<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/NCT04428970</url>
  </required_header>
  <id_info>
    <org_study_id>2086/2019</org_study_id>
    <nct_id>NCT04428970</nct_id>
  </id_info>
  <brief_title>Intracranial Pressure (ICP) Monitoring Following Traumatic Brain Injury (TBI)</brief_title>
  <official_title>Intracranial Pressure Monitoring Following Traumatic Brain Injury - Evaluation of Indications, Complications, and Significance of Follow-up Imaging.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this retrospective cohort study is to evaluate complications rates, indications,&#xD;
      and the utility of follow-up imaging studies of ICP measurement in severe TBI patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2007</start_date>
  <completion_date type="Actual">January 31, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Complications</measure>
    <time_frame>up to 30 days</time_frame>
    <description>Intervention-related complications</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical outcome</measure>
    <time_frame>up to 30 days</time_frame>
    <description>Outcome at discharge measured by the Glasgow Outcome Scale (GOS), range 1(death) - 5 (good recovery)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">214</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>TBI patients with ICP monitoring</arm_group_label>
    <description>Patients with severe TBI (GCS&lt;9 on arrival) receiving invasive ICP monitoring</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Invasive ICP monitoring</intervention_name>
    <description>Insertion of a parenchymal pressure measuring probe</description>
    <arm_group_label>TBI patients with ICP monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients transferred to our department after severe TBI who had received invasive ICP&#xD;
        monitoring will be included in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Severe Traumatic Brain Injury (GCS&lt;9 on arrival)&#xD;
&#xD;
          -  Implantation of invasive intracranial parenchymal ICP monitoring&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  incomplete data records&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical Universtiy of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>A-1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>January 23, 2021</last_update_submitted>
  <last_update_submitted_qc>January 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Thomas Haider</investigator_full_name>
    <investigator_title>M.D., Ph.D.</investigator_title>
  </responsible_party>
  <keyword>Intracranial pressure monitoring</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04428970
org study id: 2086/2019
nct id: NCT04428970
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim of this retrospective cohort study is to evaluate complications rates, indications,
      and the utility of follow-up imaging studies of ICP measurement in severe TBI patients.
observational model: Cohort
time perspective: Retrospective
measure: Complications
time frame: up to 30 days
description: Intervention-related complications
measure: Clinical outcome
time frame: up to 30 days
description: Outcome at discharge measured by the Glasgow Outcome Scale (GOS), range 1(death) - 5 (good recovery)
arm group label: TBI patients with ICP monitoring
description: Patients with severe TBI (GCS<9 on arrival) receiving invasive ICP monitoring
intervention type: Procedure
intervention name: Invasive ICP monitoring
description: Insertion of a parenchymal pressure measuring probe
arm group label: TBI patients with ICP monitoring
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Thomas Haider
investigator title: M.D., Ph.D.
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Wounds and Injuries
sharing ipd: No