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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 1, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

October 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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

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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

[ Time Frame: ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A Randomized, Double-Blinded, Placebo-Controlled Trial
Masking: Interventional
Masking Description:triple blinded (Participant, Care Provider, investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Intervention ^ICMJE

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.
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).

Study Arms

Experimental: Glutamine
Intravenous glutamine infusion perioperatively for 18 hours (8 hours before surgery and 10 hours after induction of anesthesia)
Placebo Comparator: Placebo
placebo

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

128

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 2020

Estimated Primary Completion Date

October 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

30 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Korea, Republic of

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

，

Study Sponsor ^ICMJE

Yonsei University

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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