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.

Study Overview

• Status: Completed
• Conditions: Blood Loss, Surgical; Degenerative Spine Disease; Spinal Disorders
• Intervention / Treatment: Drug: low-dose TXA; Drug: high-dose TXA

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34865
    • Kartal Dr. Lütfi Kırdar Şehir Hastanesi

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: low-dose tranexamic acid; low-dose TXA (n= 31): 5 mg/kg loading + 1 mg/kg/h infusion	Drug: low-dose TXA; low-dose TXA (n= 31): 5 mg/kg loading + 1 mg/kg/h infusion; Other Names: Tranexamic acid loading; Tranexamic acid infusion
Active Comparator: high-dose tranexamic acid; high-dose TXA (n = 31): 10 mg/kg loading +2 mg/kg/h infusion	Drug: high-dose TXA; high-dose TXA (n = 31): 10 mg/kg loading +2 mg/kg/h infusion; Other Names: Tranexamic asid loading; Tranexamic asid infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Blood Loss [Milliliters]	The total amount of blood lost during surgery, measured in milliliters.	During the operation
Number of Patients Requiring Intraoperative Erythrocyte Suspension Transfusion [Number of Participants]	Number of participants who required intraoperative erythrocyte suspension (ES) transfusion.	During the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Hemoglobin Level at 24 and 48 Hours [g/dL]	Hemoglobin values measured at 24 and 48 hours after surgery.	24 and 48 hours postoperatively
Postoperative Hematocrit Level at 24 and 48 Hours [Percent (%)]	Hematocrit levels measured at 24 and 48 hours after surgery.	24 and 48 hours postoperatively
Postoperative Platelet Count at 24 and 48 Hours [×10⁹/L or per mm³]	Platelet count measured at 24 and 48 hours after surgery.	24 and 48 hours postoperatively
Aspartate Aminotransferase (AST) Level at 24 and 48 Hours [U/L]	Biochemical Parameters	24 and 48 hours postoperatively
Alanine Aminotransferase (ALT) Level at 24 and 48 Hours [U/L]	Biochemical Parameters	24 and 48 hours postoperatively
Blood Urea Nitrogen (BUN) Level at 24 and 48 Hours [mg/dL]	Biochemical Parameters	24 and 48 hours postoperatively
Creatinine Level at 24 and 48 Hours [mg/dL]	Biochemical Parameters	24 and 48 hours postoperatively
Incidence of Postoperative Nausea and Vomiting [Number of Participants]	Number of participants experiencing nausea and vomiting within 48 hours after surgery, potentially related to tranexamic acid (TXA) administration.	First 48 hours postoperatively
Incidence of Serious Adverse Events Related to Tranexamic Acid [Number of Participants]	Number of participants experiencing serious adverse events attributable to tranexamic acid use.	First 48 hours postoperatively

Collaborators and Investigators

• Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Bleeding; Tranexamic acid; Blood transfusion; Spinal surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Pathological Conditions, Signs and Symptoms; Hemorrhage; Blood Loss, Surgical
• Other Study ID Numbers: KDrLKSH-AVR-BOB-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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