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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03306017

Acronym

DAV-Hémo

Enrollment

Registered

2017-10-10

Start date

2017-10-03

Completion date

2019-01-23

Last updated

2019-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Insufficiency

Keywords

left ventricular assist device, platelet-leukocyte conjugates, lipo-oxygenase products

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.

Interventions

OTHERBlood sampling

Three venous blood sampling before the left ventricular assist device implantation and 1 and 2 months after implantation in ambulatory patients.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Level of circulating platelet-leukocyte conjugate	Month 2 after LAVD implantation	To determine the level of circulating platelet-leukocyte conjugate by flow cytometry
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026