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

Study Overview
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Brief Summary
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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.

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

Conditions
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Posterior Lumbar Spinal Fusion Surgery

Intervention / Treatment
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* Drug: Tranexamic acid
* Drug: 0.9% NaCl (normal saline)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Randomized, Double-Blinded, Placebo-Controlled Trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glutamine<br>Intravenous glutamine infusion perioperatively for 18 hours (8 hours before surgery and 10 hours after induction of anesthesia) | Drug: Tranexamic acid<br>* 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.<br>* Other names: glutamine;|
| Placebo Comparator: Placebo<br>placebo | Drug: 0.9% NaCl (normal saline)<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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 |