NCT06119542

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
2mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Feb 2026Sep 2026

First Submitted

Initial submission to the registry

October 25, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
2.3 years until next milestone

Study Start

First participant enrolled

February 28, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

October 25, 2023

Last Update Submit

May 20, 2026

Conditions

Spinal Fusion

Keywords

EndotheliumSyndecan-1SurgeryGlycocalyx

Outcome Measures

Primary Outcomes (1)

  • Delta Syndecan-1 before -after surgery

    Difference between basal Syndecan-1 level and level at the end of surgery

    baseline, day 1

Secondary Outcomes (2)

  • Post-Operative Syndecan-1 curve

    baseline, day 1, day2, day 3, day 5

  • Population differences

    baseline, day 1, day2, day 3, day 5

Other Outcomes (2)

  • Thrombomodulin

    baseline, day 1, day2, day 3, day 5

  • Plasma effect

    baseline, day 1

Eligibility Criteria

Age12 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Surgery outside of laboratory opening hours
  • Patients undergoing spine surgery for genetic syndromes/neuromuscular scoliosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sandra Giannone

Bologna, BO, 40128, Italy

RECRUITING

Related Publications (4)

  • 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.

    PMID: 28179016BACKGROUND

  • 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.

    PMID: 25082728BACKGROUND

  • 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.

    PMID: 24581948BACKGROUND

  • 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.

    PMID: 30850020BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

Study Officials

  • Sandra Giannone, MD

    Istituto Ortopedico Rizzoli

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra Giannone, MD

CONTACT

+393203382071sandra.giannone@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2023

First Posted

November 7, 2023

Study Start

February 28, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations

IT(1)