ARTERIAL OCCLUSIVE DISEASE Clinical Trial
Official title:
Evaluate Hemocompatibility Vascular Prosthesis to Prevent Its Thrombosis
The purpose of this study is to determine whether the Vascular prosthesis manufactured by Electrospinning is safe with respect to the development of thrombosis.
To test the influence of the prostheses to hemostasis blood will be pumped through the
vascular prosthesis or control silicone tube (both with identical inner diameter 1,7 mm)
during 20 minutes at a linear velocity 10 cm/sec (corresponding to 18 ml/min). The tested
prostheses (or control tubes) will be installed between two syringes with blood installed in
the UTPS-1 instrument providing synchronical movement of pistons of both syringes. Installing
UTPS-1 was designed and manufactured at the Institute of Chemical Biology and Fundamental
Medicine, Siberian Branch of the Russian Academy of Sciences consists of a mechanical
pushers, equipped with clamps for syringes and pistons, stepper motor, electronic control
unit and power supply.
UTPS-1 and polypropylene non-pyrogenic syringes filled with blood without any bulbs of air
provides absence of contacts with air, pyrogens and minimize lysis of blood cells. UTPS-1 has
no analogues, and does not require licensure, metrological control or obtaining of any other
permits.
After pumping the blood will be separated into plasma and cell fraction according to standard
laboratory methods. Primary blood (before any treatment), blood after pumping through silicon
tube (control), and vascular prosthesis will be tested for hemostatic parameters.
Notification of basic and additional parameters being studied, which will be
evaluated in the study:
1. The initial parameters of blood hemostasis will be evaluated (Platelet count; Platelet
aggregation; Prothrombin time, International Normalised Ratio [INR], activated partial
thromboplastin time (aPTT), prothrombin Quick, thrombin time, soluble fibrin monomer
complexes (SFMC), free hemoglobin and P- selectin concentrations).
2. To evaluate the influence of the prosthesis to circulating blood the same hemostasis
characteristics wiil be evaluated in blood after 20 min of circulation through
prosthesis and silicon tube (Platelet count; Platelet aggregation; Prothrombin time,
International Normalised Ratio [INR], activated partial thromboplastin time (aPTT),
prothrombin Quick, thrombin time, soluble fibrin monomer complexes (SFMC), the
measurement of free hemoglobin, P- selectin).
3. Microscopy: a study of adhesion of blood cells on the surface of the prosthesis
Description of Design of the Research: this will be prospective (are marked in section
Detailed Description)
Monocentred research
Defined indicators for each prosthesis
1. hemostasis characteristics listed hereinabove for untreated blood (control)
2 hemostasis characteristics listed hereinabove in blood after 20 min circulation through
silicone tube (control)
3 hemostasis characteristics listed hereinabove in blood after 20 min circulation through
After the interaction with the experimental vascular prosthesis
Will be studied 4 types of vascular prostheses made by electrospinning
- polycaprolactone;
- polycaprolactone / gelatin/poorly permeable layer;
- polylactide-co-glycolide / polycaprolactone / gelatin/poorly permeable layer;
- nylon 6
;
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