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

Not Applicable

Completed

• Conditions: Cardiac Insufficiency
• Interventions: Other: Blood sampling

• Registration Number: NCT03306017
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study First Submitted: 2017-07-24
• Study Start: 2017-10-03
• Study First Submitted QC: 2017-10-09
• Study First Posted: 2017-10-10
• Primary Completion: 2018-08-23
• Study Completion: 2019-01-23
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LAVD implantation	Blood sampling	Ten patients before and after LAVD implantation had blood sampling

Primary Outcome Measures

Name	Time	Method
Platelet activation	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)

Secondary Outcome Measures

Name	Time	Method
Changes in leukocyte phenotype	Month 2 after LAVD implantation	To determine the leukocyte phenotype which is a composite criteria analysed by flow cytometry, ELISA and lipidaemic analysis
Level of circulating platelet-leukocyte conjugate	Month 2 after LAVD implantation	To determine the level of circulating platelet-leukocyte conjugate by flow cytometry

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Toulouse, France