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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:
To do so, blood samples will be drawn from participants at the following timepoints:
The aim of this study is to gain information about endothelial damage in major spine surgery, expressed as shedding of glycocalyx component Syndecan-1, and subsequent rise of its plasma levels.
This phenomenon has been extensively described in shock states (sepsis, trauma, cardiac arrest ..) but little is known about endothelial damage in elective major surgery.
This study was designed to study the magnitude of Syndecan-1 rise after spine surgery, divided in three main categories: adolescent idiopathic scoliosis, adult degenerative and oncologic surgery.
The investigators were also interested in the effect of Fresh Frozen Plasma transfusion on Syndecan-1 levels, since previous studies have indicated a potential benefit on endothelial integrity.
The results of this study will be used to inform subsequent clinical trials designed to investigate the effect of different intraoperative conducts on endothelial damage.
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| Measure | Description | Time Frame |
|---|---|---|
| Delta Syndecan-1 before -after surgery | Difference between basal Syndecan-1 level and level at the end of surgery | baseline, day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-Operative Syndecan-1 curve | Variation of Syndecan-1 levels at post-operative days 1-2-4 | baseline, day 1, day2, day 3, day 5 |
| Population differences | Difference in baseline and post-operative Syndecan-1 levels in different populations |
| Measure | Description | Time Frame |
|---|---|---|
| Thrombomodulin | Variations of Thrombomodulin levels | baseline, day 1, day2, day 3, day 5 |
| Plasma effect | Difference in Syndecan-1 levels before and after fresh frozen plasma transfusion |
Inclusion Criteria:
Exclusion Criteria:
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This study will take place in patients undergoing major spine surgery.
As a secondary analysis, patients will be divided in three major groups:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandra Giannone, MD | Contact | +393203382071 | sandra.giannone@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sandra Giannone, MD | Istituto Ortopedico Rizzoli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sandra Giannone | Recruiting | Bologna | BO | 40128 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28179016 | Background | 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. | |
| 25082728 | Background | 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. |
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Serum
| baseline, day 1, day2, day 3, day 5 |
| baseline, day 1 |
| 24581948 | Background | 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. |
| 30850020 | Background | 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. |