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Completed

NCT Number: NCT03306017

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

Completed

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Key information

Conditions

Cardiac Insufficiency Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Toulouse, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Other

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Level of circulating platelet-leukocyte conjugate

    Time frame: Month 2 after LAVD implantation

    To determine the level of circulating platelet-leukocyte conjugate by flow cytometry

  2. Changes in leukocyte phenotype

    Time frame: Month 2 after LAVD implantation

    To determine the leukocyte phenotype which is a composite criteria analysed by flow cytometry, ELISA and lipidaemic analysis

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: DAV-Hémo

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Oct 10, 2017
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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