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

NCT07288697 | Completed

• 1 other identifier: KDrLKSH-AVR-BOB-01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Loss, Surgical; Spinal Disorders; Degenerative Spine Disease

Keywords

Tranexamic acid; Spinal surgery; Bleeding; Blood transfusion

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

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

  24 and 48 hours postoperatively

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

  24 and 48 hours postoperatively

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

  24 and 48 hours postoperatively

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

  24 and 48 hours postoperatively

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

  24 and 48 hours postoperatively

Study Arms (2)

low-dose tranexamic acid

ACTIVE COMPARATOR

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

Drug: low-dose TXA

high-dose tranexamic acid

ACTIVE COMPARATOR

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

Drug: high-dose TXA

Interventions

high-dose TXA DRUG

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

Also known as: Tranexamic asid loading, Tranexamic asid infusion

high-dose tranexamic acid

low-dose TXA DRUG

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

Also known as: Tranexamic acid loading, Tranexamic acid infusion

low-dose tranexamic acid

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Kartal Dr. Lütfi Kırdar Şehir Hastanesi

Istanbul, 34865, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Blood Loss, Surgical; Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Doctor

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 17, 2025
• Study Start: November 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)