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

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

Study Overview

• Status: Recruiting
• Conditions: Spinal Fusion

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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Sandra Giannone, MD; Phone Number: +393203382071; Email: sandra.giannone@gmail.com

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40128
      • Recruiting
      • Sandra Giannone
      • Contact: Sandra Giannone; Email: sandra.giannone@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will take place in patients undergoing major spine surgery.

As a secondary analysis, patients will be divided in three major groups:

• Adolescent idiopathic
• Adult degenerative spine disease
• Cancer surgery

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thrombomodulin	Variations of Thrombomodulin levels	baseline, day 1, day2, day 3, day 5
Plasma effect	Difference in Syndecan-1 levels before and after fresh frozen plasma transfusion	baseline, day 1

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Investigators: Principal Investigator: Sandra Giannone, MD, Istituto Ortopedico Rizzoli

Publications and helpful links

General Publications

• Johansson PI, Stensballe J, Ostrowski SR. Shock induced endotheliopathy (SHINE) in acute critical illness - a unifying pathophysiologic mechanism. Crit Care. 2017 Feb 9;21(1):25. doi: 10.1186/s13054-017-1605-5. Erratum In: Crit Care. 2017 Jul 13;21(1):187.
• Bashandy GM. Implications of recent accumulating knowledge about endothelial glycocalyx on anesthetic management. J Anesth. 2015 Apr;29(2):269-78. doi: 10.1007/s00540-014-1887-6. Epub 2014 Aug 1.
• Johansson PI, Haase N, Perner A, Ostrowski SR. Association between sympathoadrenal activation, fibrinolysis, and endothelial damage in septic patients: a prospective study. J Crit Care. 2014 Jun;29(3):327-33. doi: 10.1016/j.jcrc.2013.10.028. Epub 2014 Jan 28.
• Milford EM, Reade MC. Resuscitation Fluid Choices to Preserve the Endothelial Glycocalyx. Crit Care. 2019 Mar 9;23(1):77. doi: 10.1186/s13054-019-2369-x.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2022
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: November 6, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Surgery; Syndecan-1; Endothelium; Glycocalyx
• Other Study ID Numbers: 1064/2021/Oss/IOR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No