Endothelial Damage in Major Spine Surgery, Measured by Circulating Syndecan-1: an Observational Study.(GlycOrtho)
Study Details
Study Description
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:
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What is the extent of endothelial glycocalyx shedding in major spine surgery?
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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:
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basal
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after surgery
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if transfusion of Fresh Frozen Plasma: before and after transfusion
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Post-Operative Day 1-2-4
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Delta Syndecan-1 before -after surgery [baseline, day 1]
Difference between basal Syndecan-1 level and level at the end of surgery
Secondary Outcome Measures
- Post-Operative Syndecan-1 curve [baseline, day 1, day2, day 3, day 5]
Variation of Syndecan-1 levels at post-operative days 1-2-4
- Population differences [baseline, day 1, day2, day 3, day 5]
Difference in baseline and post-operative Syndecan-1 levels in different populations
Other Outcome Measures
- Thrombomodulin [baseline, day 1, day2, day 3, day 5]
Variations of Thrombomodulin levels
- Plasma effect [baseline, day 1]
Difference in Syndecan-1 levels before and after fresh frozen plasma transfusion
Eligibility Criteria
Criteria
Inclusion Criteria:
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Undergoing Major Spine Surgery with estimated blood loss> 25% of total blood volume
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American Society of Anesthesiology status 1-2-3
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Able to comprehend and sign informed consent.
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If age <18 years: parent or legal representative able to comprehend and sign informed consent
Exclusion Criteria:
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Surgery outside of laboratory opening hours
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Patients undergoing spine surgery for genetic syndromes/neuromuscular scoliosis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sandra Giannone | Bologna | BO | Italy | 40128 |
Sponsors and Collaborators
- Istituto Ortopedico Rizzoli
Investigators
- Principal Investigator: Sandra Giannone, MD, Istituto Ortopedico Rizzoli
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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. Erratum In: Crit Care. 2017 Jul 13;21(1):187.
- 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.
- 1064/2021/Oss/IOR