- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03306017
Effects of Left Ventricular Assist Device Implantation on the Phenotype of Blood Platelets and Leucocytes (DAV-Hémo)
August 19, 2019 updated by: University Hospital, Toulouse
Study on the Effects of Left Ventricular Assist Device Implantation on the Phenotype of Blood Platelets and Leucocytes
To compare in vivo platelet and leukocyte activation and phenotype before and after Left ventricular assist device (LAVD) implantation
Study Overview
Detailed Description
The present study plan to investigate platelet activation in vivo using a variety of biomarkers previously identified as sensitive to high shear stress in patients with severe aortic valve stenosis before and after trans arterial valve replacement.
As one of the best biomarker is a high degree of platelet-leukocyte interactions, the study will study in parallel leukocytes activation/differentiation.
These parameters will be compared at 3 time-points, before and after LAVD implantation in ambulatory patients.
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Toulouse, France
- University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- elective implantation of LAVD (Heartmate II),
- written informed consent to the study
- Patients with health insurance
Exclusion Criteria:
- treatment or procedure that could affect platelet functions or turn-over(low-dose aspirin is allowed).
- Pregnancy or breastfeeding
- Juridical Protection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LAVD implantation
Ten patients before and after LAVD implantation had blood sampling
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Three venous blood sampling before the left ventricular assist device implantation and 1 and 2 months after implantation in ambulatory patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Platelet activation
Time Frame: Month 2 after LAVD implantation
|
To compare platelet activation in vivo, using a composite criteria determinated by variety of biomarkers of activation analysed by flow cytometry and enzyme-linked immunosorbent assay (ELISA)
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Month 2 after LAVD implantation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of circulating platelet-leukocyte conjugate
Time Frame: Month 2 after LAVD implantation
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To determine the level of circulating platelet-leukocyte conjugate by flow cytometry
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Month 2 after LAVD implantation
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Changes in leukocyte phenotype
Time Frame: Month 2 after LAVD implantation
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To determine the leukocyte phenotype which is a composite criteria analysed by flow cytometry, ELISA and lipidaemic analysis
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Month 2 after LAVD implantation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Pierre SIE, MD, PhD, University Hospital of Toulouse, Rangueil, Hematology laboratory
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 3, 2017
Primary Completion (Actual)
August 23, 2018
Study Completion (Actual)
January 23, 2019
Study Registration Dates
First Submitted
July 24, 2017
First Submitted That Met QC Criteria
October 9, 2017
First Posted (Actual)
October 10, 2017
Study Record Updates
Last Update Posted (Actual)
August 20, 2019
Last Update Submitted That Met QC Criteria
August 19, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/16/8258
- 2016-A01601-50 (Other Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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