xml: <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/NCT06033300</url>
    </required_header>
    <id_info>
      <org_study_id>PI2023_843_0047</org_study_id>
      <nct_id>NCT06033300</nct_id>
    </id_info>
    <brief_title>Characterization and Quantification of Platelet/Leukocyte Aggregates in Patients With Suspected Heparin-induced Thrombocytopenia</brief_title>
    <acronym>HITSTREAM</acronym>
    <official_title>Characterization and Quantification of Platelet/Leukocyte Aggregates in Patients With Suspected Heparin-induced Thrombocytopenia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Universitaire, Amiens</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Universitaire, Amiens</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>
        The investigators would like to analyze platelet/leukoplak activation, quantify and&#xD;
        morphologically characterize these aggregates using in vitro analysis, directly on whole&#xD;
        blood from adult patients with suspected HIT. This would enable to better describe the in&#xD;
        vivo pathophysiology of the HIT-suspect patient, and eliminate the need for platelet donors&#xD;
        to perform the usual confirmatory techniques, whose inter- and intra-individual variability&#xD;
        is very high. What's more, the SRA test, evaluated as the reference test, requires the use of&#xD;
        radioisotopes and is therefore only carried out in a few biological expertise centers,&#xD;
        resulting in a very long delay in the delivery of results. It should also be noted that, in&#xD;
        practice, HÉPARINE is immediately stopped in patients with suspected HIT, and they are put on&#xD;
        an expensive anticoagulant (DANAPAROIDE SODIQUE or ARGATROBAN) in curative doses until the&#xD;
        results of the confirmatory tests are back. In this serious, life-threatening condition, it&#xD;
        is essential to have a sensitive, specific test to confirm HIT as quickly as possible. Each&#xD;
        patient with suspected HIT (rapid &gt;30% reduction in platelet count after initiation of&#xD;
        heparin therapy) should have 4 tubes of 3.2% citrated whole blood (2.7ml) collected at the&#xD;
        time of suspected HIT (D0) and before any therapeutic switch (or 24 h max after switch). A&#xD;
        new sample (4 citrated tubes) will be taken at D4, D7 and D14 during hospitalization, in&#xD;
        patients who test positive for anti-PF4/H Ac. All patients with suspected HIT will follow the&#xD;
        standard diagnostic pathway, i.e. a screening test (immunological test for anti-PF4/heparin&#xD;
        antibodies, total Ig, ACL TOP, Werfen) followed by a confirmatory test (platelet aggregation&#xD;
        on TA-8V, STAGO and/or SRA). Doppler ultrasonography of the lower limbs will be performed in&#xD;
        HIT-suspect patients with a positive anti-PF4/H antibody test, as currently performed as part&#xD;
        of routine care.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 17, 2023</start_date>
    <completion_date type="Anticipated">April 2026</completion_date>
    <primary_completion_date type="Anticipated">April 2026</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>percentage of CD41a+/CD45- platelet clusters</measure>
      <time_frame>day 1</time_frame>
      <description>percentage of CD41a+/CD45- platelet clusters relative to platelet count by Flow Imaging ImageStream</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Heparin-induced Thrombocytopenia</condition>
    <condition>HIT</condition>
    <condition>Platelet Activation</condition>
    <condition>Platelets</condition>
    <condition>Leukocytes</condition>
    <condition>Platelet/Leukocyte Aggregates</condition>
    <condition>HITSTREAM</condition>
    <condition>Flow Cytometry</condition>
    <arm_group>
      <arm_group_label>suspected heparin-induced thrombocytopenia:</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>blood sample</intervention_name>
      <description>blood sample</description>
      <arm_group_label>suspected heparin-induced thrombocytopenia:</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &gt; 18 years&#xD;
  &#xD;
            -  Any adult patient suspected of having HIT, with a positive anti-PF4/H antibody test&#xD;
  &#xD;
            -  Patient signed consent to study participation&#xD;
  &#xD;
            -  Patient with social security coverage&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  All adult patients with suspected HIT and negative anti-PF4/H antibody test.&#xD;
  &#xD;
            -  Protected adults (guardianship, under curators) or deprived of liberty&#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_contact>
      <last_name>LE GUYADER MAILYS, MD</last_name>
      <phone>03.22.08.70.40</phone>
      <email>leguyader.mailys@chu-amiens.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>CHU Amiens</name>
        <address>
          <city>Amiens</city>
          <zip>80480</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Maïlys LE GUYADER, MD</last_name>
        <phone>03.22.08.70.00</phone>
        <email>leguyader.mailys@chu-amiens.fr</email>
      </contact>
      <investigator>
        <last_name>ABOU ARAB Osama, Pr</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>HAYE Guillaume, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>SALLE Valery, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>CANAPLE Sandrine, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>BASILE Damien, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Schmidt Jean, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>MALAQUIN Stéphanie, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>SOUDET Simon, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>HERMIDA Alexis, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Choukroun Gabriel, Pr</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Heparin-induced Thrombocytopenia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Thrombocytopenia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06033300
  org study id: PI2023_843_0047
  nct id: NCT06033300
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The investigators would like to analyze platelet/leukoplak activation, quantify and
        morphologically characterize these aggregates using in vitro analysis, directly on whole
        blood from adult patients with suspected HIT. This would enable to better describe the in
        vivo pathophysiology of the HIT-suspect patient, and eliminate the need for platelet donors
        to perform the usual confirmatory techniques, whose inter- and intra-individual variability
        is very high. What's more, the SRA test, evaluated as the reference test, requires the use of
        radioisotopes and is therefore only carried out in a few biological expertise centers,
        resulting in a very long delay in the delivery of results. It should also be noted that, in
        practice, HÉPARINE is immediately stopped in patients with suspected HIT, and they are put on
        an expensive anticoagulant (DANAPAROIDE SODIQUE or ARGATROBAN) in curative doses until the
        results of the confirmatory tests are back. In this serious, life-threatening condition, it
        is essential to have a sensitive, specific test to confirm HIT as quickly as possible. Each
        patient with suspected HIT (rapid >30% reduction in platelet count after initiation of
        heparin therapy) should have 4 tubes of 3.2% citrated whole blood (2.7ml) collected at the
        time of suspected HIT (D0) and before any therapeutic switch (or 24 h max after switch). A
        new sample (4 citrated tubes) will be taken at D4, D7 and D14 during hospitalization, in
        patients who test positive for anti-PF4/H Ac. All patients with suspected HIT will follow the
        standard diagnostic pathway, i.e. a screening test (immunological test for anti-PF4/heparin
        antibodies, total Ig, ACL TOP, Werfen) followed by a confirmatory test (platelet aggregation
        on TA-8V, STAGO and/or SRA). Doppler ultrasonography of the lower limbs will be performed in
        HIT-suspect patients with a positive anti-PF4/H antibody test, as currently performed as part
        of routine care.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: percentage of CD41a+/CD45- platelet clusters
  time frame: day 1
  description: percentage of CD41a+/CD45- platelet clusters relative to platelet count by Flow Imaging ImageStream
  arm group label: suspected heparin-induced thrombocytopenia:
  arm group type: Experimental
  intervention type: Biological
  intervention name: blood sample
  description: blood sample
  arm group label: suspected heparin-induced thrombocytopenia:
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: LE GUYADER MAILYS, MD
  phone: 03.22.08.70.40
  email: leguyader.mailys@chu-amiens.fr
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Thrombocytopenia
  sharing ipd: No