Endothelial Glycocalyx Damage in Major Spine Surgery, as Measured by Circulating Syndecan-1 Levels: a Prospective Observational Pilot Study.(GlycOrtho)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Istituto Ortopedico Rizzoli
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Delta Syndecan-1 before -after surgery
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 12 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Delta Syndecan-1 before -after surgery
Time Frame: baseline, day 1
Difference between basal Syndecan-1 level and level at the end of surgery
Secondary Outcomes
- Population differences(baseline, day 1, day2, day 3, day 5)
- Post-Operative Syndecan-1 curve(baseline, day 1, day2, day 3, day 5)