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Clinical Trials/NCT03306017
NCT03306017
Completed
N/A

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

University Hospital, Toulouse1 site in 1 country4 target enrollmentOctober 3, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cardiac Insufficiency
Sponsor
University Hospital, Toulouse
Enrollment
4
Locations
1
Primary Endpoint
Platelet activation
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 3, 2017
End Date
January 23, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

  • Changes in leukocyte phenotype(Month 2 after LAVD implantation)
  • Level of circulating platelet-leukocyte conjugate(Month 2 after LAVD implantation)

Study Sites (1)

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