<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/NCT03018548</url>
  </required_header>
  <id_info>
    <org_study_id>2014-1087</org_study_id>
    <nct_id>NCT03018548</nct_id>
  </id_info>
  <brief_title>Improvised Explosive Device (IED) Level Blasting of Human Blood With Slosh Prevention</brief_title>
  <official_title>Improvised Explosive Device (IED) Level Blasting of Human Blood With Slosh Prevention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To monitor changes in indicators of red cell damage such as extracellular hemoglobin,&#xD;
      potassium (K-ABL), and lactate dehydrogenase (LD) post blast exposure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Traumatic brain injury (TBI) causes significant morbidity and mortality, accompanied by high&#xD;
      related costs. Recent hypotheses concerning the pathophysiology of TBI invoke Strain Shear&#xD;
      Theory and Cavitation Theory. The invbestigators propose to test the importance of the latter&#xD;
      by directing blast waves into containers that are either partially or completely filled with&#xD;
      blood and measuring markers of lysis.&#xD;
&#xD;
      These experiments are designed to better understand the demonstrated effectiveness of mild&#xD;
      jugular compression according to the principle of the Queckenstedt Maneuver to reduce the&#xD;
      likelihood of TBI by filling up the compliance of the cranial space. A device (C-Collar) is&#xD;
      being developed by Q30 Labs, LLC (Q30), to accomplish this effect.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Lysis of blood cells</measure>
    <time_frame>within 2 hours</time_frame>
    <description>measure the lysis of blood cells exposed to blast from CO2 cartridge</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Brain Injuries</condition>
  <arm_group>
    <arm_group_label>subject blood drawns</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects will have blood drawn which will then be exposed to blast via CO2 cartridge</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood draw</intervention_name>
    <description>subjects will have blood drawn done. This blood will then be exposed to blasting with CO2 cartridge</description>
    <arm_group_label>subject blood drawns</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Normal healthy volunteer&#xD;
&#xD;
               -  Able to provide written consent&#xD;
&#xD;
               -  Must be 18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Unable to provide written consent&#xD;
&#xD;
               -  Recent penetrating brain trauma (within 6 months)&#xD;
&#xD;
               -  Under the age of 18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gregory D Myer, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cincinnati Childrens Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinnati Childrens Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>August 20, 2020</last_update_submitted>
  <last_update_submitted_qc>August 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03018548
org study id: 2014-1087
nct id: NCT03018548
lead sponsor: 
has dmc: Yes
To monitor changes in indicators of red cell damage such as extracellular hemoglobin,
      potassium (K-ABL), and lactate dehydrogenase (LD) post blast exposure.
Traumatic brain injury (TBI) causes significant morbidity and mortality, accompanied by high
      related costs. Recent hypotheses concerning the pathophysiology of TBI invoke Strain Shear
      Theory and Cavitation Theory. The invbestigators propose to test the importance of the latter
      by directing blast waves into containers that are either partially or completely filled with
      blood and measuring markers of lysis.

      These experiments are designed to better understand the demonstrated effectiveness of mild
      jugular compression according to the principle of the Queckenstedt Maneuver to reduce the
      likelihood of TBI by filling up the compliance of the cranial space. A device (C-Collar) is
      being developed by Q30 Labs, LLC (Q30), to accomplish this effect.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Lysis of blood cells
time frame: within 2 hours
description: measure the lysis of blood cells exposed to blast from CO2 cartridge
arm group label: subject blood drawns
arm group type: Experimental
description: subjects will have blood drawn which will then be exposed to blast via CO2 cartridge
intervention type: Other
intervention name: blood draw
description: subjects will have blood drawn done. This blood will then be exposed to blasting with CO2 cartridge
arm group label: subject blood drawns
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gregory D Myer, PhD
role: Principal Investigator
affiliation: Cincinnati Childrens Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Brain Injuries
sharing ipd: No