<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/NCT02262286</url>
  </required_header>
  <id_info>
    <org_study_id>9GP-02-10DELK14</org_study_id>
    <nct_id>NCT02262286</nct_id>
  </id_info>
  <brief_title>MIND (Management of Traumatic Brain Injury Diagnosis)</brief_title>
  <acronym>MIND</acronym>
  <official_title>Study to Procure Human Specimens for Use in the Diagnosis and Management of Traumatic Brain Injury and Other Related Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Diagnostics Division</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Diagnostics Division</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Procure blood specimens from individuals presenting to the emergency department with&#xD;
      suspected brain injury.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of specific biomarker(s) for brain injury</measure>
    <time_frame>48 hours</time_frame>
    <description>Measurement of specific biomarkers to detect brain injury (mild to severe). using 2 or more serial draws from subjects. The biomarkers tested will include established biomarkers s100B, GFAP (Glial Fibrillary Acidic Protein) and also proprietary novel protein and lipid biomarkers that are being studied in discovery research.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">239</enrollment>
  <condition>Brain Injury</condition>
  <arm_group>
    <arm_group_label>Brain Injury</arm_group_label>
    <description>Brain Injury</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Healthy, or Head Trauma, or Orthopedic Trauma, or Poly-Trauma</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma and serum samples stored at -70C or colder&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals presenting to the ED within 6 hours of experiencing a head trauma, or bone&#xD;
        fractions only.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed Consent Form Signed&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  For women of child-bearing age: Not known to be pregnant AND&#xD;
&#xD;
          -  Head Trauma within 6 hours of ED presentation with Glasgow Coma Scores from 3-8&#xD;
             (Severe Injury), 9-13 (Moderate Injury), or 14-15 (Mild Injury); OR&#xD;
&#xD;
          -  Head trauma within 6 hours of ED presentation with Glasgow Coma Score of 15; OR&#xD;
&#xD;
          -  Bone fracture or poly-traumas, both with no head trauma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known pre-existing neurological condition that causes observed symptoms&#xD;
&#xD;
          -  Recent history of head injury or seizures (within 1 year of current ED presentation)&#xD;
&#xD;
          -  Prisoner&#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>Peter Biberthaler, MD/PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinikum reichs der Isar</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinikum rechts der Isar</name>
      <address>
        <city>Munich</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>February 8, 2017</last_update_submitted>
  <last_update_submitted_qc>February 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Brain Injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT02262286
org study id: 9GP-02-10DELK14
nct id: NCT02262286
lead sponsor: 
has dmc: No
Procure blood specimens from individuals presenting to the emergency department with
      suspected brain injury.
observational model: Case-Control
time perspective: Prospective
measure: Measurement of specific biomarker(s) for brain injury
time frame: 48 hours
description: Measurement of specific biomarkers to detect brain injury (mild to severe). using 2 or more serial draws from subjects. The biomarkers tested will include established biomarkers s100B, GFAP (Glial Fibrillary Acidic Protein) and also proprietary novel protein and lipid biomarkers that are being studied in discovery research.
arm group label: Brain Injury
description: Brain Injury
arm group label: Control
description: Healthy, or Head Trauma, or Orthopedic Trauma, or Poly-Trauma
Plasma and serum samples stored at -70C or colder
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Peter Biberthaler, MD/PHD
role: Principal Investigator
affiliation: Klinikum reichs der Isar
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Wounds and Injuries