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

Cardiac Insufficiency Clinical Trial

— DAV-Hémo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03306017
• Other study ID #: RC31/16/8258
• Secondary ID: 2016-A01601-50
• Status: Completed
• Phase: N/A
• Start date: October 3, 2017
• Est. completion date: January 23, 2019

Study information

• Verified date: August 2019
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: January 23, 2019
• Est. primary completion date: August 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Insufficiency
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
France	University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Month 2 after LAVD implantation
Secondary	Level of circulating platelet-leukocyte conjugate	To determine the level of circulating platelet-leukocyte conjugate by flow cytometry	Month 2 after LAVD implantation
Secondary	Changes in leukocyte phenotype	To determine the leukocyte phenotype which is a composite criteria analysed by flow cytometry, ELISA and lipidaemic analysis	Month 2 after LAVD implantation