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

Republic of Turkey Ministry of Health

Status: Completed

Conditions: Degenerative Spine Disease; Spinal Disorders; Blood Loss, Surgical

Treatments: Drug: high-dose TXA; Drug: low-dose TXA

Study type: Interventional

Funder types: Other

Identifiers

NCT07288697

KDrLKSH-AVR-BOB-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

low-dose tranexamic acid

Active Comparator group

Description:

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

Treatment:

Drug: low-dose TXA

high-dose tranexamic acid

Active Comparator group

Description:

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

Treatment:

Drug: high-dose TXA