<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/NCT02978872</url>
  </required_header>
  <id_info>
    <org_study_id>HEMCS-005</org_study_id>
    <nct_id>NCT02978872</nct_id>
  </id_info>
  <brief_title>Quantra Determination of Coagulation Parameters in Arterial and Venous Blood</brief_title>
  <official_title>Comparison of Coagulation Parameters in Arterial and Venous Blood Measured Using the Quantra System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HemoSonics LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>HemoSonics LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Quantra™ System is a novel point-of-care diagnostic device designed to perform whole&#xD;
      blood coagulation analysis. This study compares Quantra measurements determined in arterial&#xD;
      versus venous blood samples obtained from patients undergoing cardiac surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Quantra System is a fully integrated and automated in vitro diagnostic device which&#xD;
      utilizes SEER Sonorheometry, an ultrasound-based technology, to characterize the dynamic&#xD;
      changes in the viscoelastic properties of a blood sample during coagulation and clot lysis.&#xD;
      Viscoelastic testing performed using existing technologies is typically performed on arterial&#xD;
      samples obtained from patients undergoing surgical procedures, although reference ranges for&#xD;
      these tests have been established for venous blood only.&#xD;
&#xD;
      The aim of this study is to evaluate potential differences between Quantra measurements&#xD;
      determined in arterial versus venous blood samples obtained from patients undergoing cardiac&#xD;
      surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2016</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</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 Clot Time and Clot Stiffness results between arterial and venous samples</measure>
    <time_frame>Up to 24 hours</time_frame>
    <description>Coagulation function assessed by Quantra at 2 time points (Baseline and either during cardiac bypass or post-bypass)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of Quantra results to standard coagulation test results in venous samples</measure>
    <time_frame>Up to 24 hours</time_frame>
    <description>Coagulation function assessed by Quantra and standard coagulation tests at 2 time points (Baseline and either during cardiac bypass or post-bypass)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of Quantra results to comparable ROTEM results in venous samples</measure>
    <time_frame>Up to 24 hours</time_frame>
    <description>Coagulation function assessed by Quantra and ROTEM at 2 time points (Baseline and either during cardiac bypass or post-bypass)</description>
  </secondary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Cardiac Surgery</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients scheduled for cardiac surgery, utilizing cardiopulmonary bypass, or&#xD;
        including placement of a ventricular assist device.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is scheduled for cardiac surgery, utilizing cardiopulmonary bypass, or&#xD;
             including placement of a ventricular assist device&#xD;
&#xD;
          -  Subject is ≥18 years&#xD;
&#xD;
          -  Subject is willing to participate and he/she has signed a consent form&#xD;
&#xD;
          -  Subject may participate if they have a history of bleeding or are on preoperative&#xD;
             anticoagulant therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is unable to provide written informed consent&#xD;
&#xD;
          -  Subject is younger than 18 years&#xD;
&#xD;
          -  Subject is incarcerated at the time of the study&#xD;
&#xD;
          -  Subject is currently enrolled in a study that may confound the results of the proposed&#xD;
             study&#xD;
&#xD;
          -  Subject is affected by a condition that, in the opinion of the surgical team, may pose&#xD;
             additional risks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>April 18, 2017</last_update_submitted>
  <last_update_submitted_qc>April 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiac surgery</keyword>
  <keyword>Quantra</keyword>
  <keyword>Viscoelastic testing</keyword>
  <keyword>Coagulation</keyword>
  <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/NCT02978872
org study id: HEMCS-005
nct id: NCT02978872
lead sponsor: 
collaborator: 
has dmc: No
The Quantra™ System is a novel point-of-care diagnostic device designed to perform whole
      blood coagulation analysis. This study compares Quantra measurements determined in arterial
      versus venous blood samples obtained from patients undergoing cardiac surgery.
The Quantra System is a fully integrated and automated in vitro diagnostic device which
      utilizes SEER Sonorheometry, an ultrasound-based technology, to characterize the dynamic
      changes in the viscoelastic properties of a blood sample during coagulation and clot lysis.
      Viscoelastic testing performed using existing technologies is typically performed on arterial
      samples obtained from patients undergoing surgical procedures, although reference ranges for
      these tests have been established for venous blood only.

      The aim of this study is to evaluate potential differences between Quantra measurements
      determined in arterial versus venous blood samples obtained from patients undergoing cardiac
      surgery.
observational model: Cohort
time perspective: Prospective
measure: Comparison of Clot Time and Clot Stiffness results between arterial and venous samples
time frame: Up to 24 hours
description: Coagulation function assessed by Quantra at 2 time points (Baseline and either during cardiac bypass or post-bypass)
measure: Comparison of Quantra results to standard coagulation test results in venous samples
time frame: Up to 24 hours
description: Coagulation function assessed by Quantra and standard coagulation tests at 2 time points (Baseline and either during cardiac bypass or post-bypass)
measure: Comparison of Quantra results to comparable ROTEM results in venous samples
time frame: Up to 24 hours
description: Coagulation function assessed by Quantra and ROTEM at 2 time points (Baseline and either during cardiac bypass or post-bypass)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No