NCT06119542 Endothelial Damage in Major Spine Surgery, Measured by Circulating Syndecan-1: an Observational Study.(GlycOrtho)
| NCT ID | NCT06119542 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Spinal Fusion |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-02-28 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2026-02-28 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Sandra Giannone, MD
PRINCIPAL INVESTIGATOR
Istituto Ortopedico Rizzoli
Frequently Asked Questions
Who can join the NCT06119542 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 75 Years, studying Spinal Fusion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06119542 currently recruiting?
Yes, NCT06119542 is actively recruiting participants. Contact the research team at sandra.giannone@gmail.com for enrollment information.
Where is the NCT06119542 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06119542 clinical trial?
NCT06119542 is sponsored by Istituto Ortopedico Rizzoli. The principal investigator is Sandra Giannone, MD at Istituto Ortopedico Rizzoli. The trial plans to enroll 30 participants.