Experimental Study of the Vascular Prosthesis Manufactured by Electrospinning

ARTERIAL OCCLUSIVE DISEASE Clinical Trial

Official title:

Evaluate Hemocompatibility Vascular Prosthesis to Prevent Its Thrombosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02255188
• Other study ID #: 16.01.2014 ? 2
• Status: Completed
• Phase: N/A
• First received: September 10, 2014
• Last updated: September 7, 2017
• Start date: October 2014
• Est. completion date: November 2015

Study information

• Verified date: July 2015
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• ARTERIAL OCCLUSIVE DISEASE
• Arterial Occlusive Diseases

Intervention

Procedure:
• blood sampling 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

Locations

Country	Name	City	State
Russian Federation	popova Irina	Novosibirsk	Novosibirskay obl.

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	International Normalised Ratio		during the day
Other	activated partial thromboplastin time	seconds	during the day
Other	prothrombin Quick		during the day
Other	thrombin time	seconds	during the day
Other	soluble fibrin monomer complexes	0-4mg/100ml	during the day
Other	free hemoglobin	g / l	during the day
Other	P- selectin concentrations	ng / ml	during the day
Other	Adhesion of blood cells on the surface of the prosthesis	microscopy	during the day
Primary	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	Platelet count	cells / L	during the day
Secondary	Prothrombin time	seconds	during the day