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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.
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Graft type - PCL | PCL - polycaprolactone |
| |
| Graft type - PCL/ gelatin | polycaprolactone/ gelatin/poorly permeable layer; |
| |
| Graft type - PLGA/PCL/gelatin | PLGA/PCL/gelatin - polylactide-co-glycolide / polycaprolactone / gelatin/poorly permeable layer |
| |
| Graft type - nylon 6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood sampling procedure | Procedure | 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet count | cells / L | during the day |
| Prothrombin time | seconds | during the day |
| Measure | Description | Time Frame |
|---|---|---|
| International Normalised Ratio | during the day | |
| activated partial thromboplastin time | seconds | during the day |
Inclusion Criteria:
Exclusion Criteria:
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volunteers, donors
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| popova Irina | Novosibirsk | Novosibirskay Obl. | 630055 | Russia |
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| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
| prothrombin Quick |
| during the day |
| thrombin time | seconds | during the day |
| soluble fibrin monomer complexes | 0-4mg/100ml | during the day |
| free hemoglobin | g / l | during the day |
| P- selectin concentrations | ng / ml | during the day |
| Adhesion of blood cells on the surface of the prosthesis | microscopy | during the day |