<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/NCT03810222</url>
  </required_header>
  <id_info>
    <org_study_id>TBI-PRO</org_study_id>
    <nct_id>NCT03810222</nct_id>
  </id_info>
  <brief_title>A Prospective Outcome Study in Patients With Moderate to Severe Traumatic Brain Injury</brief_title>
  <acronym>TBI-PRO</acronym>
  <official_title>A Prospective Outcome Study in Patients With Moderate to Severe Traumatic Brain Injury in Bergamo Area (Italy)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione per la Ricerca Ospedale Maggiore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondazione per la Ricerca Ospedale Maggiore</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>
      Traumatic brain injury (TBI) is the leading cause of death, disability and cognitive&#xD;
      impairment in young people worldwide. The majority of the traumatic deaths in developed&#xD;
      countries results directly from lesions in the central nervous system. Furthermore, due to&#xD;
      the persistence of disabling effects of TBI for many years, personal and public costs of&#xD;
      supporting survivors have to be taken in consideration.&#xD;
&#xD;
      Many patients rescued by ICU treatment may have been severely disabled or vegetative because&#xD;
      of trauma. These data suggest that, despite improvement in medical and surgical treatments,&#xD;
      other factors related to trauma itself and to patient's condition could have an impact on the&#xD;
      final outcome.&#xD;
&#xD;
      Aim of the TBI-PRO project is to collect high quality clinical and epidemiological data and&#xD;
      to describe the outcome of moderate-to-severe TBI in a local contest (Bergamo area, Italy).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients admitted to the ICU with a diagnosis of moderate-to-severe TBI, with or without&#xD;
      polytrauma, are recruited. Bergamo hospital is the main Trauma Centre (Level I) and the only&#xD;
      referring neurosurgical center within a population of 1.2 million inhabitants of Bergamo&#xD;
      area. This hospital is also a Regional Pediatric Trauma Centre.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2017</start_date>
  <completion_date type="Actual">January 31, 2020</completion_date>
  <primary_completion_date type="Actual">January 31, 2020</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>Glasgow Outcome Scale - Extended (GOSE)</measure>
    <time_frame>12 Months Post-Injury</time_frame>
    <description>The global functional outcome at 12 months is assessed using the Glasgow Outcome Scale-Extended (GOS-E), obtained through structured interview. The GOS-E is a well-validated, widely employed measure of disability based on information on independence, employability, and social/community participation. The baseline function prior to injury is assessed to ensure that the deficit can be attributed to the event. GOS-E is dichotomized into favorable (a score of 5 to 8, Moderate Disability is defined by a score of 5-6) and unfavorable (a score of 1 to 4, Dead is defined by a score of 1).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>6-Month Outcome</measure>
    <time_frame>6 Months Post-Injury</time_frame>
    <description>The functional outcome at 6 months is assessed using the GOS-E, neuroradiological findings (MRI Brain scan or CT) obtained within a 6 month-period post-injury are also considered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropsychological evaluation</measure>
    <time_frame>12 Months Post-Injury</time_frame>
    <description>A neuropsychological test battery is designed to evaluate the cognitive domains commonly affected in survivors of moderate to severe TBI.</description>
  </secondary_outcome>
  <enrollment type="Actual">225</enrollment>
  <condition>Brain Injuries, Traumatic</condition>
  <condition>Brain Injury Traumatic Moderate</condition>
  <condition>Brain Injury Traumatic Severe</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>N/A (Observational Study)</intervention_name>
    <description>This is an observational study and does not include interventions. Exposure is TBI.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to the ICU with a diagnosis of moderate (Glasgow Coma Scale, GCS 9-13) or&#xD;
        severe TBI (GCS 3-8), with or without associated polytrauma. Patients transferred from&#xD;
        other hospitals within the first 24h are included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  admission to ICU&#xD;
&#xD;
          -  diagnosis of moderate-to-severe TBI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who died in the first couple of hours after hospital admission are not included.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>PAOLO GRITTI, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ASST- Papa Giovanni XXIII</affiliation>
  </overall_official>
  <overall_official>
    <last_name>FRANCESCO BIROLI, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Fondazione per la Ricerca Ospedale di Bergamo (FROM)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ASST- Papa Giovanni XXIII</name>
      <address>
        <city>Bergamo</city>
        <zip>24127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>February 22, 2021</last_update_submitted>
  <last_update_submitted_qc>February 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TBI moderate, TBI severe, GOSE</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/NCT03810222
org study id: TBI-PRO
nct id: NCT03810222
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Traumatic brain injury (TBI) is the leading cause of death, disability and cognitive
      impairment in young people worldwide. The majority of the traumatic deaths in developed
      countries results directly from lesions in the central nervous system. Furthermore, due to
      the persistence of disabling effects of TBI for many years, personal and public costs of
      supporting survivors have to be taken in consideration.

      Many patients rescued by ICU treatment may have been severely disabled or vegetative because
      of trauma. These data suggest that, despite improvement in medical and surgical treatments,
      other factors related to trauma itself and to patient's condition could have an impact on the
      final outcome.

      Aim of the TBI-PRO project is to collect high quality clinical and epidemiological data and
      to describe the outcome of moderate-to-severe TBI in a local contest (Bergamo area, Italy).
All patients admitted to the ICU with a diagnosis of moderate-to-severe TBI, with or without
      polytrauma, are recruited. Bergamo hospital is the main Trauma Centre (Level I) and the only
      referring neurosurgical center within a population of 1.2 million inhabitants of Bergamo
      area. This hospital is also a Regional Pediatric Trauma Centre.
observational model: Cohort
time perspective: Prospective
measure: Glasgow Outcome Scale - Extended (GOSE)
time frame: 12 Months Post-Injury
description: The global functional outcome at 12 months is assessed using the Glasgow Outcome Scale-Extended (GOS-E), obtained through structured interview. The GOS-E is a well-validated, widely employed measure of disability based on information on independence, employability, and social/community participation. The baseline function prior to injury is assessed to ensure that the deficit can be attributed to the event. GOS-E is dichotomized into favorable (a score of 5 to 8, Moderate Disability is defined by a score of 5-6) and unfavorable (a score of 1 to 4, Dead is defined by a score of 1).
measure: 6-Month Outcome
time frame: 6 Months Post-Injury
description: The functional outcome at 6 months is assessed using the GOS-E, neuroradiological findings (MRI Brain scan or CT) obtained within a 6 month-period post-injury are also considered.
measure: Neuropsychological evaluation
time frame: 12 Months Post-Injury
description: A neuropsychological test battery is designed to evaluate the cognitive domains commonly affected in survivors of moderate to severe TBI.
intervention type: Other
intervention name: N/A (Observational Study)
description: This is an observational study and does not include interventions. Exposure is TBI.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: PAOLO GRITTI, MD
role: Principal Investigator
affiliation: ASST- Papa Giovanni XXIII
last name: FRANCESCO BIROLI, MD
role: Study Chair
affiliation: Fondazione per la Ricerca Ospedale di Bergamo (FROM)
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Wounds and Injuries