Experimental Study of the Vascular Prosthesis Manufactured by Electrospinning
Evaluate Hemocompatibility Vascular Prosthesis to Prevent Its Thrombosis
1 other identifier
observational
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedFirst Posted
Study publicly available on registry
October 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedSeptember 8, 2017
July 1, 2015
1 year
September 10, 2014
September 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Platelet count
during the day
Prothrombin time
during the day
Other Outcomes (8)
International Normalised Ratio
during the day
activated partial thromboplastin time
during the day
prothrombin Quick
during the day
- +5 more other outcomes
Study Arms (4)
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
Interventions
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
Eligibility Criteria
volunteers, donors
You may qualify if:
- Male or female aged from 18 to 50 years at the date of the informed consent signing;
- Patients without atherosclerosis
- Patients without blood pathology
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
popova Irina
Novosibirsk, Novosibirskay Obl., 630055, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2014
First Posted
October 2, 2014
Study Start
October 1, 2014
Primary Completion
October 1, 2015
Study Completion
November 1, 2015
Last Updated
September 8, 2017
Record last verified: 2015-07