<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/NCT03773159</url>
  </required_header>
  <id_info>
    <org_study_id>De MAISTRE ANR 2017</org_study_id>
    <nct_id>NCT03773159</nct_id>
  </id_info>
  <brief_title>Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions</brief_title>
  <acronym>INDONESIA</acronym>
  <official_title>Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Currently, the exploration of primary hemostasis (a physiological phenomenon used to stop&#xD;
      bleeding) is imperfect because it is based on targeted tests for platelets or von Willebrand&#xD;
      factor, without taking into account blood flow and other blood cells (red and white blood&#xD;
      cells). Tests for whole blood and flow conditions exist, but there is currently no test that&#xD;
      comes close to actual physiological conditions.&#xD;
&#xD;
      An exploration of whole blood haemostasis in a device that is similar to a blood vessel and&#xD;
      at different flow conditions (venous and arterial) could help to better identify the risk of&#xD;
      bleeding in predisposed patients (von Willebrand factor deficiency, antiplatelet therapy).&#xD;
&#xD;
      The objective of the study is to evaluate the performance of this new hemostasis test in&#xD;
      whole blood and under flow conditions.&#xD;
&#xD;
      Participation in the study is ad hoc and is limited to adding a maximum of 4 citrated tubes&#xD;
      (20 mL or the equivalent of 4 teaspoons) and 1 EDTA tube (5mL) to a routine blood sample (for&#xD;
      patients) or during blood donation (for controls).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 6, 2019</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Anticipated">May 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Repeatability and reproducibility of the result in controls</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Detection of antiplatelet or von Willebrand factor deficiency/major constitutional thrombopathy</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Von Willebrand Diseases</condition>
  <condition>Major Constitutional Thrombopathy</condition>
  <condition>Patient on Antiplatelet Drugs</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>Patients with von Willebrand disease or major constitutional thrombopathy or patients on antiplatelet drugs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Blood donors at the French blood establishment in Burgundy Franche-Comté</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood sampling</intervention_name>
    <description>4 citrated/PPACK tubes and 1 EDTA tube maximum</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with von Willebrand disease or major constitutional thrombopathy or patient on&#xD;
        antiplatelet drugs&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  person who has given oral consent&#xD;
&#xD;
          -  adult&#xD;
&#xD;
          -  blood donor at EFS Bourgogne Franche-Comté&#xD;
&#xD;
          -  or patient with von Willebrand disease or major constitutional thrombopathy followed&#xD;
             by the Resource and Competence Centre (CRC) - Constitutional Hemorrhagic Diseases of&#xD;
             Dijon or Besançon&#xD;
&#xD;
          -  or patient on antiplatelet drugs consulting for thrombosis at the Dijon Bourgogne or&#xD;
             Besançon Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a person who is not affiliated to or not a beneficiary of national health insurance&#xD;
&#xD;
          -  person subject to court-ordered protection (curatorship, guardianship)&#xD;
&#xD;
          -  pregnant, parturient or breastfeeding woman&#xD;
&#xD;
          -  a person who is unable to consent&#xD;
&#xD;
          -  person on anti-inflammatory treatment and serotonin reuptake inhibitor antidepressants&#xD;
             (platelet function disorders)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Emmanuel De Maistre</last_name>
    <phone>03 81 61 56 15</phone>
    <email>emmanuel.demaistre@chu-dijon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Besançon</name>
      <address>
        <city>Besançon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guillaume MOUREY</last_name>
      <phone>03 81 61 56 15</phone>
      <email>guillaume.mourey@efs.sante.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emmanuel De Maistre</last_name>
      <phone>03 80 29 32 57</phone>
      <email>emmanuel.demaistre@chu-dijon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>May 2, 2022</last_update_submitted>
  <last_update_submitted_qc>May 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Von Willebrand Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT03773159
org study id: De MAISTRE ANR 2017
nct id: NCT03773159
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Currently, the exploration of primary hemostasis (a physiological phenomenon used to stop
      bleeding) is imperfect because it is based on targeted tests for platelets or von Willebrand
      factor, without taking into account blood flow and other blood cells (red and white blood
      cells). Tests for whole blood and flow conditions exist, but there is currently no test that
      comes close to actual physiological conditions.

      An exploration of whole blood haemostasis in a device that is similar to a blood vessel and
      at different flow conditions (venous and arterial) could help to better identify the risk of
      bleeding in predisposed patients (von Willebrand factor deficiency, antiplatelet therapy).

      The objective of the study is to evaluate the performance of this new hemostasis test in
      whole blood and under flow conditions.

      Participation in the study is ad hoc and is limited to adding a maximum of 4 citrated tubes
      (20 mL or the equivalent of 4 teaspoons) and 1 EDTA tube (5mL) to a routine blood sample (for
      patients) or during blood donation (for controls).
observational model: Cohort
time perspective: Prospective
measure: Repeatability and reproducibility of the result in controls
time frame: Baseline
measure: Detection of antiplatelet or von Willebrand factor deficiency/major constitutional thrombopathy
time frame: Baseline
arm group label: Patients
description: Patients with von Willebrand disease or major constitutional thrombopathy or patients on antiplatelet drugs
arm group label: Controls
description: Blood donors at the French blood establishment in Burgundy Franche-Comté
intervention type: Biological
intervention name: Blood sampling
description: 4 citrated/PPACK tubes and 1 EDTA tube maximum
arm group label: Controls
arm group label: Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Emmanuel De Maistre
phone: 03 81 61 56 15
email: emmanuel.demaistre@chu-dijon.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Von Willebrand Diseases