<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/NCT04460664</url>
  </required_header>
  <id_info>
    <org_study_id>HEMCS-035</org_study_id>
    <nct_id>NCT04460664</nct_id>
  </id_info>
  <brief_title>Coagulation Changes Associated With COVID-19 Infection</brief_title>
  <official_title>Exploratory Assessment of the Coagulation Changes Associated With Severe Inflammation in COVID-19 Patients</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>
      This study will study the potential utility of the Quantra QPlus System in patients inflicted&#xD;
      with COVID-19 disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Quantra System is a fully integrated and automated in vitro diagnostic device which uses&#xD;
      SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic&#xD;
      properties of a whole blood sample during coagulation. The QPlus Cartridge can measure&#xD;
      hypocoagulable and hypercoagulable conditions resulting from the functional interaction of&#xD;
      the enzymatic and cellular components of coagulation and therefore, can be invaluable for&#xD;
      longitudinal monitoring of the coagulopathies reported in COVID-19 patients and the response&#xD;
      to anticoagulants.&#xD;
&#xD;
      This single-center, prospective, observational pilot study will characterize changes in the&#xD;
      coagulation status of patients with COVID-19 infection during their hospital stay using the&#xD;
      Quantra QPlus System.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2020</start_date>
  <completion_date type="Actual">January 26, 2022</completion_date>
  <primary_completion_date type="Actual">April 28, 2021</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>Quantra Clot Time results</measure>
    <time_frame>Within 24 hours of admission to the hospital</time_frame>
    <description>Coagulation function assessed by the Quantra</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantra Clot Time results</measure>
    <time_frame>48 to 72 hours after transfer to ICU</time_frame>
    <description>Coagulation function assessed by the Quantra</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantra Clot Time results</measure>
    <time_frame>1 to 24 hours prior to discharge from hospital</time_frame>
    <description>Coagulation function assessed by the Quantra</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantra Clot Stiffness results</measure>
    <time_frame>Upon arrival at hospital</time_frame>
    <description>Coagulation function assessed by the Quantra</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantra Clot Stiffness results</measure>
    <time_frame>48 to 72 hours after transfer to ICU</time_frame>
    <description>Coagulation function assessed by the Quantra</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantra Clot Stiffness results</measure>
    <time_frame>1 to 24 hours prior to discharge from hospital</time_frame>
    <description>Coagulation function assessed by the Quantra</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">15</enrollment>
  <condition>COVID</condition>
  <condition>Disseminated Intravascular Coagulation</condition>
  <condition>Coagulation Disorder</condition>
  <arm_group>
    <arm_group_label>Subjects admitted to floor</arm_group_label>
    <description>COVID-19 patients admitted to the floor as initial place of hospitalization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects admitted or transferred to ICU</arm_group_label>
    <description>COVID-19 patients admitted to the ICU as initial place of hospitalization or transferred to ICU from floor</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>Subjects admitted or transferred to ICU</arm_group_label>
    <arm_group_label>Subjects admitted to floor</arm_group_label>
    <other_name>QPlus Cartridge</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Potential subjects will be adult (&gt;=18 years) patients with a diagnosis of COVID-19 disease&#xD;
        admitted to the hospital for treatment of their disease. Subjects will be enrolled at a&#xD;
        ratio of 1 admitted to floor for every 2 admitted to ICU as initial place of&#xD;
        hospitalization.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is ≥ 18 years of age&#xD;
&#xD;
          -  Subject has a diagnosis of COVID-19 and has been admitted to the hospital&#xD;
&#xD;
          -  Subject has one or more risk factors for a poor outcome with COVID-10 disease:&#xD;
             advanced age (&gt;=60 years), morbid obesity, diabetes, COPD, CAD&#xD;
&#xD;
          -  Subject, or subject's legally authorized representative is willing and agrees to&#xD;
             provide 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.&#xD;
&#xD;
          -  Subject, or subject's legally authorized representative is unable or unwilling to&#xD;
             provide informed consent.&#xD;
&#xD;
          -  Subject is affected by a condition that, in the opinion of the treatment team, may&#xD;
             pose 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>Texas Tech University Health Sciences Center El Paso</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>May 11, 2022</last_update_submitted>
  <last_update_submitted_qc>May 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Viscoelastic testing</keyword>
  <keyword>Quantra</keyword>
  <keyword>COVID-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Hemostatic Disorders</mesh_term>
    <mesh_term>Blood Coagulation Disorders</mesh_term>
    <mesh_term>Disseminated Intravascular Coagulation</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/NCT04460664
org study id: HEMCS-035
nct id: NCT04460664
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
This study will study the potential utility of the Quantra QPlus System in patients inflicted
      with COVID-19 disease.
The Quantra System is a fully integrated and automated in vitro diagnostic device which uses
      SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic
      properties of a whole blood sample during coagulation. The QPlus Cartridge can measure
      hypocoagulable and hypercoagulable conditions resulting from the functional interaction of
      the enzymatic and cellular components of coagulation and therefore, can be invaluable for
      longitudinal monitoring of the coagulopathies reported in COVID-19 patients and the response
      to anticoagulants.

      This single-center, prospective, observational pilot study will characterize changes in the
      coagulation status of patients with COVID-19 infection during their hospital stay using the
      Quantra QPlus System.
observational model: Cohort
time perspective: Prospective
measure: Quantra Clot Time results
time frame: Within 24 hours of admission to the hospital
description: Coagulation function assessed by the Quantra
measure: Quantra Clot Time results
time frame: 48 to 72 hours after transfer to ICU
description: Coagulation function assessed by the Quantra
measure: Quantra Clot Time results
time frame: 1 to 24 hours prior to discharge from hospital
description: Coagulation function assessed by the Quantra
measure: Quantra Clot Stiffness results
time frame: Upon arrival at hospital
description: Coagulation function assessed by the Quantra
measure: Quantra Clot Stiffness results
time frame: 48 to 72 hours after transfer to ICU
description: Coagulation function assessed by the Quantra
measure: Quantra Clot Stiffness results
time frame: 1 to 24 hours prior to discharge from hospital
description: Coagulation function assessed by the Quantra
arm group label: Subjects admitted to floor
description: COVID-19 patients admitted to the floor as initial place of hospitalization
arm group label: Subjects admitted or transferred to ICU
description: COVID-19 patients admitted to the ICU as initial place of hospitalization or transferred to ICU from floor
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: Subjects admitted or transferred to ICU
arm group label: Subjects admitted to floor
other name: QPlus Cartridge
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
mesh term: COVID-19
mesh term: Hemostatic Disorders
mesh term: Blood Coagulation Disorders
mesh term: Disseminated Intravascular Coagulation
sharing ipd: No