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RECRUITINGNCT06119542

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...

Lead sponsor: Istituto Ortopedico Rizzoli•1 locations•View source on ClinicalTrials.gov

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Contacts

Sandra Giannone, MD

CONTACT

+393203382071 sandra.giannone@gmail.com

Sponsors

Lead Sponsor

Istituto Ortopedico Rizzoli

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.

Age

12 - 75 years

Sex

ALL

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: November 13, 2024Terms

Trial snapshot

StatusRECRUITING

Phase—

Enrollment30

Start dateFeb 2022

Last updatedNov 13, 2024

Condition

Locations shown

Sandra Giannone

Bologna, BO

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 13, 2024Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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