Clinical trial NCT06119542: Endothelial Damage in Major Spine Surgery, Measured by Circulating Syndecan-1: an Observational Study.(GlycOrtho)
Official title: Endothelial Glycocalyx Damage in Major Spine Surgery, as Measured by Circulating Syndecan-1 Levels: a Prospective Observational Pilot Study.(GlycOrtho)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Fusion
Keywords: Endothelium
Syndecan-1
Surgery
Glycocalyx
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Delta Syndecan-1 before -after surgery
timeFrame: baseline, day 1
Secondary outcomes:
measure: Post-Operative Syndecan-1 curve
timeFrame: baseline, day 1, day2, day 3, day 5
measure: Population differences
timeFrame: baseline, day 1, day2, day 3, day 5
Other outcomes:
measure: Thrombomodulin
timeFrame: baseline, day 1, day2, day 3, day 5
measure: Plasma effect
timeFrame: baseline, day 1
Locations:
city: Bologna
country: Italy
facility: Sandra Giannone
state: BO
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Sandra Giannone, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.