<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03306017</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/16/8258</org_study_id>
    <secondary_id>2016-A01601-50</secondary_id>
    <nct_id>NCT03306017</nct_id>
  </id_info>
  <brief_title>Effects of Left Ventricular Assist Device Implantation on the Phenotype of Blood Platelets and Leucocytes</brief_title>
  <acronym>DAV-Hémo</acronym>
  <official_title>Study on the Effects of Left Ventricular Assist Device Implantation on the Phenotype of Blood Platelets and Leucocytes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare in vivo platelet and leukocyte activation and phenotype before and after Left&#xD;
      ventricular assist device (LAVD) implantation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study plan to investigate platelet activation in vivo using a variety of&#xD;
      biomarkers previously identified as sensitive to high shear stress in patients with severe&#xD;
      aortic valve stenosis before and after trans arterial valve replacement. As one of the best&#xD;
      biomarker is a high degree of platelet-leukocyte interactions, the study will study in&#xD;
      parallel leukocytes activation/differentiation. These parameters will be compared at 3&#xD;
      time-points, before and after LAVD implantation in ambulatory patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 3, 2017</start_date>
  <completion_date type="Actual">January 23, 2019</completion_date>
  <primary_completion_date type="Actual">August 23, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Platelet activation</measure>
    <time_frame>Month 2 after LAVD implantation</time_frame>
    <description>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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Level of circulating platelet-leukocyte conjugate</measure>
    <time_frame>Month 2 after LAVD implantation</time_frame>
    <description>To determine the level of circulating platelet-leukocyte conjugate by flow cytometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in leukocyte phenotype</measure>
    <time_frame>Month 2 after LAVD implantation</time_frame>
    <description>To determine the leukocyte phenotype which is a composite criteria analysed by flow cytometry, ELISA and lipidaemic analysis</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Cardiac Insufficiency</condition>
  <arm_group>
    <arm_group_label>LAVD implantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ten patients before and after LAVD implantation had blood sampling</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood sampling</intervention_name>
    <description>Three venous blood sampling before the left ventricular assist device implantation and 1 and 2 months after implantation in ambulatory patients.</description>
    <arm_group_label>LAVD implantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective implantation of LAVD (Heartmate II),&#xD;
&#xD;
          -  written informed consent to the study&#xD;
&#xD;
          -  Patients with health insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  treatment or procedure that could affect platelet functions or turn-over(low-dose&#xD;
             aspirin is allowed).&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Juridical Protection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pierre SIE, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital of Toulouse, Rangueil, Hematology laboratory</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>October 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>August 19, 2019</last_update_submitted>
  <last_update_submitted_qc>August 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>left ventricular assist device</keyword>
  <keyword>platelet-leukocyte conjugates</keyword>
  <keyword>lipo-oxygenase products</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03306017
org study id: RC31/16/8258
secondary id: 2016-A01601-50
nct id: NCT03306017
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To compare in vivo platelet and leukocyte activation and phenotype before and after Left
      ventricular assist device (LAVD) implantation
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Platelet activation
time frame: Month 2 after LAVD implantation
description: 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)
measure: Level of circulating platelet-leukocyte conjugate
time frame: Month 2 after LAVD implantation
description: To determine the level of circulating platelet-leukocyte conjugate by flow cytometry
measure: Changes in leukocyte phenotype
time frame: Month 2 after LAVD implantation
description: To determine the leukocyte phenotype which is a composite criteria analysed by flow cytometry, ELISA and lipidaemic analysis
arm group label: LAVD implantation
arm group type: Experimental
description: Ten patients before and after LAVD implantation had blood sampling
intervention type: Other
intervention name: Blood sampling
description: Three venous blood sampling before the left ventricular assist device implantation and 1 and 2 months after implantation in ambulatory patients.
arm group label: LAVD implantation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pierre SIE, MD, PhD
role: Study Chair
affiliation: University Hospital of Toulouse, Rangueil, Hematology laboratory
facility: 
country: France
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No