Experimental Study of the Vascular Prosthesis Manufactured by Electrospinning

Study Overview
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Brief Summary
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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
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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: 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). 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). 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

Official Title
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Evaluate Hemocompatibility Vascular Prosthesis to Prevent Its Thrombosis

Conditions
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ARTERIAL OCCLUSIVE DISEASE

Intervention / Treatment
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* Procedure: blood sampling procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged from 18 to 50 years at the date of the informed consent signing; Patients without atherosclerosis Patients without blood pathology Exclusion Criteria: Patient did not sign the informed consent. Early postoperative period. Concomitant diseases such as atherosclerosis, blood pathology, venous thrombosis, malignancy, terminal cancer, infectious - inflammatory disease at the time of the study. Patients after implantation of a cardioverter-defibrillator; prior prosthetic heart valves or other implants, which can lead to mechanical damage to the blood cells. Receiving anticoagulants, antiplatelet, antibacterial drugs, NSAIDs. Myocardial infarction less than 3 months ago. Irreversible failure of major organs with an expected survival time of less than 1 year Pregnancy, lactation. Age above 50 years.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Graft type - PCL<br>PCL - polycaprolactone | Procedure: blood sampling procedure<br>* 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<br>|
| Graft type - PCL/ gelatin<br>polycaprolactone/ gelatin/poorly permeable layer; | Procedure: blood sampling procedure<br>* 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<br>|
| Graft type - PLGA/PCL/gelatin<br>PLGA/PCL/gelatin - polylactide-co-glycolide / polycaprolactone / gelatin/poorly permeable layer | Procedure: blood sampling procedure<br>* 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<br>|
| Graft type - nylon 6<br> | Procedure: blood sampling procedure<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants (blood samples) having a higher degree of aggregation of platelets after interaction with the prosthesis, as a sign of thrombosis. (with ristomycin, adrenaline, collagen, ADP) | percentage | during the day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet count | cells / L | during the day | 
| Prothrombin time | seconds | during the day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Haemostas, prosthesis