Hours [g/dL]

    Time frame: 24 and 48 hours postoperatively

    Hemoglobin values measured at 24 and 48 hours after surgery.

  2. Postoperative Hematocrit Level at 24 and 48 Hours [Percent (%)]

    Time frame: 24 and 48 hours postoperatively

    Hematocrit levels measured at 24 and 48 hours after surgery.

  3. Postoperative Platelet Count at 24 and 48 Hours [×10⁹/L or per mm³]

    Time frame: 24 and 48 hours postoperatively

    Platelet count measured at 24 and 48 hours after surgery.

  4. Aspartate Aminotransferase (AST) Level at 24 and 48 Hours [U/L]

    Time frame: 24 and 48 hours postoperatively

    Biochemical Parameters

  5. Alanine Aminotransferase (ALT) Level at 24 and 48 Hours [U/L]

    Time frame: 24 and 48 hours postoperatively

    Biochemical Parameters

  6. Blood Urea Nitrogen (BUN) Level at 24 and 48 Hours [mg/dL]

    Time frame: 24 and 48 hours postoperatively

    Biochemical Parameters

  7. Creatinine Level at 24 and 48 Hours [mg/dL]

    Time frame: 24 and 48 hours postoperatively

    Biochemical Parameters

  8. Incidence of Postoperative Nausea and Vomiting [Number of Participants]

    Time frame: First 48 hours postoperatively

    Number of participants experiencing nausea and vomiting within 48 hours after surgery, potentially related to tranexamic acid (TXA) administration.

  9. Incidence of Serious Adverse Events Related to Tranexamic Acid [Number of Participants]

    Time frame: First 48 hours postoperatively

    Number of participants experiencing serious adverse events attributable to tranexamic acid use.

Sponsors and collaborators

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 17, 2025
Registry last updated
Dec 17, 2025

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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