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/NCT05993533</url>
    </required_header>
    <id_info>
      <org_study_id>2022PPRC04</org_study_id>
      <secondary_id>2023-A00466-39</secondary_id>
      <nct_id>NCT05993533</nct_id>
    </id_info>
    <brief_title>Comparison of the 'CTR' Ratio With Standard Haemostasis Parameters in the Follow-up of Patients Undergoing Heparin Therapy</brief_title>
    <acronym>QuantiXa</acronym>
    <official_title>Comparison of the 'CTR' Ratio With Standard Haemostasis Parameters in the Follow-up of Patients Undergoing Heparin Therapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Direction Centrale du Service de Santé des Armées</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Direction Centrale du Service de Santé des Armées</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 Quantra(r) hemostasis analyzer (Stago) is a recent addition to the family of global&#xD;
        hemostasis tests. It uses ultrasound-based technology to characterize the viscoelastic&#xD;
        properties of a whole blood sample during coagulation. The Qplus(r) cartridge consists of&#xD;
        independent channels, each containing different reagents that provide parallel measurements&#xD;
        of 6 parameters.&#xD;
  &#xD;
        This global test takes into account cellular elements such as platelets and red blood cells&#xD;
        in clot formation, and also explores fibrinolysis. In addition, this test is of particular&#xD;
        interest in delocalized biology, i.e. at the patient's bedside, and avoids the time-consuming&#xD;
        laboratory centrifugation stage required for routine analyzers.&#xD;
  &#xD;
        In practice, this test has been developed to monitor haemostasis in patients who may present&#xD;
        with a range of coagulopathies of various etiologies, but also in the management of&#xD;
        haemorrhagic patients, in order to adapt the administration of blood products in particular.&#xD;
  &#xD;
        The Quantra (r) analyzer could therefore be of interest since it could be deployed in&#xD;
        overseas operations to manage war casualties.&#xD;
  &#xD;
        Recent studies (EACTAIC-ICCVA congress, October 2021) have shown that there is a good&#xD;
        correlation between anti-Xa activity and the CTR (coagulation time ratio) parameter of the&#xD;
        Quantra cartridge Qplus (TM), suggesting that this automated system could be used to manage&#xD;
        anticoagulant therapy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 22, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 22, 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>Correlation between anti-Xa activity and 'CTR' parameter</measure>
      <time_frame>Through study completion (6 months)</time_frame>
      <description>The primary outcome is to compare anti-Xa activity results with the CTR (coagulation time ratio) parameter of the Qplus(r) cartridge</description>
    </primary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Venous Thromboembolic Disease</condition>
    <eligibility>
      <study_pop>
        <textblock>
          The study population is composed by hospitalized subjects under heparin therapy and who&#xD;
          needs to undergo a blood control&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients over 18 and affiliated to the french social security system&#xD;
  &#xD;
            -  Patients on curative heparin (low molecular weight heparin or non-fractionated&#xD;
               heparin) for whom anti-Xa activity is prescribed or planned by the clinician&#xD;
  &#xD;
            -  Samples taken between working hours&#xD;
  &#xD;
            -  No opposition to study participation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients unable to consent&#xD;
  &#xD;
            -  Anti-Xa activity not prescribed&#xD;
  &#xD;
            -  Patients on another anticoagulant treatment or not anticoagulated about it&#xD;
  &#xD;
            -  Samples taken during non-working hours&#xD;
  &#xD;
            -  Pregnant or breast-feeding women&#xD;
  &#xD;
            -  Insufficient language level for understanding the information note&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Aurore BOUSQUET</last_name>
      <phone>1 43 98 52 18</phone>
      <phone_ext>+33</phone_ext>
      <email>aurore.bousquet@intradef.gouv.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>HIA Bégin</name>
        <address>
          <city>Saint-Mandé</city>
          <zip>94160</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Aurore Bousquet</last_name>
        <phone>1 43 98 52 18</phone>
        <phone_ext>+33</phone_ext>
        <email>aurore.bousquet@intradef.gouv.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Anti Xa activity</keyword>
    <keyword>heparin treatment</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Thromboembolism</mesh_term>
    </condition_browse>
    <!-- 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/NCT05993533
  org study id: 2022PPRC04
  secondary id: 2023-A00466-39
  nct id: NCT05993533
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The Quantra(r) hemostasis analyzer (Stago) is a recent addition to the family of global
        hemostasis tests. It uses ultrasound-based technology to characterize the viscoelastic
        properties of a whole blood sample during coagulation. The Qplus(r) cartridge consists of
        independent channels, each containing different reagents that provide parallel measurements
        of 6 parameters.
  
        This global test takes into account cellular elements such as platelets and red blood cells
        in clot formation, and also explores fibrinolysis. In addition, this test is of particular
        interest in delocalized biology, i.e. at the patient's bedside, and avoids the time-consuming
        laboratory centrifugation stage required for routine analyzers.
  
        In practice, this test has been developed to monitor haemostasis in patients who may present
        with a range of coagulopathies of various etiologies, but also in the management of
        haemorrhagic patients, in order to adapt the administration of blood products in particular.
  
        The Quantra (r) analyzer could therefore be of interest since it could be deployed in
        overseas operations to manage war casualties.
  
        Recent studies (EACTAIC-ICCVA congress, October 2021) have shown that there is a good
        correlation between anti-Xa activity and the CTR (coagulation time ratio) parameter of the
        Quantra cartridge Qplus (TM), suggesting that this automated system could be used to manage
        anticoagulant therapy.
  observational model: Cohort
  time perspective: Prospective
  measure: Correlation between anti-Xa activity and 'CTR' parameter
  time frame: Through study completion (6 months)
  description: The primary outcome is to compare anti-Xa activity results with the CTR (coagulation time ratio) parameter of the Qplus(r) cartridge
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Aurore BOUSQUET
  phone: 1 43 98 52 18
  phone ext: +33
  email: aurore.bousquet@intradef.gouv.fr
  facility: 
  status: Recruiting
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Thromboembolism