<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/NCT02997111</url>
  </required_header>
  <id_info>
    <org_study_id>27619</org_study_id>
    <nct_id>NCT02997111</nct_id>
  </id_info>
  <brief_title>PFA-100 Responsive to Effect of Energy Drinks on Platelet Function</brief_title>
  <official_title>Is the PFA-100 Responsive to the Effect of Energy Drinks on Platelet Function Changes?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the responsiveness of the Platelet Function Analyzer (PFA-100) to the&#xD;
      effect of energy drinks on platelet function. Participants' will have blood drawn prior to&#xD;
      and 60 minutes after ingesting 250ml of a commercially available sugar-free energy drink.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two previous studies have demonstrated increased platelet aggregation 60 minutes after&#xD;
      drinking a commercially available sugar-free energy drink. These studies utilized traditional&#xD;
      platelet function studies, such as light transmission aggregometry (LTA), where platelet&#xD;
      function is examined while adding varying concentrations of a panel of agonist to platelets.&#xD;
      These studies are technically difficult, time intensive studies requiring specialized&#xD;
      laboratories. They are relatively non-physiologic and do not mimic platelet response to&#xD;
      vessel wall damage. Other tests better represent the reactions to vessel wall damage,&#xD;
      including the PFA-100, which measures platelet aggregation and adhesion under conditions of&#xD;
      high shear.&#xD;
&#xD;
      Overall, PFA-100 is less expensive, requires less technical skill, and is less time consuming&#xD;
      than LTA. It has been utilized in bleeding disorders and is demonstrating promise as a marker&#xD;
      of thrombophilia. PFA-100 has demonstrated sensitivity to drug and dietary effects. It has&#xD;
      also shown differences in closure time between sedentary and athletic individuals PFA-100 has&#xD;
      not been used to investigate the effect of energy drinks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 14, 2017</start_date>
  <completion_date type="Actual">June 20, 2017</completion_date>
  <primary_completion_date type="Actual">June 9, 2017</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>Closure time</measure>
    <time_frame>one hour</time_frame>
    <description>Agonist induced platelet activation and aggregation resulting in occlusion of the aperture and cessation of blood flow termed the closure time</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>blood pressure</measure>
    <time_frame>one hour (every 15 minutes)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pulse</measure>
    <time_frame>one hour (every 15 minutes)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Platelet Function</condition>
  <condition>Thrombosis</condition>
  <arm_group>
    <arm_group_label>Energy drink</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Single group study. Platelet function analyzed with PFA-100 before and 60 minutes after ingestion of 250 ml sugar-free energy drink</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PFA-100</intervention_name>
    <description>The PFA-100 will be used to assess platelet function before and after energy drink consumption.</description>
    <arm_group_label>Energy drink</arm_group_label>
    <other_name>Platelet function analyzer</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a history of consuming at least one energy drink beverage in the past 6 months without&#xD;
             adverse effects;&#xD;
&#xD;
          -  engage in moderate to strenuous physical activity more than 3 days per week.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known thromboembolic risk including protein C or S deficiency, anti-thrombin III&#xD;
             deficiency, Factor V Leiden;&#xD;
&#xD;
          -  history of thromboembolic event;&#xD;
&#xD;
          -  current or previous anti-coagulation therapy, anti-platelet therapy, calcium&#xD;
             antagonists; - current tricyclic antidepressant therapy, current selective serotonin&#xD;
             re-uptake inhibitor therapy; antibiotic therapy; or famotidine therapy;&#xD;
&#xD;
          -  acute illness;&#xD;
&#xD;
          -  pregnancy;&#xD;
&#xD;
          -  hemophilia;&#xD;
&#xD;
          -  significant history of cardiovascular disease and/or diabetes mellitus;&#xD;
&#xD;
          -  history of adverse effect of energy drinks.&#xD;
&#xD;
          -  Inability to comply with pre-test dietary and activity requirements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katherine Newsham, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Louis University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saint Louis University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>June 21, 2017</last_update_submitted>
  <last_update_submitted_qc>June 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Katherine Newsham PhD, ATC</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share individual participant data with other researchers</ipd_description>
  </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/NCT02997111
org study id: 27619
nct id: NCT02997111
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the responsiveness of the Platelet Function Analyzer (PFA-100) to the
      effect of energy drinks on platelet function. Participants' will have blood drawn prior to
      and 60 minutes after ingesting 250ml of a commercially available sugar-free energy drink.
Two previous studies have demonstrated increased platelet aggregation 60 minutes after
      drinking a commercially available sugar-free energy drink. These studies utilized traditional
      platelet function studies, such as light transmission aggregometry (LTA), where platelet
      function is examined while adding varying concentrations of a panel of agonist to platelets.
      These studies are technically difficult, time intensive studies requiring specialized
      laboratories. They are relatively non-physiologic and do not mimic platelet response to
      vessel wall damage. Other tests better represent the reactions to vessel wall damage,
      including the PFA-100, which measures platelet aggregation and adhesion under conditions of
      high shear.

      Overall, PFA-100 is less expensive, requires less technical skill, and is less time consuming
      than LTA. It has been utilized in bleeding disorders and is demonstrating promise as a marker
      of thrombophilia. PFA-100 has demonstrated sensitivity to drug and dietary effects. It has
      also shown differences in closure time between sedentary and athletic individuals PFA-100 has
      not been used to investigate the effect of energy drinks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Closure time
time frame: one hour
description: Agonist induced platelet activation and aggregation resulting in occlusion of the aperture and cessation of blood flow termed the closure time
measure: blood pressure
time frame: one hour (every 15 minutes)
measure: pulse
time frame: one hour (every 15 minutes)
arm group label: Energy drink
arm group type: Other
description: Single group study. Platelet function analyzed with PFA-100 before and 60 minutes after ingestion of 250 ml sugar-free energy drink
intervention type: Device
intervention name: PFA-100
description: The PFA-100 will be used to assess platelet function before and after energy drink consumption.
arm group label: Energy drink
other name: Platelet function analyzer
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Katherine Newsham, PhD
role: Principal Investigator
affiliation: St. Louis University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Katherine Newsham PhD, ATC
investigator title: Associate Professor
mesh term: Thrombosis
sharing ipd: No
ipd description: No plan to share individual participant data with other researchers