<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/NCT04470505</url>
  </required_header>
  <id_info>
    <org_study_id>260236</org_study_id>
    <nct_id>NCT04470505</nct_id>
  </id_info>
  <brief_title>Optimizing Platelet Isolation (The Cell Study)</brief_title>
  <official_title>Optimizing Platelet Isolation for Measures of Human Platelet Mitochondrial Respiration (The Cell Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arkansas Children's Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Arkansas Children's Hospital Research Institute</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>
      The research study is about blood cells (platelets) and their power houses (mitochondria).&#xD;
      The investigators want to learn about their behavior in order to ensure that our laboratory&#xD;
      procedures are generating optimal results.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objectives of this study are to assess platelet activation following standard laboratory&#xD;
      procedures used in the process of measuring platelet mitochondrial function, and to determine&#xD;
      the optimal amount of digitonin needed to permeabilize platelet cell membrane.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 6, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2023</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>Platelet activation from isolated platelets</measure>
    <time_frame>day 1</time_frame>
    <description>Whole blood will be collected following an overnight fast, and platelets isolated using standard procedures. Platelet activation markers (e.g., CD62P ) will be measured using flow cytometric analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Platelet activation measured in whole blood</measure>
    <time_frame>day 1</time_frame>
    <description>Whole blood will be collected following an overnight fast. Platelet activation will be measured in whole blood by the expression CD62P</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Platelet reactivity measured in whole blood</measure>
    <time_frame>day 1</time_frame>
    <description>Whole blood will be collected following an overnight fast. Platelet reactivity will be measured in whole blood with adenosine diphosphate (ADP).</description>
  </secondary_outcome>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Healthy</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        25-35 years old&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 25-35&#xD;
&#xD;
          -  All races&#xD;
&#xD;
          -  All ethnicity&#xD;
&#xD;
          -  18.5 - 30 BMI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  smoking&#xD;
&#xD;
          -  Aspirin intake&#xD;
&#xD;
          -  Recreational drug use&#xD;
&#xD;
          -  Alcohol intake more than 3 times per week&#xD;
&#xD;
          -  Self-reported possibility of current pregnancy&#xD;
&#xD;
          -  Known diagnosis of:&#xD;
&#xD;
          -  Pre-diabetes&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  High cholesterol&#xD;
&#xD;
          -  High triglycerides&#xD;
&#xD;
          -  Hypertension&#xD;
&#xD;
          -  Anemia&#xD;
&#xD;
          -  Autism spectrum disorder&#xD;
&#xD;
          -  Attention deficit hyperactivity disorder (ADHD)&#xD;
&#xD;
          -  Attention deficit disorder (ADD)&#xD;
&#xD;
          -  Severe asthma&#xD;
&#xD;
          -  Refusal to stop taking nutritional supplements&#xD;
&#xD;
          -  Any other pre-existing medical condition that requires daily medication as determined&#xD;
             by the investigators to affect outcome of interest&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Arkansas Children's Nutrition Center</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>March 2, 2023</last_update_submitted>
  <last_update_submitted_qc>March 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2023</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/NCT04470505
org study id: 260236
nct id: NCT04470505
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The research study is about blood cells (platelets) and their power houses (mitochondria).
      The investigators want to learn about their behavior in order to ensure that our laboratory
      procedures are generating optimal results.
The objectives of this study are to assess platelet activation following standard laboratory
      procedures used in the process of measuring platelet mitochondrial function, and to determine
      the optimal amount of digitonin needed to permeabilize platelet cell membrane.
observational model: Cohort
time perspective: Prospective
measure: Platelet activation from isolated platelets
time frame: day 1
description: Whole blood will be collected following an overnight fast, and platelets isolated using standard procedures. Platelet activation markers (e.g., CD62P ) will be measured using flow cytometric analysis.
measure: Platelet activation measured in whole blood
time frame: day 1
description: Whole blood will be collected following an overnight fast. Platelet activation will be measured in whole blood by the expression CD62P
measure: Platelet reactivity measured in whole blood
time frame: day 1
description: Whole blood will be collected following an overnight fast. Platelet reactivity will be measured in whole blood with adenosine diphosphate (ADP).
blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 25 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor