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

This study is ongoing, but not recruiting participants.
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
History of Changes
  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

Further study details as provided by 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) ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ghazaleh Gouya, Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01020110     History of Changes
Other Study ID Numbers: HUVEC-Version1
Study First Received: November 23, 2009
Last Updated: April 22, 2012
Health Authority: Austria: Agency for Health and Food Safety

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

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

ClinicalTrials.gov processed this record on May 16, 2013