<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/NCT02207205</url>
  </required_header>
  <id_info>
    <org_study_id>PER977-01-006</org_study_id>
    <nct_id>NCT02207205</nct_id>
  </id_info>
  <brief_title>Variability in the Measurement of WBCT Between Blood Drawn From Indwelling Catheters and Direct Venipuncture</brief_title>
  <official_title>A Study to Determine Variability in the Measurement of Whole Blood Clotting Time (WBCT) Between Blood Drawn From Indwelling Catheters and Direct Venipuncture</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>Duke Clinical Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. Determine if there is any difference between the whole blood clotting time results&#xD;
           obtained from blood drawn from indwelling catheters and direct venipuncture&#xD;
&#xD;
        2. Determine the intra-subject variability in both procedures&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      No investigational products were administered to any subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">June 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>Whole blood clotting time results from blood drawn from indwelling catheters and direct venipuncture</measure>
    <time_frame>single day sampling</time_frame>
    <description>Comparison of results in whole blood clotting time from blood sampled by direct venipuncture and from indwelling catheters as assessed by multiple technicians</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Catheter vs venipuncture blood samples</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Evaluation of whether there is any difference in results of whole blood clotting time in blood samples drawn from an indwelling catheter versus direct venipuncture</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Blood drawn from indwelling catheters versus direct venipuncture</intervention_name>
    <description>Evaluation of the source of blood samples on whole blood clotting time</description>
    <arm_group_label>Catheter vs venipuncture blood samples</arm_group_label>
  </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 (as determined by medical history) male and female subjects aged 18 to 65&#xD;
             years (inclusive) with suitable veins for venipuncture.&#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 drug (NSAID) or medications (including&#xD;
             aspirin) with a direct effect on hemostasis within 7 days of 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>Robert Noveck, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke Clinical Research Unit</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke Clinical Research Unit</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</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">August 4, 2014</study_first_posted>
  <last_update_submitted>April 3, 2018</last_update_submitted>
  <last_update_submitted_qc>April 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02207205
org study id: PER977-01-006
nct id: NCT02207205
lead sponsor: 
collaborator: 
has dmc: No
1. Determine if there is any difference between the whole blood clotting time results
           obtained from blood drawn from indwelling catheters and direct venipuncture

        2. Determine the intra-subject variability in both procedures
No investigational products were administered to any subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Whole blood clotting time results from blood drawn from indwelling catheters and direct venipuncture
time frame: single day sampling
description: Comparison of results in whole blood clotting time from blood sampled by direct venipuncture and from indwelling catheters as assessed by multiple technicians
arm group label: Catheter vs venipuncture blood samples
arm group type: Other
description: Evaluation of whether there is any difference in results of whole blood clotting time in blood samples drawn from an indwelling catheter versus direct venipuncture
intervention type: Drug
intervention name: Blood drawn from indwelling catheters versus direct venipuncture
description: Evaluation of the source of blood samples on whole blood clotting time
arm group label: Catheter vs venipuncture blood samples
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Robert Noveck, MD
role: Principal Investigator
affiliation: Duke Clinical Research Unit
facility: 
country: United States
responsible party type: Sponsor