Study in an Ex-vivo Thrombosis Model With Human Umbilical Vein Endothelial Cells (HUVEC)-Perfusion
Recruitment status was Active, not recruiting
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
D-Dimer content of the thrombus reflecting the size of the thrombus.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Human Umbilical Vein Endothelial Cells (HUVEC)-Perfusion|
- D-Dimer content of the plasmin degraded thrombus [ Time Frame: Assessment will follow after all perfusion chamber experiments (1 week) ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
supernatant of plasmin degraded thrombus including fibrin monomers
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||April 2012|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020110
|Medical University Vienna- Dept. of Clinical Pharmacology|
|Vienna, Austria, 1090|
|Principal Investigator:||Michael Wolzt, MD||Medical University Vienna|