<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/NCT03293420</url>
  </required_header>
  <id_info>
    <org_study_id>LITTEL-GIRARD 2016</org_study_id>
    <nct_id>NCT03293420</nct_id>
  </id_info>
  <brief_title>Retrospective Analysis of a Population of Patients With With Severe Traumatic Head Injury and Woken Early</brief_title>
  <acronym>PRECOCE TC</acronym>
  <official_title>Retrospective Analysis of a Population of Patients With With Severe Traumatic Head Injury and Woken Early</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Observational retrospective study that included all patients meeting the inclusion criteria&#xD;
      from 1st January 2014 to 31st December 2015.&#xD;
&#xD;
      The objective of the study is to describe and compare two populations of patients with severe&#xD;
      traumatic head injury arriving under sedation in the Department in whom the sedation was not&#xD;
      continued.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Motor score</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <enrollment type="Actual">61</enrollment>
  <condition>Traumatic Head Injury</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with traumatic head injury&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patients with traumatic head injuring arriving in the Neurosurgery and Traumatologic&#xD;
        Intensive Care Unit under sedation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Brain death within the 48h following admission,&#xD;
&#xD;
          -  Stroke leading to the traumatic head injury,&#xD;
&#xD;
          -  Death within the 24h following admission,&#xD;
&#xD;
          -  Patients not under sedation on admission to the unit,&#xD;
&#xD;
          -  Non-sedated patients transferred directly to the operating theatre&#xD;
&#xD;
          -  Traumatic brain injury in patients presenting chronic sub-dural haematoma,&#xD;
&#xD;
          -  Continued sedation (&gt; 15h) in the ICU.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>CHU Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>September 25, 2017</last_update_submitted>
  <last_update_submitted_qc>September 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2017</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>Craniocerebral Trauma</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/NCT03293420
org study id: LITTEL-GIRARD 2016
nct id: NCT03293420
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Observational retrospective study that included all patients meeting the inclusion criteria
      from 1st January 2014 to 31st December 2015.

      The objective of the study is to describe and compare two populations of patients with severe
      traumatic head injury arriving under sedation in the Department in whom the sedation was not
      continued.
observational model: Other
time perspective: Retrospective
measure: Motor score
time frame: At baseline
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: France
responsible party type: Sponsor
mesh term: Craniocerebral Trauma
mesh term: Wounds and Injuries