Endothelial Damage in Major Spine Surgery, Measured by Circulating Syndecan-1: an Observational Study.(GlycOrtho)

ConditionSpinal Fusion
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-75
SponsorIstituto Ortopedico Rizzoli

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Surgery outside of laboratory opening hours

Patients undergoing spine surgery for genetic syndromes/neuromuscular scoliosis

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Delta Syndecan-1 before -after surgery

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

Time frame
baseline, day 1

Secondary outcomes

1

Post-Operative Syndecan-1 curve

Variation of Syndecan-1 levels at post-operative days 1-2-4

Time frame
baseline, day 1, day2, day 3, day 5
2

Population differences

Difference in baseline and post-operative Syndecan-1 levels in different populations

Time frame
baseline, day 1, day2, day 3, day 5

Other outcomes

1

Thrombomodulin

Variations of Thrombomodulin levels

Time frame
baseline, day 1, day2, day 3, day 5
2

Plasma effect

Difference in Syndecan-1 levels before and after fresh frozen plasma transfusion

Time frame
baseline, day 1

Sponsors and contacts

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