<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/NCT04490759</url>
  </required_header>
  <id_info>
    <org_study_id>HEMCS-020</org_study_id>
    <nct_id>NCT04490759</nct_id>
  </id_info>
  <brief_title>QStat Pilot Reference Range Study</brief_title>
  <official_title>Reference Range Pilot Study for the Quantra Analyzer With the QStat Cartridge</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_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective is to determine the initial reference range intervals for the parameters&#xD;
      reported by the Quantra System with the QStat Cartridge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single center prospective, observational study of a healthy adult population with&#xD;
      normal coagulation function to determine the initial reference range intervals for the&#xD;
      parameters reported by the Quantra System with the QStat Cartridge. The threshold for the&#xD;
      Clot Stability to Lysis (CSL) parameter will be determined from the CSL reference range.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 29, 2018</start_date>
  <completion_date type="Actual">July 16, 2019</completion_date>
  <primary_completion_date type="Actual">December 4, 2018</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>Reference range intervals for measurement of Clot Time (CT) parameter</measure>
    <time_frame>Baseline, determined from a single blood draw</time_frame>
    <description>Reference range intervals determined in this study will serve as the reference range for CT on the QStat Cartridge when it is commercially available.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reference range intervals for measurement of Clot Stiffness (CS) parameter</measure>
    <time_frame>Baseline, determined from a single blood draw</time_frame>
    <description>Reference range intervals determined in this study will serve as the reference range for CS on the QStat Cartridge when it is commercially available.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reference range intervals for measurement of Fibrinogen Contribution to Clot Stiffness (FCS) parameter</measure>
    <time_frame>Baseline, determined from a single blood draw</time_frame>
    <description>Reference range intervals determined in this study will serve as the reference range for FCS on the QStat Cartridge when it is commercially available.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reference range intervals for measurement of Platelet Contribution to Clot Stiffness (PCS) parameter</measure>
    <time_frame>Baseline, determined from a single blood draw</time_frame>
    <description>Reference range intervals determined in this study will serve as the reference range for PCS on the QStat Cartridge when it is commercially available.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reference range intervals for measurement of Clot Stability to Lysis (CSL) parameter</measure>
    <time_frame>Baseline, determined from a single blood draw</time_frame>
    <description>Reference range intervals determined in this study will serve as the reference range for CSL on the QStat Cartridge when it is commercially available.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Coagulation Disorder</condition>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <description>Blood samples from healthy volunteers analyzed on the Quantra System</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Quantra System</intervention_name>
    <description>Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.</description>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <other_name>QStat Cartridge</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult volunteers with normal coagulation function, approximately equal numbers of males and&#xD;
        females across three age group categories (18-30, 31-50 and &gt;50 years). The racial and&#xD;
        ethnic profiles will be representative of the populations at the site.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is 18 years or older&#xD;
&#xD;
          -  Subject is willing to participate and has signed a consent form&#xD;
&#xD;
          -  Subject's laboratory coagulation test results at screening are within each test's&#xD;
             normal reference range.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is younger than 18 years&#xD;
&#xD;
          -  Subject has a history of a coagulation disorder&#xD;
&#xD;
          -  Subject is pregnant or lactating&#xD;
&#xD;
          -  Subject is currently taking medications known to alter coagulation&#xD;
&#xD;
          -  Subject has one or more laboratory coagulation test restuls outside of the normal&#xD;
             reference range at screening&#xD;
&#xD;
          -  Subject had a blood transfusion or surgery within the last month&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Excessive alcohol consumption&#xD;
&#xD;
          -  Subject is unable to provide written informed consent&#xD;
&#xD;
          -  Subject is incarcerated at the time of the study&#xD;
&#xD;
          -  Subject previously participated in this study&#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>M3 Wake Research</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</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>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>


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/NCT04490759
org study id: HEMCS-020
nct id: NCT04490759
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
The objective is to determine the initial reference range intervals for the parameters
      reported by the Quantra System with the QStat Cartridge.
This is a single center prospective, observational study of a healthy adult population with
      normal coagulation function to determine the initial reference range intervals for the
      parameters reported by the Quantra System with the QStat Cartridge. The threshold for the
      Clot Stability to Lysis (CSL) parameter will be determined from the CSL reference range.
observational model: Cohort
time perspective: Prospective
measure: Reference range intervals for measurement of Clot Time (CT) parameter
time frame: Baseline, determined from a single blood draw
description: Reference range intervals determined in this study will serve as the reference range for CT on the QStat Cartridge when it is commercially available.
measure: Reference range intervals for measurement of Clot Stiffness (CS) parameter
time frame: Baseline, determined from a single blood draw
description: Reference range intervals determined in this study will serve as the reference range for CS on the QStat Cartridge when it is commercially available.
measure: Reference range intervals for measurement of Fibrinogen Contribution to Clot Stiffness (FCS) parameter
time frame: Baseline, determined from a single blood draw
description: Reference range intervals determined in this study will serve as the reference range for FCS on the QStat Cartridge when it is commercially available.
measure: Reference range intervals for measurement of Platelet Contribution to Clot Stiffness (PCS) parameter
time frame: Baseline, determined from a single blood draw
description: Reference range intervals determined in this study will serve as the reference range for PCS on the QStat Cartridge when it is commercially available.
measure: Reference range intervals for measurement of Clot Stability to Lysis (CSL) parameter
time frame: Baseline, determined from a single blood draw
description: Reference range intervals determined in this study will serve as the reference range for CSL on the QStat Cartridge when it is commercially available.
arm group label: Healthy volunteers
description: Blood samples from healthy volunteers analyzed on the Quantra System
intervention type: Diagnostic Test
intervention name: Quantra System
description: Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
arm group label: Healthy volunteers
other name: QStat Cartridge
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: United States
responsible party type: Sponsor
mesh term: Hemostatic Disorders
mesh term: Blood Coagulation Disorders
sharing ipd: No