<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/NCT02229643</url>
  </required_header>
  <id_info>
    <org_study_id>658346</org_study_id>
    <nct_id>NCT02229643</nct_id>
  </id_info>
  <brief_title>Serum Neuroglobin and Nogo-A Concentrations in Acute Traumatic Brain Injury</brief_title>
  <official_title>Neuroglobin and Nogo-A as Biomarkers for the Prognosis of Closed Traumatic Brain Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai 6th People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai 6th People's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Neuroglobin has been described as a marker of traumatic brain injury. Nogo-A plays an&#xD;
      important role in mediating neuroanatomical plasticity and functional recovery following&#xD;
      traumatic brain injury. The investigators sought to examine the changes in serum neuroglobin&#xD;
      and Nogo-A concentrations in patients with traumatic brain injury during the initial 96-h&#xD;
      posttraumatic period and assessed the relation of neuroglobin and Nogo-A to Glasgow Coma&#xD;
      Score and prognosis of such patients with traumatic brain injury.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Glasgow Outcome Scale scores</measure>
    <time_frame>6 months</time_frame>
    <description>Glasgow Outcome Scale 1 = death; Glasgow Outcome Scale 2 = vegetative state; Glasgow Outcome Scale 3 = severe neurological deficit; Glasgow Outcome Scale 4 = mild neurological deficit and Glasgow Outcome Scale 5 = premorbid level of functioning or completely recovery. Unfavorable outcome was defined as a Glasgow Outcome Scale score of ≤ 3, and favorable outcome was defined as a Glasgow Outcome Scale score of &gt; 3.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">34</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Traumatic brain injury</arm_group_label>
    <description>Patients delivered within 4 h whose highest abbreviated injury score (AIS) was 3 or less (other than head injury) were considered to be isolated traumatic brain injury cases and were included in this study.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The patient group comprised 21 male and 13 female. Their age ranged from 19 to 68 years,&#xD;
        with mean age of 45.1 years. The mechanisms of trauma included motor vehicle collisions,&#xD;
        falls, heavy strikes (patients who were hit by heavy objects such as bricks, sticks, or&#xD;
        falling objects) and assaults. Types of lesions, as evidenced by radiologic and neurologic&#xD;
        symptoms or signs, included cerebral contusions/lacerations, intracranial hematomas, brain&#xD;
        stem injury and diffuse axonal injury.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who suffered head trauma and whose highest abbreviated injury score (AIS) was&#xD;
             3 or less (other than head injury)&#xD;
&#xD;
          -  Patients who delivered to hospital within 4 h&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who suffered open injuries&#xD;
&#xD;
          -  Patients who had existing prior neurological disease&#xD;
&#xD;
          -  Patients whose serial serum samples could not be obtained&#xD;
&#xD;
          -  Patients less than 18 years of age&#xD;
&#xD;
          -  Patients who suffered severe life-threatening injury to organs other than the brain&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lixia Xue, M.D., Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Shanghai 6th People's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Sixth People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>200233</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <last_update_submitted>August 8, 2020</last_update_submitted>
  <last_update_submitted_qc>August 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai 6th People's Hospital</investigator_affiliation>
    <investigator_full_name>Hao Chen</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>Traumatic brain injury</keyword>
  <keyword>Neuroglobin</keyword>
  <keyword>Nogo-A</keyword>
  <keyword>Prognosis</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/NCT02229643
org study id: 658346
nct id: NCT02229643
lead sponsor: 
has dmc: No
Neuroglobin has been described as a marker of traumatic brain injury. Nogo-A plays an
      important role in mediating neuroanatomical plasticity and functional recovery following
      traumatic brain injury. The investigators sought to examine the changes in serum neuroglobin
      and Nogo-A concentrations in patients with traumatic brain injury during the initial 96-h
      posttraumatic period and assessed the relation of neuroglobin and Nogo-A to Glasgow Coma
      Score and prognosis of such patients with traumatic brain injury.
observational model: Case-Only
time perspective: Prospective
measure: Glasgow Outcome Scale scores
time frame: 6 months
description: Glasgow Outcome Scale 1 = death; Glasgow Outcome Scale 2 = vegetative state; Glasgow Outcome Scale 3 = severe neurological deficit; Glasgow Outcome Scale 4 = mild neurological deficit and Glasgow Outcome Scale 5 = premorbid level of functioning or completely recovery. Unfavorable outcome was defined as a Glasgow Outcome Scale score of ≤ 3, and favorable outcome was defined as a Glasgow Outcome Scale score of > 3.
arm group label: Traumatic brain injury
description: Patients delivered within 4 h whose highest abbreviated injury score (AIS) was 3 or less (other than head injury) were considered to be isolated traumatic brain injury cases and were included in this study.
Serum samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Lixia Xue, M.D., Ph.D.
role: Study Director
affiliation: Shanghai 6th People's Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai 6th People's Hospital
investigator full name: Hao Chen
investigator title: Doctor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Wounds and Injuries