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CompletedNCT03306017DAV-HémoUpdated Aug 20, 2019

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

An interventional study of Blood sampling in Cardiac Insufficiency, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-20.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cardiac Insufficiency

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Keywords

  • left ventricular assist device
  • platelet-leukocyte conjugates
  • lipo-oxygenase products
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • elective implantation of LAVD (Heartmate II),
  • written informed consent to the study
  • Patients with health insurance

Exclusion criteria

Exclusion Criteria:

  • treatment or procedure that could affect platelet functions or turn-over(low-dose aspirin is allowed).
  • Pregnancy or breastfeeding
  • Juridical Protection
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    LAVD implantation

    Ten patients before and after LAVD implantation had blood sampling

    Other: Blood sampling

Interventions

  • OtherBlood sampling

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

05

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Month 2 after LAVD implantation

Secondary outcomes

  1. Level of circulating platelet-leukocyte conjugate

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

    Time frame: Month 2 after LAVD implantation

  2. Changes in leukocyte phenotype

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

    Time frame: Month 2 after LAVD implantation

06

Study locations

1 site
  • University Hospital
    Toulouse, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03306017
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Oct 10, 2017
Start date
Oct 3, 2017
Primary completion
Aug 23, 2018
Completion
Jan 23, 2019
Last update
Aug 20, 2019

Study contacts

Pierre SIE, MD, PhD
study chair · University Hospital of Toulouse, Rangueil, Hematology laboratory

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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