Observing endothelial damage during major spine surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.