Study on the Effects of Left Ventricular Assist Device Implantation on the Phenotype of Blood Platelets and Leucocytes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Platelet activation
研究概览
简要总结
To compare in vivo platelet and leukocyte activation and phenotype before and after Left ventricular assist device (LAVD) implantation
详细描述
The present study plan to investigate platelet activation in vivo using a variety of biomarkers previously identified as sensitive to high shear stress in patients with severe aortic valve stenosis before and after trans arterial valve replacement. As one of the best biomarker is a high degree of platelet-leukocyte interactions, the study will study in parallel leukocytes activation/differentiation. These parameters will be compared at 3 time-points, before and after LAVD implantation in ambulatory patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective implantation of LAVD (Heartmate II),
- •written informed consent to the study
- •Patients with health insurance
排除标准
- •treatment or procedure that could affect platelet functions or turn-over(low-dose aspirin is allowed).
- •Pregnancy or breastfeeding
- •Juridical Protection
研究组 & 干预措施
LAVD implantation
Ten patients before and after LAVD implantation had blood sampling
干预措施: Blood sampling (Other)
结局指标
主要结局
Platelet activation
时间窗: Month 2 after LAVD implantation
To compare platelet activation in vivo, using a composite criteria determinated by variety of biomarkers of activation analysed by flow cytometry and enzyme-linked immunosorbent assay (ELISA)
次要结局
- Changes in leukocyte phenotype(Month 2 after LAVD implantation)
- Level of circulating platelet-leukocyte conjugate(Month 2 after LAVD implantation)