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

NCT ID: NCT07288697

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-04-01

Brief Summary

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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

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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

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Spinal Disorders Degenerative Spine Disease Blood Loss, Surgical

Keywords

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Tranexamic acid Spinal surgery Bleeding Blood transfusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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low-dose tranexamic acid

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

Group Type ACTIVE_COMPARATOR

low-dose TXA

Intervention Type DRUG

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

high-dose tranexamic acid

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

Group Type ACTIVE_COMPARATOR

high-dose TXA

Intervention Type DRUG

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

Interventions

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low-dose TXA

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

Intervention Type DRUG

high-dose TXA

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

Intervention Type DRUG

Other Intervention Names

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Tranexamic acid loading Tranexamic acid infusion Tranexamic asid loading Tranexamic asid infusion

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Lutfi Kirdar Kartal Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Belgüzar Özsert Bilgin

Assistant Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kartal Dr. Lütfi Kırdar Şehir Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KDrLKSH-AVR-BOB-01

Identifier Type: -

Identifier Source: org_study_id