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

April 22, 2012 updated by: Ghazaleh Gouya, Medical University of Vienna

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.

Study Overview

Status

Unknown

Conditions

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).

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University Vienna- Dept. of Clinical Pharmacology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

30 healthy subjects

Description

Inclusion Criteria:

  • Age > 18 years
  • Written informed consent

Exclusion Criteria:

  • Use of any medication
  • Current diseases
  • Anemia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Michael Wolzt, MD, Medical University Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Anticipated)

April 1, 2012

Study Registration Dates

First Submitted

November 23, 2009

First Submitted That Met QC Criteria

November 23, 2009

First Posted (Estimate)

November 25, 2009

Study Record Updates

Last Update Posted (Estimate)

April 24, 2012

Last Update Submitted That Met QC Criteria

April 22, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUVEC-Version1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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