<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/NCT03296982</url>
  </required_header>
  <id_info>
    <org_study_id>PER977-01-010</org_study_id>
    <nct_id>NCT03296982</nct_id>
  </id_info>
  <brief_title>Variability of Whole Blood Clotting Time Measurements in Ex Vivo Human Blood Samples Spiked With Anticoagulants</brief_title>
  <official_title>A Study to Determine the Inter/Intra Observer and Intra-Subject Variability of Whole Blood Clotting Time Measurements in Ex Vivo Human Blood Samples Spiked With Anticoagulants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Quintiles, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>AMAG Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will assess the distribution and variability of whole blood clotting time (WBCT)&#xD;
      measurement in human blood collected from healthy volunteers that is untreated and spiked&#xD;
      with predetermined concentrations of edoxaban or enoxaparin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twelve healthy volunteers aged 18 to 65 years (6 subjects per spiking anticoagulant) will be&#xD;
      enrolled. A total of 8 blood samples (12 mL/sample) will be collected by direct venipuncture.&#xD;
      The samples from will be spiked with predetermined concentrations of edoxaban or enoxaparin&#xD;
      (baseline, saline control and 6 specified concentrations of anticoagulant).&#xD;
&#xD;
      Each blood sample will be tested for whole blood clotting time (WBCT), Point of Care&#xD;
      activated partial thromboplastin time (aPTT) and prothrombin time (PT).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Distribution and variability of WBCT measurements</measure>
    <time_frame>1 day</time_frame>
    <description>Assessment of the analytical measurement range, reproducibility and precision of WBCT measurement in human blood spiked with predetermined concentrations of enoxparin and edoxaban</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Blood Sample</arm_group_label>
    <description>Blood will be sampled by direct venipuncture on 8 occasions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood drawn by direct venipuncture</intervention_name>
    <description>Subjects will have blood sampled (12 mL/sample) a total of 8 times by direct venipuncture. Samples will be spiked with predetermined concentrations of anticoagulants, or saline sham.</description>
    <arm_group_label>Blood Sample</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>edoxaban</intervention_name>
    <arm_group_label>Blood Sample</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enoxaparin</intervention_name>
    <arm_group_label>Blood Sample</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline sham</intervention_name>
    <arm_group_label>Blood Sample</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        healthy volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed and dated informed consent form&#xD;
&#xD;
          2. Healthy male and female subjects aged 18 to 65 years (inclusive) with suitable veins&#xD;
             for venipuncture -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who cannot communicate reliably with the Investigator&#xD;
&#xD;
          2. History of major bleeding or major trauma within the 6 months prior to signing&#xD;
             informed consent&#xD;
&#xD;
          3. Propensity to bleeding (i.e. due to recent trauma, surgery, peptic ulcer,&#xD;
             gastrointestinal bleeding or hemorrhoids)&#xD;
&#xD;
          4. Significant infection or known inflammatory process in the 2 weeks prior to screening&#xD;
&#xD;
          5. Active smoker or current use of any tobacco products or use within 3 months prior to&#xD;
             signing informed consent&#xD;
&#xD;
          6. Treatment with any investigation product or therapy within 30 days prior to screening&#xD;
&#xD;
          7. Received non-steroidal antiinflammatory drugs or medications (including anticoagulants&#xD;
             or aspirin) with a direct effect on hemostasis within 7 days of blood sampling&#xD;
&#xD;
          8. Unwilling to comply with the procedures in the protocol&#xD;
&#xD;
          9. Currently enrolled in any other study -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Scott Rasmussen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Quintiles Phase 1 Services, LLC Overland Park KS</affiliation>
  </overall_official>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>December 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>May 19, 2020</last_update_submitted>
  <last_update_submitted_qc>May 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Whole blood clotting time</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Enoxaparin</mesh_term>
    <mesh_term>Edoxaban</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03296982
org study id: PER977-01-010
nct id: NCT03296982
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The study will assess the distribution and variability of whole blood clotting time (WBCT)
      measurement in human blood collected from healthy volunteers that is untreated and spiked
      with predetermined concentrations of edoxaban or enoxaparin.
Twelve healthy volunteers aged 18 to 65 years (6 subjects per spiking anticoagulant) will be
      enrolled. A total of 8 blood samples (12 mL/sample) will be collected by direct venipuncture.
      The samples from will be spiked with predetermined concentrations of edoxaban or enoxaparin
      (baseline, saline control and 6 specified concentrations of anticoagulant).

      Each blood sample will be tested for whole blood clotting time (WBCT), Point of Care
      activated partial thromboplastin time (aPTT) and prothrombin time (PT).
observational model: Cohort
time perspective: Prospective
measure: Distribution and variability of WBCT measurements
time frame: 1 day
description: Assessment of the analytical measurement range, reproducibility and precision of WBCT measurement in human blood spiked with predetermined concentrations of enoxparin and edoxaban
arm group label: Blood Sample
description: Blood will be sampled by direct venipuncture on 8 occasions.
intervention type: Other
intervention name: Blood drawn by direct venipuncture
description: Subjects will have blood sampled (12 mL/sample) a total of 8 times by direct venipuncture. Samples will be spiked with predetermined concentrations of anticoagulants, or saline sham.
arm group label: Blood Sample
intervention type: Drug
intervention name: edoxaban
arm group label: Blood Sample
intervention type: Drug
intervention name: Enoxaparin
arm group label: Blood Sample
intervention type: Drug
intervention name: Saline sham
arm group label: Blood Sample
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Scott Rasmussen, MD
role: Principal Investigator
affiliation: Quintiles Phase 1 Services, LLC Overland Park KS
responsible party type: Sponsor
mesh term: Thrombosis
mesh term: Enoxaparin
mesh term: Edoxaban