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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by Ghazaleh Gouya, Medical University of Vienna.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01020110
First Posted: November 25, 2009
Last Update Posted: April 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ghazaleh Gouya, Medical University of Vienna
  Purpose

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.


Condition
Thrombosis Thrombus Formation Thrombus Stability

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Human Umbilical Vein Endothelial Cells (HUVEC)-Perfusion

Resource links provided by NLM:


Further study details as provided by Ghazaleh Gouya, Medical University of Vienna:

Primary Outcome Measures:
  • 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
supernatant of plasmin degraded thrombus including fibrin monomers

Estimated Enrollment: 30
Study Start Date: November 2009
Estimated Study Completion Date: April 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Detailed 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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
30 healthy subjects
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Written informed consent

Exclusion Criteria:

  • Use of any medication
  • Current diseases
  • Anemia
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Austria
Medical University Vienna- Dept. of Clinical Pharmacology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Michael Wolzt, MD Medical University Vienna
  More Information

Responsible Party: Ghazaleh Gouya, Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01020110     History of Changes
Other Study ID Numbers: HUVEC-Version1
First Submitted: November 23, 2009
First Posted: November 25, 2009
Last Update Posted: April 24, 2012
Last Verified: April 2012

Keywords provided by Ghazaleh Gouya, Medical University of Vienna:
perfusion chamber
thrombus D-Dimer
HUVEC

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases