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临床试验/NCT01020110
NCT01020110Unknown不适用

Human Umbilical Vein Endothelial Cells (HUVEC)-Perfusion

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
D-Dimer content of the plasmin degraded thrombus

研究概览

简要总结

Evaluation of fibrin and platelet deposition on a human umbilical endothelial cell surface in perfusion chamber experiments using human whole blood.

Open-label, non interventional study Perfusion chamber experiment will be performed in 30 healthy patients. The Impact of different pH-solutions on thrombus lysis will be evaluated in an in-vitro second step

Outcome:

D-Dimer content of the thrombus reflecting the size of the thrombus.

详细描述

All Subjects will have two perfusion chamber experiment as follow with an estimated maximum of blood loss of 165ml:

Before blood perfusion, perfuse the system including the chambers with human umbilical vein endothelial cell coated glass slides (HUVEC), with sodium chloride (NaCl) (0.9%), to ensure no leaks and to remove all air bubbles.

Blood is drawn from a vein in the arm with a Surflo® Winged Infusion Set, 19G (Terumo Europe, Leuven, Belgium) with a pump (Masterflex® L/S™, Cole-Parmer Instrument Company, Vernon Hills, Illinois, USA). Five mL of blood is discarded before each perfusion.

Three in serial placed flow chambers (with HUVEC) heated to 37°C are used. They are made of a Plexiglas block through which a cylindrical hole of 0.2 cm in diameter is machined. The aorta pieces are perfused at 10 mL/min for 5 minutes, followed by a 30 seconds perfusion with NaCl (0.9%).

The plasmin degraded thrombus D-Dimer content will be further evaluated under different conditions (different pH solutions).

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years
  • Written informed consent

排除标准

  • Use of any medication
  • Current diseases

结局指标

主要结局

D-Dimer content of the plasmin degraded thrombus

时间窗: Assessment will follow after all perfusion chamber experiments (1 week)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ghazaleh Gouya

Dr.

Medical University of Vienna

研究点 (1)

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