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NCT Number: NCT06119542

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

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

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Key information

Conditions

Spinal Fusion

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sandra Giannone

Bologna, BO, 40128, Italy

Location status: Recruiting

Location contact

Sandra Giannone

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Post-Operative Syndecan-1 curve

    Time frame: baseline, day 1, day2, day 3, day 5

    Variation of Syndecan-1 levels at post-operative days 1-2-4

  2. Population differences

    Time frame: baseline, day 1, day2, day 3, day 5

    Difference in baseline and post-operative Syndecan-1 levels in different populations

Other outcomes

  1. Thrombomodulin

    Time frame: baseline, day 1, day2, day 3, day 5

    Variations of Thrombomodulin levels

  2. Plasma effect

    Time frame: baseline, day 1

    Difference in Syndecan-1 levels before and after fresh frozen plasma transfusion

Study contacts

Contact information is provided by the study sponsor or research team.

Sandra Giannone, MD

CONTACT

[email protected]

+393203382071

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Acronym: GlycOrtho

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 7, 2023
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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