<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/NCT02205827</url>
  </required_header>
  <id_info>
    <org_study_id>PER977-01-005</org_study_id>
    <nct_id>NCT02205827</nct_id>
  </id_info>
  <brief_title>A Study to Determine the Inter/Intra Observer and Intra-subject Variability of Whole Blood Clotting Time Measurements</brief_title>
  <official_title>A Study to Determine the Inter/Intra Observer and Intra-subject Variability of Whole Blood Clotting Time Measurements</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to characterize the distribution and sources of variability in&#xD;
      whole blood clotting time (WBCT) measurements in human blood collected from healthy&#xD;
      volunteers by 5 different technicians.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      No investigational product was administered to any subject in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Variability in whole blood clotting time measurement</measure>
    <time_frame>1 day</time_frame>
    <description>Assessment of variability in whole blood clotting time measurements in human blood collected from volunteers in across five technicians</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Single-arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>healthy volunteers</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Single-arm</intervention_name>
    <description>collection of blood for assessment of whole blood clotting time</description>
    <arm_group_label>Single-arm</arm_group_label>
    <other_name>Whole Blood Clotting Time assessment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed and dated, written informed consent (Institutional Review Board [IRB]-approved&#xD;
             informed consent form [ICF]).&#xD;
&#xD;
          2. Healthy male and female subjects aged 18 to 65 years (inclusive) with suitable veins&#xD;
             for venipuncture. (Healthy as determined by medical history)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Healthy subjects who do not conform to the above inclusion criteria.&#xD;
&#xD;
          2. Healthy subjects who cannot communicate reliably with the Investigator.&#xD;
&#xD;
          3. History of major bleeding or major trauma within the past 6 months&#xD;
&#xD;
          4. Healthy volunteer with a propensity to bleed (i.e. due to recent trauma, recent&#xD;
             surgery, peptic ulcer, active or recent gastrointestinal bleeding or bleeding from&#xD;
             hemorrhoids).&#xD;
&#xD;
          5. Significant infection or known inflammatory process within 2 weeks of screening.&#xD;
&#xD;
          6. Treatment with any investigational products or therapies within 30 days (or 5 half&#xD;
             lives, whichever is greater) prior to screening.&#xD;
&#xD;
          7. Received non-steroidal anti-inflammatory (NSAID) or medications (including any type of&#xD;
             anticoagulant or aspirin [ASA]) with a direct effect on hemostasis within 7 days of&#xD;
             testing&#xD;
&#xD;
          8. Unwillingness or inability to comply with procedures required in this protocol.&#xD;
&#xD;
          9. Subjects who are concurrently enrolled in any other clinical 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>James Costin, MD</last_name>
    <role>Study Director</role>
    <affiliation>Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Quintiles Phase I Services, LLC</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</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>
  <!-- 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/NCT02205827
org study id: PER977-01-005
nct id: NCT02205827
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the study is to characterize the distribution and sources of variability in
      whole blood clotting time (WBCT) measurements in human blood collected from healthy
      volunteers by 5 different technicians.
No investigational product was administered to any subject in this study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Variability in whole blood clotting time measurement
time frame: 1 day
description: Assessment of variability in whole blood clotting time measurements in human blood collected from volunteers in across five technicians
arm group label: Single-arm
arm group type: No Intervention
description: healthy volunteers
intervention type: Other
intervention name: Single-arm
description: collection of blood for assessment of whole blood clotting time
arm group label: Single-arm
other name: Whole Blood Clotting Time assessment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: James Costin, MD
role: Study Director
affiliation: Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Thrombosis