Observing endothelial damage during major spine surgery
Endothelial Glycocalyx Damage in Major Spine Surgery, as Measured by Circulating Syndecan-1 Levels: a Prospective Observational Pilot Study.(GlycOrtho)
Istituto Ortopedico Rizzoli · NCT06119542
This study is trying to see if major spine surgery causes damage to blood vessel lining by checking blood samples from patients before and after their surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 12 Years to 75 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli (other) |
| Locations | 1 site (Bologna, BO) |
| Trial ID | NCT06119542 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate endothelial damage during major spine surgery by measuring the levels of circulating Syndecan-1, a component of the endothelial glycocalyx. Blood samples will be collected from participants at various time points, including before and after surgery, and after Fresh Frozen Plasma transfusions if applicable. The study will categorize participants based on different surgical populations, such as those with adolescent idiopathic scoliosis, adult degenerative spine disease, and oncologic conditions. The findings will help inform future clinical trials focused on mitigating endothelial damage during surgery.
Who should consider this trial
Good fit: Ideal candidates are patients undergoing major spine surgery with an estimated blood loss greater than 25% of total blood volume.
Not a fit: Patients undergoing spine surgery for genetic syndromes or neuromuscular scoliosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of endothelial damage in patients undergoing major spine surgery.
How similar studies have performed: While endothelial damage has been studied in shock states, this specific approach in elective major surgery is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bologna, BO
- Sandra Giannone — Bologna, BO, Italy (RECRUITING)
Study contacts
- Principal investigator: Sandra Giannone, MD — Istituto Ortopedico Rizzoli
- Study coordinator: Sandra Giannone, MD
- Email: sandra.giannone@gmail.com
- Phone: +393203382071
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spinal Fusion, Endothelium, Syndecan-1, Surgery, Glycocalyx