Protective Effect of Tranexamic Acid on Shedding of the Endothelial Glycocalyx in Patients Undergoing Spinal Fusion Surgery

Yonsei University128 enrolled

Overview

The aim of this study was to determine whether the administration of tranexamic acid in patients undergoing lumbar spinal fusion surgery can inhibit damage in endothelial glycocalyx layer. As a prospective double blinded randomized placebo-controlled trial, the investigators detect and compare the changes in concentrations of serum syndecan-1 and heparan sulfate before and after surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

128

Conditions

Posterior Lumbar Spinal Fusion Surgery

Interventions

Tranexamic acidDRUG

Intravenous infusion of Tranexamic acid(mixed with normal saline) at the dose of 10mg/kg(body weight) for 20 min after induction of anesthesia and then administration another 1mg/kg/hr(body weight) of Tranexamic acid(mixed with normal saline) until the end of the operation.

0.9% NaCl (normal saline)DRUG

The same amount of normal saline solution without the addition of tranexamic acid is administered in the same manner as the experimental group(Tranexamic acid intervention group).

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients with between 30 and 80 years scheduled for posterior lumbar spinal fusion surgery. Exclusion Criteria: * emergency surgery * patients unable to make their own decisions, illiterate, foreigners * Allergy / hypersensitivity to Tranexamic acid * Current or past history or thrombosis / thromboembolism * patients who are taking oral contraceptives * Patients with renal insufficiency (eGFR 60 ml / min / 1.73 m 2 or less) * Patients receiving anticoagulants * pregnant and lactating women

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, South Korea

Outcomes

Primary Outcomes

base blood concentration of syndecan-1, heparan sulfate

preoperative baseline serum levels of syndecan-1 and heparan sulfate

Time frame: within 1 hour before surgery(base concentration)

blood concentration of syndecan-1, heparan sulfate at the end of the surgery

Time frame: within 5 minutes after the end of surgery (when thd surgical drape is removed)

blood concentration of syndecan-1, heparan sulfate at 2 hours after surgery

Time frame: 2 hours after the end of surgery

Data from ClinicalTrials.gov

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