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Effects of Left Ventricular Assist Device Implantation on the Phenotype of Blood Platelets and Leucocytes (DAV-Hémo)

Primary Purpose

Cardiac Insufficiency

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cardiac Insufficiency focused on measuring left ventricular assist device, platelet-leukocyte conjugates, lipo-oxygenase products

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LAVD implantation

Arm Description

Ten patients before and after LAVD implantation had blood sampling

Outcomes

Primary Outcome Measures

Platelet activation
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)

Secondary Outcome Measures

Level of circulating platelet-leukocyte conjugate
To determine the level of circulating platelet-leukocyte conjugate by flow cytometry
Changes in leukocyte phenotype
To determine the leukocyte phenotype which is a composite criteria analysed by flow cytometry, ELISA and lipidaemic analysis

Full Information

First Posted
July 24, 2017
Last Updated
August 19, 2019
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT03306017
Brief Title
Effects of Left Ventricular Assist Device Implantation on the Phenotype of Blood Platelets and Leucocytes
Acronym
DAV-Hémo
Official Title
Study on the Effects of Left Ventricular Assist Device Implantation on the Phenotype of Blood Platelets and Leucocytes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 3, 2017 (Actual)
Primary Completion Date
August 23, 2018 (Actual)
Study Completion Date
January 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To compare in vivo platelet and leukocyte activation and phenotype before and after Left ventricular assist device (LAVD) implantation
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Insufficiency
Keywords
left ventricular assist device, platelet-leukocyte conjugates, lipo-oxygenase products

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LAVD implantation
Arm Type
Experimental
Arm Description
Ten patients before and after LAVD implantation had blood sampling
Intervention Type
Other
Intervention Name(s)
Blood sampling
Intervention Description
Three venous blood sampling before the left ventricular assist device implantation and 1 and 2 months after implantation in ambulatory patients.
Primary Outcome Measure Information:
Title
Platelet activation
Description
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)
Time Frame
Month 2 after LAVD implantation
Secondary Outcome Measure Information:
Title
Level of circulating platelet-leukocyte conjugate
Description
To determine the level of circulating platelet-leukocyte conjugate by flow cytometry
Time Frame
Month 2 after LAVD implantation
Title
Changes in leukocyte phenotype
Description
To determine the leukocyte phenotype which is a composite criteria analysed by flow cytometry, ELISA and lipidaemic analysis
Time Frame
Month 2 after LAVD implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre SIE, MD, PhD
Organizational Affiliation
University Hospital of Toulouse, Rangueil, Hematology laboratory
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital
City
Toulouse
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Left Ventricular Assist Device Implantation on the Phenotype of Blood Platelets and Leucocytes

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