Actively Recruiting

Age: 12Years - 75Years
All Genders
ID06119542

Endothelial Glycocalyx Damage in Major Spine Surgery Measured by Circulating Syndecan-1 Levels A Prospective Observational Pilot Study GlycOrtho

Led by Istituto Ortopedico Rizzoli · Updated on 2026-05-22

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating endothelial damage during major spine surgery by measuring the rise of circulating Syndecan-1, a marker of glycocalyx shedding. The study focuses on different surgical groups, including adolescent idiopathic scoliosis, adult degenerative spine disease, and oncologic surgery. This observational pilot study aims to better understand how major spine surgery affects the endothelium, which has been less studied compared to shock conditions like sepsis or trauma. Blood samples will be taken at various times to track changes in Syndecan-1 levels: before surgery, immediately after surgery, before and after any Fresh Frozen Plasma transfusions, and on postoperative days 1, 2, and 4. The study also explores whether Fresh Frozen Plasma transfusions influence endothelial damage, as previous research suggests a possible protective effect. The findings will help guide future clinical trials on how to reduce endothelial injury during surgery. Participants will have blood draws at scheduled times to measure Syndecan-1 changes. Researchers will analyze the amount of endothelial glycocalyx shedding and differences across patient groups and surgical types. The primary outcome is the change in Syndecan-1 levels from baseline to day 1 after surgery. Secondary outcomes include tracking Syndecan-1 levels over several postoperative days and comparing results among different patient populations. The study is expected to conclude by September 2026.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 12Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Undergoing Major Spine Surgery with estimated blood loss greater than 25% of total blood volume
  • American Society of Anesthesiology status 1, 2, or 3
  • Able to comprehend and sign informed consent
  • If under 18 years old, parent or legal representative able to comprehend and sign informed consent
Not Eligible

You will not qualify if you...

  • Surgery scheduled outside of laboratory opening hours
  • Patients undergoing spine surgery for genetic syndromes or neuromuscular scoliosis

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo major spine surgery, during which blood samples are taken to measure Syndecan-1 levels before and immediately after surgery.

1 visit (in-person surgery day)

Post-operative Follow-up

Duration - 5 days after surgery

Participants have blood samples collected on days 1, 2, 3, and 5 after surgery to monitor Syndecan-1 levels and observe endothelial damage over time.

4 visits (in-person on days 1, 2, 3, and 5 post-surgery)

Trial Site Locations

Total: 1 location

1

Sandra Giannone

Bologna, BO, Italy, 40128

Actively Recruiting

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Research Team

S

Sandra Giannone, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Shock induced endotheliopathy (SHINE) in acute critical illness - a unifying pathophysiologic mechanism.

Pär Ingemar Johansson, Jakob Stensballe, Sisse Rye Ostrowski

https://pubmed.ncbi.nlm.nih.gov/28179016

Association between sympathoadrenal activation, fibrinolysis, and endothelial damage in septic patients: a prospective study.

Pär I Johansson, Nicolai Haase, Anders Perner...

https://pubmed.ncbi.nlm.nih.gov/24581948