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

Posterior Lumbar Spinal Fusion Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03697681
• Other study ID #: 4-2018-0754
• Status: Completed
• Phase: N/A
• Start date: October 16, 2018
• Est. completion date: August 12, 2020

Study information

• Verified date: October 2020
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: August 12, 2020
• Est. primary completion date: August 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Posterior Lumbar Spinal Fusion Surgery

Intervention

Drug:
• Tranexamic acid
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)
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).

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	base blood concentration of syndecan-1, heparan sulfate	preoperative baseline serum levels of syndecan-1 and heparan sulfate	within 1 hour before surgery(base concentration)
Primary	blood concentration of syndecan-1, heparan sulfate at the end of the surgery	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)
Primary	blood concentration of syndecan-1, heparan sulfate at 2 hours after surgery	blood concentration of syndecan-1, heparan sulfate at 2 hours after surgery	2 hours after the end of surgery