Experimental Study of the Vascular Prosthesis Manufactured by Electrospinning
Condition: ARTERIAL OCCLUSIVE DISEASE
MeSH terms: Arterial Occlusive Diseases
Study type: Observational

Summary: 
      The purpose of this study is to determine whether the Vascular prosthesis manufactured by
      Electrospinning is safe with respect to the development of thrombosis.
    

Detailed description: 
      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
    

Intervention name(s): blood sampling procedure
Intervention type(s): Procedure
Intervention description(s): 30 ml of venous blood will be collected from all voluteers using a special vacuum tubes after informed consent. Blood sampling is carried out from an arm vein. All subsequent studies will be executed in the laboratory diagnostic division of Novosibirsk Research Institute of Circulation Pathology and the presence of the donors is unnecessary
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        volunteers, donors
      
Keywords: Haemostas, prosthesis