NCT07288697

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Spinal Disorders
• Degenerative Spine Disease
• Blood Loss, Surgical

Interventions

Type	Name	Description
DRUG	low-dose TXA	low-dose TXA (n= 31): 5 mg/kg loading + 1 mg/kg/h infusion
DRUG	high-dose TXA	high-dose TXA (n = 31): 10 mg/kg loading +2 mg/kg/h infusion

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2025-12-17
• Last updated: 2025-12-17

Locations

1 site across 1 country: Turkey (Türkiye)