Vascular Graft Storage Solution Preserves Endothelial Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- vessel function organ bath assessment
研究概览
简要总结
Since Saline is still the most widely used storage and flushing solution in cardiovascular procedures despite knowing evidence of its influence on the human endothelial cell function the main aim of this study was to assess the effect of DuraGraft©, an intraoperative graft treatment solution, on human saphenous vein segments 8 Remnants from the operation after trimming the bypass length), rat aortic segments and human umbilical vein endothelial cells (HUVECs) in comparison to saline.
详细描述
Saline is still the most widely used storage and flushing solution in cardiovascular procedures despite knowing evidence of its influence on the human endothelial cell function. Aim of this study was to assess the effect of DuraGraft©, an intraoperative graft treatment solution, on human saphenous vein segments, rat aortic segments and human umbilical vein endothelial cells (HUVECs) in comparison to saline. According to literature saline could have detrimental effects on the endothelium but data shows conflicting evidence. Duragraft a so called endothelial preservation solution should protect the human endothelium. Intent of this observational study was to study the effects of both solutions and compare them.
Within 12 patients undergoing aortocoronary bypass surgery, left overs from saphenous vein graft segments were randomized to DuraGraft© (n=12/6) or saline (n=12/6) solution before intraoperative storage. These segments as well as rat aortic segments underwent assessment of vascular function in a multichamber isometric myograph system in comparison to Krebs-Henseleit solution (KHS), a physiologic organ buffer solution. Additionally, human umbilical vein endothelial cells (HUVECs) were used for cell viability tests.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is undergoing isolated CABG procedure or CABG plus aortic or mitral valve surgery with at least one saphenous vein or radial artery grafts
- •Patient is ≥18 years of age
- •Patient (or a legally authorized representative) is willing and able to provide consent
- •DuraGraft® is being used for the CABG procedure
排除标准
- •Participation in a device study or receiving active drug product in an investigational study within one month (30 days) prior to enrollment.
结局指标
主要结局
vessel function organ bath assessment
时间窗: 3 hours
defines significant contraction or relaxation between the two solutions, a myograph will be used, every change above 5 nM will be seen as significant.
次要结局
- cell viability testing(60 minutes)
研究者
Bernhard Winkler, Associate Professor Priv. Doz. DDR.
Associate Professor MD
Klinikum Floridsdorf