ARTERIAL OCCLUSIVE DISEASENCT02255188
Experimental Study of the Vascular Prosthesis Manufactured by Electrospinning
An observational study of ARTERIAL OCCLUSIVE DISEASE, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- ARTERIAL OCCLUSIVE DISEASE
- What is being tested?
- blood sampling procedure
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- Oct 2014to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: volunteers, donors
Who may be able to join
- Male or female aged from 18 to 50 years at the date of the informed consent signing;
- Patients without atherosclerosis
- Patients without blood pathology
Who cannot join
- 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.
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- Irreversible failure of major organs with an expected survival time of less than 1 year
- Pregnancy, lactation.
- Age above 50 years.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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
- 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
- Conditions
- ARTERIAL OCCLUSIVE DISEASE
- Being tested
- blood sampling procedure
- Keywords
- Haemostas, prosthesis
- Medical subject headings
- Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampling procedureProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Graft type - PCL | PCL - polycaprolactone Receives: Procedure: blood sampling procedure | |
| Graft type - PCL/ gelatin | polycaprolactone/ gelatin/poorly permeable layer; Receives: Procedure: blood sampling procedure | |
| Graft type - PLGA/PCL/gelatin | PLGA/PCL/gelatin - polylactide-co-glycolide / polycaprolactone / gelatin/poorly permeable layer Receives: Procedure: blood sampling procedure | |
| Graft type - nylon 6 | Not described Receives: Procedure: blood sampling procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during the day
Secondary outcomes (2)
Platelet count
cells / L
Measured: during the day
Prothrombin time
seconds
Measured: during the day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARTERIAL OCCLUSIVE DISEASEStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255188
- Sponsor's protocol ID
- 16.01.2014 № 2
- Status last verified
- Jul 2015
- First submitted
- 10 Sep 2014
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate Hemocompatibility Vascular Prosthesis to Prevent Its Thrombosis
- ClinicalTrials.gov ID
- NCT02255188
- Acronym / sponsor ID
- 16.01.2014 № 2
- Conditions
- ARTERIAL OCCLUSIVE DISEASE
- Keywords
- Haemostas, prosthesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 2 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Graft type - PCL | – | Procedure: blood sampling procedurePCL - polycaprolactone |
| Graft type - PCL/ gelatin | – | Procedure: blood sampling procedurepolycaprolactone/ gelatin/poorly permeable layer; |
| Graft type - PLGA/PCL/gelatin | – | Procedure: blood sampling procedurePLGA/PCL/gelatin - polylactide-co-glycolide / polycaprolactone / gelatin/poorly permeable layer |
| Graft type - nylon 6 | – | Procedure: blood sampling procedure |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- volunteers, donors
Key inclusion criteria (3 listed)
- Male or female aged from 18 to 50 years at the date of the informed consent signing;
- Patients without atherosclerosis
- Patients without blood pathology
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampling procedure30 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 | Procedure or surgery | Graft type - PCL, Graft type - PCL/ gelatin, Graft type - PLGA/PCL/gelatin, Graft type - nylon 6 |
Primary outcome
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)
Time frame: during the day
percentage
2 secondary outcomes
Platelet count
Time frame: during the day
Prothrombin time
Time frame: during the day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARTERIAL OCCLUSIVE DISEASE, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: during the day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2017.