<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/NCT04483245</url>
  </required_header>
  <id_info>
    <org_study_id>DE MAISTRE 2019</org_study_id>
    <nct_id>NCT04483245</nct_id>
  </id_info>
  <brief_title>Platelet Activation by a Collagen Analogue in Hemorrhagic Situations</brief_title>
  <acronym>CAPTURE</acronym>
  <official_title>Platelet Activation by a Collagen Analogue in Hemorrhagic Situations</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>
      Dijon University Hospital and the Dijon-based NVH Medicinal Company have developed a&#xD;
      recombinant mini-collagen NVH020B with platelet and Willebrand factor binding activity. Its&#xD;
      small size and granular, non-fibrillar presentation make it suitable for use as an injectable&#xD;
      hemostat in patients with a hemorrhage or other emergency under antiplatelet therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 7, 2021</start_date>
  <completion_date type="Actual">April 11, 2023</completion_date>
  <primary_completion_date type="Actual">April 11, 2023</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>The expression of P-selectin and activated GPIIb/IIIa (PAC1) at the surface of platelets in flow cytometry in response to NVH020B.</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>These 2 markers are absent on the surface of resting platelets. The expression of these 2 markers will make it possible to evaluate the role of the mini-collagen as an activator.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Platelet aggregation rate in response to NVH020B</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">83</enrollment>
  <condition>Collagen Analog</condition>
  <condition>Platelet Activation</condition>
  <condition>Hemorrhage</condition>
  <arm_group>
    <arm_group_label>controls</arm_group_label>
    <description>persons free of hemorrhage or haemostasis disorder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Haemorrhagic</arm_group_label>
    <description>Acute hemorrhagic patient</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ECMO</arm_group_label>
    <description>ECMO surgery patient with hemorrhagic complication</description>
  </arm_group>
  <arm_group>
    <arm_group_label>polytrauma</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Platelet disorder</arm_group_label>
    <description>Patient with an identified platelet disorder or treated with antiplatelet agents</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood sampling</intervention_name>
    <description>Blood sampling</description>
    <arm_group_label>ECMO</arm_group_label>
    <arm_group_label>Haemorrhagic</arm_group_label>
    <arm_group_label>Platelet disorder</arm_group_label>
    <arm_group_label>controls</arm_group_label>
    <arm_group_label>polytrauma</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients coming for a consultation at the Resouce Centre for Haemorrhagic Diseases and&#xD;
        Coagulopathies in the Internal Medicine and Haematology Department. Patients admitted to&#xD;
        the Emergency Department, and patients admitted to the operating theatre by the Surgical&#xD;
        Intensive Care Unit, the Neurovascular Emergency Department, or the Neurosurgery&#xD;
        Department.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  - person who has given their non-opposition to inclusion&#xD;
&#xD;
          -  adult&#xD;
&#xD;
          -  Healthy volunteers or controls (patients seen in consultation, without history of&#xD;
             hemmorhage, etc.).&#xD;
&#xD;
        or&#xD;
&#xD;
          -  patients with acute bleeding: polytraumatized, or hemorrhage or intracerebral&#xD;
             haemorrhage, or bleeding complications at the end surgery (in particular cardiac&#xD;
             surgery with ECMO) or&#xD;
&#xD;
          -  patients with antiplatelet therapy or&#xD;
&#xD;
          -  patients with thrombocytopenia/thrombopathy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  protected adults (curatorship, guardianship)&#xD;
&#xD;
          -  person deprived of their liberty by judicial or administrative decision&#xD;
&#xD;
          -  pregnant, parturient or breastfeeding woman&#xD;
&#xD;
          -  person unable to express their non-opposition&#xD;
&#xD;
          -  platelet transfusion on initial management&#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>
  <location>
    <facility>
      <name>Chu Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 24, 2023</last_update_submitted>
  <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2023</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>Hemorrhage</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/NCT04483245
org study id: DE MAISTRE 2019
nct id: NCT04483245
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Dijon University Hospital and the Dijon-based NVH Medicinal Company have developed a
      recombinant mini-collagen NVH020B with platelet and Willebrand factor binding activity. Its
      small size and granular, non-fibrillar presentation make it suitable for use as an injectable
      hemostat in patients with a hemorrhage or other emergency under antiplatelet therapy.
observational model: Cohort
time perspective: Prospective
measure: The expression of P-selectin and activated GPIIb/IIIa (PAC1) at the surface of platelets in flow cytometry in response to NVH020B.
time frame: Through study completion, an average of 1 year
description: These 2 markers are absent on the surface of resting platelets. The expression of these 2 markers will make it possible to evaluate the role of the mini-collagen as an activator.
measure: Platelet aggregation rate in response to NVH020B
time frame: Through study completion, an average of 1 year
arm group label: controls
description: persons free of hemorrhage or haemostasis disorder
arm group label: Haemorrhagic
description: Acute hemorrhagic patient
arm group label: ECMO
description: ECMO surgery patient with hemorrhagic complication
arm group label: polytrauma
arm group label: Platelet disorder
description: Patient with an identified platelet disorder or treated with antiplatelet agents
intervention type: Biological
intervention name: Blood sampling
description: Blood sampling
arm group label: ECMO
arm group label: Haemorrhagic
arm group label: Platelet disorder
arm group label: controls
arm group label: polytrauma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Hemorrhage