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/NCT06025708</url>
    </required_header>
    <id_info>
      <org_study_id>HEMCS-046</org_study_id>
      <nct_id>NCT06025708</nct_id>
    </id_info>
    <brief_title>Quantra QStat Sample Type Comparison</brief_title>
    <official_title>Impact of Sample Type on the Performance of the Quantra QStat System</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>HemoSonics LLC</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>HemoSonics LLC</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a single center prospective observational study to compare QStat parameter&#xD;
        measurements in arterial and venous blood samples collected in parallel from patients&#xD;
        undergoing liver transplantation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this single center prospective observational study, 25 cardiac surgery subjects will&#xD;
        enrolled, each with parallel artrial and venous samples collected at 3 time points to yield&#xD;
        75 matched samples for analysis on the Quantra System with the QStat Cartridge.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 5, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 20, 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>Comparison of QStat Clot time (CT) in arterial and venous samples</measure>
      <time_frame>During liver transplantation surgery</time_frame>
      <description>Coagulation function assessed in two sample types</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Comparison of QStat Clot stiffness (CS) in arterial and venous samples</measure>
      <time_frame>During liver transplantation surgery</time_frame>
      <description>Coagulation function assessed in two sample types</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Comparison of QStat Platelet Contribution to Clot stiffness (PCS) in arterial and venous samples</measure>
      <time_frame>During liver transplantation surgery</time_frame>
      <description>Coagulation function assessed in two sample types</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Comparison of QStat Fibrinogen Contribution to Clot stiffness (FCS) in arterial and venous samples</measure>
      <time_frame>During liver transplantation surgery</time_frame>
      <description>Coagulation function assessed in two sample types</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Comparison of QStat Clot Stabilty to Lysis (CSL) in arterial and venous samples</measure>
      <time_frame>During liver transplantation surgery</time_frame>
      <description>Coagulation function assessed in two sample types</description>
    </primary_outcome>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Coagulation Defect; Bleeding</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Diagnostic Test: Quantra QStat Cartridge</intervention_name>
      <description>Whole blood coagulation testing system</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients undergoing liver transplant surgery.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subject is &gt;=18 years&#xD;
  &#xD;
            -  Subject is scheduled for liver transplant surgery&#xD;
  &#xD;
            -  Subject or subject's legally authorized representative (LAR) is willing to provide&#xD;
               informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subject is younger than 18 years of age&#xD;
  &#xD;
            -  Subject is pregnant&#xD;
  &#xD;
            -  Subject is incarcerated at the time of the study&#xD;
  &#xD;
            -  Subject is affected by a condition that, in the opinion of the treatment team, may&#xD;
               pose additional risks&#xD;
  &#xD;
            -  Subject, or subject's LAR, is unable or unwilling to provide informed consent&#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>Deborah A Winegar, PhD</last_name>
      <phone>9192446990</phone>
      <email>dwinegar@hemosonics.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ohio State University Wexner Medical Center</name>
        <address>
          <city>Columbus</city>
          <state>Ohio</state>
          <zip>43210</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jeremy Reeves</last_name>
      </contact>
      <investigator>
        <last_name>Antolin Flores, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Quantra</keyword>
    <keyword>Liver transplantation</keyword>
    <keyword>Coagulation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hemostatic Disorders</mesh_term>
      <mesh_term>Blood Coagulation Disorders</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/NCT06025708
  org study id: HEMCS-046
  nct id: NCT06025708
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  This is a single center prospective observational study to compare QStat parameter
        measurements in arterial and venous blood samples collected in parallel from patients
        undergoing liver transplantation.
  In this single center prospective observational study, 25 cardiac surgery subjects will
        enrolled, each with parallel artrial and venous samples collected at 3 time points to yield
        75 matched samples for analysis on the Quantra System with the QStat Cartridge.
  observational model: Cohort
  time perspective: Prospective
  measure: Comparison of QStat Clot time (CT) in arterial and venous samples
  time frame: During liver transplantation surgery
  description: Coagulation function assessed in two sample types
  measure: Comparison of QStat Clot stiffness (CS) in arterial and venous samples
  time frame: During liver transplantation surgery
  description: Coagulation function assessed in two sample types
  measure: Comparison of QStat Platelet Contribution to Clot stiffness (PCS) in arterial and venous samples
  time frame: During liver transplantation surgery
  description: Coagulation function assessed in two sample types
  measure: Comparison of QStat Fibrinogen Contribution to Clot stiffness (FCS) in arterial and venous samples
  time frame: During liver transplantation surgery
  description: Coagulation function assessed in two sample types
  measure: Comparison of QStat Clot Stabilty to Lysis (CSL) in arterial and venous samples
  time frame: During liver transplantation surgery
  description: Coagulation function assessed in two sample types
  intervention type: Device
  intervention name: Diagnostic Test: Quantra QStat Cartridge
  description: Whole blood coagulation testing system
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Deborah A Winegar, PhD
  phone: 9192446990
  email: dwinegar@hemosonics.com
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Hemostatic Disorders
  mesh term: Blood Coagulation Disorders
  sharing ipd: No