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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06119542

Acronym

GlycOrtho

Enrollment

Registered

2023-11-07

Start date

2026-02-28

Completion date

2026-09-30

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Fusion

Keywords

Endothelium, Syndecan-1, Surgery, Glycocalyx

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Contacts

CONTACTSandra Giannone, MD

sandra.giannone@gmail.com+393203382071

PRINCIPAL_INVESTIGATORSandra Giannone, MD

Istituto Ortopedico Rizzoli

Outcome results