Overview

This trial is active, not recruiting.

Conditions thrombosis, thrombus formation, thrombus stability
Sponsor Medical University of Vienna
Start date November 2009
End date September 2011
Trial size 30 participants
Trial identifier NCT01020110, HUVEC-Version1

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective

Primary Outcomes

Measure
D-Dimer content of the plasmin degraded thrombus
time frame: Assessment will follow after all perfusion chamber experiments (1 week)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Age > 18 years - Written informed consent Exclusion Criteria: - Use of any medication - Current diseases - Anemia

Additional Information

Official title Human Umbilical Vein Endothelial Cells (HUVEC)-Perfusion
Principal investigator Michael Wolzt, MD
Description 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).
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by Medical University of Vienna.