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

• Conditions: Thrombosis; Thrombus Stability; Thrombus Formation

• Registration Number: NCT01020110
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

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 Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-23
• Study First Submitted QC: 2009-11-23
• Study First Posted: 2009-11-25
• Primary Completion: 2011-09
• Status Verified: 2012-04
• Study Completion: 2012-04
• Last Update Submitted: 2012-04-22
• Last Update Posted: 2012-04-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age > 18 years
• Written informed consent

Exclusion Criteria

• Use of any medication
• Current diseases
• Anemia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
D-Dimer content of the plasmin degraded thrombus	Assessment will follow after all perfusion chamber experiments (1 week)

Trial Locations

Locations (1)

Medical University Vienna- Dept. of Clinical Pharmacology; 🇦🇹 Vienna, Austria