Study in an Ex-vivo Thrombosis Model With Human Umbilical Vein Endothelial Cells (HUVEC)-Perfusion

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Medical University of Vienna.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Ghazaleh Gouya, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01020110
First received: November 23, 2009
Last updated: April 22, 2012
Last verified: April 2012

November 23, 2009
April 22, 2012
November 2009
September 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01020110 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Study in an Ex-vivo Thrombosis Model With Human Umbilical Vein Endothelial Cells (HUVEC)-Perfusion
Human Umbilical Vein Endothelial Cells (HUVEC)-Perfusion

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.

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).

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

supernatant of plasmin degraded thrombus including fibrin monomers

Non-Probability Sample

30 healthy subjects

  • Thrombosis
  • Thrombus Formation
  • Thrombus Stability
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
April 2012
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18 years
  • Written informed consent

Exclusion Criteria:

  • Use of any medication
  • Current diseases
  • Anemia
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01020110
HUVEC-Version1
No
Ghazaleh Gouya, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Michael Wolzt, MD Medical University Vienna
Medical University of Vienna
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP