Study in an Ex-vivo Thrombosis Model With Human Umbilical Vein Endothelial Cells (HUVEC)-Perfusion (HUVEC)
|ClinicalTrials.gov Identifier: NCT01020110|
Recruitment Status : Unknown
Verified April 2012 by Ghazaleh Gouya, Medical University of Vienna.
Recruitment status was: Active, not recruiting
First Posted : November 25, 2009
Last Update Posted : April 24, 2012
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.
|Condition or disease|
|Thrombosis Thrombus Formation Thrombus Stability|
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).
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Observational Model:||Case Control|
|Official Title:||Human Umbilical Vein Endothelial Cells (HUVEC)-Perfusion|
|Study Start Date :||November 2009|
|Primary Completion Date :||September 2011|
|Estimated Study Completion Date :||April 2012|
- D-Dimer content of the plasmin degraded thrombus [ Time Frame: Assessment will follow after all perfusion chamber experiments (1 week) ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01020110
|Medical University Vienna- Dept. of Clinical Pharmacology|
|Vienna, Austria, 1090|
|Principal Investigator:||Michael Wolzt, MD||Medical University Vienna|