<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/NCT01688869</url>
  </required_header>
  <id_info>
    <org_study_id>04-12-03A</org_study_id>
    <nct_id>NCT01688869</nct_id>
  </id_info>
  <brief_title>Mild Traumatic Brain Injury Registry</brief_title>
  <acronym>mTBI</acronym>
  <official_title>Mild Traumatic Brain Injury Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to gather information about patients with mild traumatic brain&#xD;
      injury in order to develop guidelines for evaluation and treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Mild Traumatic Brain Injury Registry is a prospective study which includes patients who&#xD;
      have been seen in the CMC ED with a diagnosis of mild brain injury or concussion and a&#xD;
      negative CT scan. The investigators will be collecting blood samples, and administering&#xD;
      cognitive and balance tests. The investigators will also be following symptoms and cognition&#xD;
      throughout the first year to help define typical recovery, and guide prognosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>To determine which biomarkers and/or clinical variables correlate with long term symptoms of mild traumatic brain injury.</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Brain Injury, Traumatic</condition>
  <arm_group>
    <arm_group_label>Mild TBI</arm_group_label>
    <description>Patients who have been diagnosed with a mild brain injury.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples will be obtained in the emergency room and processed for future analysis.&#xD;
      Depending on the blood volume obtained, up to two citrate, two EDTA, and one Paxgene tube&#xD;
      will be collected.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are seen in the CMC emergency department who have a clearly defined history of&#xD;
        traumatic brain injury that produced at least transient alteration in consciousness, or&#xD;
        change in mood, together with one or more persistent symptom lasting longer than one hour&#xD;
        after impact. Symptoms can include head pain, nausea, dizziness, disequilibrium, confusion,&#xD;
        amnesia, or irritability. All patients must be awake and alert (GCS 13 to 15), and must be&#xD;
        enrolled within 72 hours of the injury.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must have defined history of CHI (closed head injury) which produced an altered state&#xD;
             of consciousness or mood&#xD;
&#xD;
          -  Must be awake and alert (Glasgow Coma Scale 13-15)&#xD;
&#xD;
          -  Must be enrolled within 72 hours of injury&#xD;
&#xD;
          -  Must have CT or MRI neuroimaging performed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes Mellitus with severe complications&#xD;
&#xD;
          -  Intoxication at time of enrollment&#xD;
&#xD;
          -  Major psychiatric disorder that is poorly controlled&#xD;
&#xD;
          -  Prior stroke&#xD;
&#xD;
          -  History of Social Security defined &quot;disability&#xD;
&#xD;
          -  Uncontrolled Seizure Disorder&#xD;
&#xD;
          -  Incarceration or arrest&#xD;
&#xD;
          -  Concurrent Injury requiring hospitalization&#xD;
&#xD;
          -  Use of anticoagulant drugs&#xD;
&#xD;
          -  Any condition the investigator deems as inappropriate for patient enrollment&#xD;
&#xD;
          -  Personality disorder&#xD;
&#xD;
          -  Heart, liver or kidney failure defined using common clinical practice guidelines&#xD;
&#xD;
          -  Baseline cognitive impairment&#xD;
&#xD;
          -  Homelessness&#xD;
&#xD;
          -  TBI associated with interpersonal violence&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Long bone fracture requiring surgical stabilization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lori M Grafton, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael A Gibbs, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Carolinas Medical Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <last_update_submitted>April 19, 2022</last_update_submitted>
  <last_update_submitted_qc>April 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>brain concussion</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>Brain Concussion</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/NCT01688869
org study id: 04-12-03A
nct id: NCT01688869
lead sponsor: 
has dmc: Yes
The purpose of the study is to gather information about patients with mild traumatic brain
      injury in order to develop guidelines for evaluation and treatment.
The Mild Traumatic Brain Injury Registry is a prospective study which includes patients who
      have been seen in the CMC ED with a diagnosis of mild brain injury or concussion and a
      negative CT scan. The investigators will be collecting blood samples, and administering
      cognitive and balance tests. The investigators will also be following symptoms and cognition
      throughout the first year to help define typical recovery, and guide prognosis.
observational model: Cohort
time perspective: Prospective
measure: To determine which biomarkers and/or clinical variables correlate with long term symptoms of mild traumatic brain injury.
time frame: 6 months
arm group label: Mild TBI
description: Patients who have been diagnosed with a mild brain injury.
Blood samples will be obtained in the emergency room and processed for future analysis.
      Depending on the blood volume obtained, up to two citrate, two EDTA, and one Paxgene tube
      will be collected.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 60 Years
healthy volunteers: No
last name: Lori M Grafton, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
last name: Michael A Gibbs, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Brain Concussion
mesh term: Wounds and Injuries