Endothelial Damage in Major Spine Surgery, Measured by Circulating Syndecan-1: an Observational Study.(GlycOrtho)

Study Overview
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Brief Summary
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The goal of this observational study is to learn about endothelial damage in major spine surgery, expressed as rise in circulating Syndecan-1. The main questions it aims to answer are: What is the extent of endothelial glycocalyx shedding in major spine surgery? Are there differences in different type of surgical populations? (adolescent idiopathic scoliosis, adult degenerative spine disease, oncologic surgery) To do so, blood samples will be drawn from participants at the following timepoints: basal after surgery if transfusion of Fresh Frozen Plasma: before and after transfusion Post-Operative Day 1-2-4

Detailed Description
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The aim of this study is to gain information about endothelial damage in major spine surgery, expressed as shedding of glycocalyx component Syndecan-1, and subsequent rise of its plasma levels. This phenomenon has been extensively described in shock states (sepsis, trauma, cardiac arrest ..) but little is known about endothelial damage in elective major surgery. This study was designed to study the magnitude of Syndecan-1 rise after spine surgery, divided in three main categories: adolescent idiopathic scoliosis, adult degenerative and oncologic surgery. The investigators were also interested in the effect of Fresh Frozen Plasma transfusion on Syndecan-1 levels, since previous studies have indicated a potential benefit on endothelial integrity. The results of this study will be used to inform subsequent clinical trials designed to investigate the effect of different intraoperative conducts on endothelial damage.

Official Title
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Endothelial Glycocalyx Damage in Major Spine Surgery, as Measured by Circulating Syndecan-1 Levels: a Prospective Observational Pilot Study.(GlycOrtho)

Conditions
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Spinal Fusion

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing Major Spine Surgery with estimated blood loss> 25% of total blood volume American Society of Anesthesiology status 1-2-3 Able to comprehend and sign informed consent. If age <18 years: parent or legal representative able to comprehend and sign informed consent Exclusion Criteria: Surgery outside of laboratory opening hours Patients undergoing spine surgery for genetic syndromes/neuromuscular scoliosis

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 75 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delta Syndecan-1 before -after surgery | Difference between basal Syndecan-1 level and level at the end of surgery | baseline, day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-Operative Syndecan-1 curve | Variation of Syndecan-1 levels at post-operative days 1-2-4 | baseline, day 1, day2, day 3, day 5 | 
| Population differences | Difference in baseline and post-operative Syndecan-1 levels in different populations | baseline, day 1, day2, day 3, day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endothelium, Syndecan-1, Surgery, Glycocalyx