Study in an Ex-vivo Thrombosis Model With Human Umbilical Vein Endothelial Cells (HUVEC)-Perfusion (HUVEC)
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|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|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|