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

October 15, 2020 updated by: Yonsei University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
placebo
Drug: 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).
Experimental: Glutamine
Intravenous glutamine infusion perioperatively for 18 hours (8 hours before surgery and 10 hours after induction of anesthesia)
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.
Other Names:
  • glutamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
base blood concentration of syndecan-1, heparan sulfate
Time Frame: within 1 hour before surgery(base concentration)
preoperative baseline serum levels of syndecan-1 and heparan sulfate
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 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 2 hours after surgery
Time Frame: 2 hours after the end of surgery
blood concentration of syndecan-1, heparan sulfate at 2 hours after surgery
2 hours after the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2018

Primary Completion (Actual)

August 12, 2020

Study Completion (Actual)

August 12, 2020

Study Registration Dates

First Submitted

October 1, 2018

First Submitted That Met QC Criteria

October 4, 2018

First Posted (Actual)

October 5, 2018

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 15, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2018-0754

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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