Spinal FusionGlycOrthoNCT06119542
Endothelial Damage in Major Spine Surgery, Measured by Circulating Syndecan-1: an Observational Study.(GlycOrtho)
An observational study of Spinal Fusion, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Spinal Fusion
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 28 Feb 2026to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Surgery outside of laboratory opening hours
- Patients undergoing spine surgery for genetic syndromes/neuromuscular scoliosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Sandra Giannone
Bologna, BO, 40128
Sandra Giannone, sandra.giannone@gmail.com
About this study
Official title: 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
Read the 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.
- Conditions
- Spinal Fusion
- Keywords
- Endothelium, Syndecan-1, Surgery, Glycocalyx
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta Syndecan-1 before -after surgery
Difference between basal Syndecan-1 level and level at the end of surgery
Measured: baseline, day 1
Secondary outcomes (2)
Post-Operative Syndecan-1 curve
Variation of Syndecan-1 levels at post-operative days 1-2-4
Measured: baseline, day 1, day2, day 3, day 5
Population differences
Difference in baseline and post-operative Syndecan-1 levels in different populations
Measured: baseline, day 1, day2, day 3, day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start28 Feb 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spinal FusionStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra Giannone, MD, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119542
- Sponsor's protocol ID
- 1064/2021/Oss/IOR
- Acronym
- GlycOrtho
- Status last verified
- May 2026
- First submitted
- 25 Oct 2023
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 28179016Bashandy 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.
PubMed 25082728Johansson 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.
PubMed 24581948Milford 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.
PubMed 30850020
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Glycocalyx Damage in Major Spine Surgery, as Measured by Circulating Syndecan-1 Levels: a Prospective Observational Pilot Study.(GlycOrtho)
- ClinicalTrials.gov ID
- NCT06119542
- Acronym / sponsor ID
- GlycOrtho / 1064/2021/Oss/IOR
- Conditions
- Spinal Fusion
- Keywords
- Endothelium, Syndecan-1, Surgery, Glycocalyx
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Surgery outside of laboratory opening hours
- Patients undergoing spine surgery for genetic syndromes/neuromuscular scoliosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Delta Syndecan-1 before -after surgery
Time frame: baseline, day 1
Difference between basal Syndecan-1 level and level at the end of surgery
2 secondary outcomes
Post-Operative Syndecan-1 curve
Time frame: baseline, day 1, day2, day 3, day 5
Population differences
Time frame: baseline, day 1, day2, day 3, day 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 28179016Johansson 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.
- Background: PubMed 25082728Bashandy 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.
- Background: PubMed 24581948Johansson 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.
- Background: PubMed 30850020Milford 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sandra Giannone, MD principal investigator
Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Fusion, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra Giannone, MD (+393203382071, sandra.giannone@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delta Syndecan-1 before -after surgery (time frame: baseline, day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06119542, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.