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

Not Applicable

Completed

• Conditions: Posterior Lumbar Spinal Fusion Surgery
• Interventions: Drug: Tranexamic acid; Drug: 0.9% NaCl (normal saline)

• Registration Number: NCT03697681
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-01
• Study First Submitted QC: 2018-10-04
• Study First Posted: 2018-10-05
• Study Start: 2018-10-16
• Primary Completion: 2020-08-12
• Study Completion: 2020-08-12
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-15
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glutamine	Tranexamic acid	Intravenous glutamine infusion perioperatively for 18 hours (8 hours before surgery and 10 hours after induction of anesthesia)
Placebo	0.9% NaCl (normal saline)	placebo

Primary Outcome Measures

Name	Time	Method
blood concentration of syndecan-1, heparan sulfate at the end of the surgery	within 5 minutes after the end of surgery (when thd surgical drape is removed)	blood concentration of syndecan-1, heparan sulfate at the end of the surgery
base blood concentration of syndecan-1, heparan sulfate	within 1 hour before surgery(base concentration)	preoperative baseline serum levels of syndecan-1 and heparan sulfate
blood concentration of syndecan-1, heparan sulfate at 2 hours after surgery	2 hours after the end of surgery	blood concentration of syndecan-1, heparan sulfate at 2 hours after surgery

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of