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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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