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

Spinal Fusion Clinical Trial

— GlycOrtho  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06119542
• Other study ID #: 1064/2021/Oss/IOR
• Status: Recruiting
• Start date: February 28, 2022
• Est. completion date: February 28, 2025

Study information

• Verified date: November 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: Sandra Giannone, MD
• Phone: +393203382071
• Email: sandra.giannone[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 28, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Fusion

Locations

Country	Name	City	State
Italy	Sandra Giannone	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Thrombomodulin	Variations of Thrombomodulin levels	baseline, day 1, day2, day 3, day 5
Other	Plasma effect	Difference in Syndecan-1 levels before and after fresh frozen plasma transfusion	baseline, day 1
Primary	Delta Syndecan-1 before -after surgery	Difference between basal Syndecan-1 level and level at the end of surgery	baseline, day 1
Secondary	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
Secondary	Population differences	Difference in baseline and post-operative Syndecan-1 levels in different populations	baseline, day 1, day2, day 3, day 5