Endothelial Glycocalyx Damage in Major Spine Surgery, as Measured by Circulating Syndecan-1 Levels: a Prospective Observational Pilot Study.(GlycOrtho)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Delta Syndecan-1 before -after surgery
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Surgery outside of laboratory opening hours
- •Patients undergoing spine surgery for genetic syndromes/neuromuscular scoliosis
结局指标
主要结局
Delta Syndecan-1 before -after surgery
时间窗: baseline, day 1
Difference between basal Syndecan-1 level and level at the end of surgery
次要结局
- Population differences(baseline, day 1, day2, day 3, day 5)
- Post-Operative Syndecan-1 curve(baseline, day 1, day2, day 3, day 5)