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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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014