<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/NCT03028376</url>
  </required_header>
  <id_info>
    <org_study_id>Protokol_v3_240816_PreTBI_II</org_study_id>
    <nct_id>NCT03028376</nct_id>
  </id_info>
  <brief_title>Biomarkers in Prehospital Prediction of Need for Neurosurgical Observation or Intervention in TBI Patients</brief_title>
  <acronym>PreTBI II</acronym>
  <official_title>S100B and Glial Fibrillary Acidic Protein (GFAP) in Prehospital Prediction of Need for Neurosurgical Observation or Intervention in Patients Suffering Moderate Traumatic Brain Injury (TBI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Central Denmark Region</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The PreTBI II study aims to investigate the diagnostic potential of prehospital S100B and&#xD;
      GFAP measurements in prediction of need for neurosurgical observation and/or intervention in&#xD;
      moderate TBI patients, to rule-in high-risk patients. Ultimately to select patients who will&#xD;
      benefit from neuro surgical expertise in specialized departments and thereby possibly better&#xD;
      patient outcome. Hopefully also minimize treatment delay, secure optimal resource consumption&#xD;
      and streamline patient courses by predicting the presence of neurotrauma.&#xD;
&#xD;
      Hypotheses:&#xD;
&#xD;
        1. A prehospital serum S100B level &gt; 0,10 microgram/L and expectedly above a certain and&#xD;
           currently unknown cut-off value indicates the need for neurosurgical observation and/or&#xD;
           intervention in moderate TBI patients.&#xD;
&#xD;
        2. A prehospital serum GFAP level above a certain and currently unknown cut-off value can&#xD;
           significantly predict a need for urgent neurosurgical observation and/or intervention in&#xD;
           moderate TBI patients.&#xD;
&#xD;
        3. Biomarker dynamics between prehospital and in-hospital biomarker values of S100B and&#xD;
           GFAP can significantly predict a need for urgent neurosurgical observation and/or&#xD;
           intervention.&#xD;
&#xD;
        4. Biomarker dynamics between prehospital and in-hospital biomarker values of S100B and&#xD;
           GFAP can significantly predict hospital course and outcome of patients with moderate&#xD;
           TBI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2017</start_date>
  <completion_date type="Actual">February 1, 2019</completion_date>
  <primary_completion_date type="Actual">February 1, 2019</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>Sensitivity of se-S100B in relation to a binary outcome measured by a yes/no question of &quot;need for neurosurgical observation and/or intervention&quot; pick yes/no</measure>
    <time_frame>in relation to event within 7 days of trauma</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Specificity of se-S100B in relation to a binary outcome measured by a yes/no question of &quot;need for neurosurgical observation and/or intervention&quot; pick yes/no</measure>
    <time_frame>in relation to event within 7 days of trauma</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive predictive value of se-S100B in relation to a binary outcome measured by a yes/no question of &quot;need for neurosurgical observation and/or intervention&quot; pick yes/no</measure>
    <time_frame>in relation to event within 7 days of trauma</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Negative predictive value of se-S100B in relation to a binary outcome measured by a yes/no question of &quot;need for neurosurgical observation and/or intervention&quot; pick yes/no</measure>
    <time_frame>in relation to event within 7 days of trauma</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of se-GFAP in relation to a binary outcome measured by a yes/no question of &quot;need for neurosurgical observation and/or intervention&quot; pick yes/no</measure>
    <time_frame>in relation to event within 7 days of trauma</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of se-GFAP in relation to a binary outcome measured by a yes/no question of &quot;need for neurosurgical observation and/or intervention&quot; pick yes/no</measure>
    <time_frame>in relation to event within 7 days of trauma</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive predictive value of se-GFAP in relation to a binary outcome measured by a yes/no question of &quot;need for neurosurgical observation and/or intervention&quot; pick yes/no</measure>
    <time_frame>in relation to event within 7 days of trauma</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Negative predictive value of se-GFAP in relation to a binary outcome measured by a yes/no question of &quot;need for neurosurgical observation and/or intervention&quot; pick yes/no</measure>
    <time_frame>in relation to event within 7 days of trauma</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Sensitivity of combined se-S100B and se-GFAP in relation to a binary outcome measured by by a yes/no question of &quot;immediate treatment &lt;24h/deferred treatment &lt;24h&quot; pick immediate/deferred</measure>
    <time_frame>in relation to event within 24 hours of trauma</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Specificity of combined se-S100B and se-GFAP in relation to a binary outcome measured by by a yes/no question of &quot;immediate treatment &lt;24h/deferred treatment &lt;24h&quot; pick immediate/deferred</measure>
    <time_frame>in relation to event within 24 hours of trauma</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Positive predictive value of combined se-S100B and se-GFAP in relation to a binary outcome measured by by a yes/no question of &quot;immediate treatment &lt;24h/deferred treatment &lt;24h&quot; pick immediate/deferred</measure>
    <time_frame>in relation to event within 24 hours of trauma</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Negative predictive value of combined se-S100B and se-GFAP in relation to a binary outcome measured by by a yes/no question of &quot;immediate treatment &lt;24h/deferred treatment &lt;24h&quot; pick immediate/deferred</measure>
    <time_frame>in relation to event within 24 hours of trauma</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Biomarker dynamics between prehospital and in-hospital se-S100B values in relation to a binary outcome measured by a yes/no question of &quot;need for neurosurgical observation and/or intervention&quot; pick yes/no</measure>
    <time_frame>in relation to event within 24 hours of trauma</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Biomarker dynamics between prehospital and in-hospital se-GFAP values in relation to a binary outcome measured by a yes/no question of &quot;need for neurosurgical observation and/or intervention&quot; pick yes/no</measure>
    <time_frame>in relation to event within 24 hours of trauma</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Biomarker dynamics between prehospital and in-hospital se-S100B values in relation to a binary outcome measured by a yes/no question of &quot;favorable neurological outcome&quot; pick favorable/unfavorable</measure>
    <time_frame>in relation to event within 1 year of trauma</time_frame>
    <description>Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as &quot;Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)</description>
  </other_outcome>
  <other_outcome>
    <measure>Biomarker dynamics between prehospital and in-hospital se-GFAP values in relation to a binary outcome measured by a yes/no question of &quot;favorable neurological outcome&quot; pick favorable/unfavorable</measure>
    <time_frame>in relation to event within 1 year of trauma</time_frame>
    <description>Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as &quot;Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)</description>
  </other_outcome>
  <other_outcome>
    <measure>Biomarker dynamics between prehospital and in-hospital combination of se-S100B, se-GFAP and se-NSE values in relation to a binary outcome measured by a yes/no question of &quot;favorable neurological outcome&quot; pick favorable/unfavorable</measure>
    <time_frame>in relation to event within 1 year of trauma</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">22</enrollment>
  <condition>Traumatic Brain INjury</condition>
  <arm_group>
    <arm_group_label>Moderate TBI patients</arm_group_label>
    <description>GCS 9-13</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood sampling</intervention_name>
    <description>Blood sampling from peripheral venous catheter routinely inserted in trauma patients during transportation</description>
    <arm_group_label>Moderate TBI patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All adult patients (≥18 years) suffering isolated head trauma and receiving an ambulance or&#xD;
        anaesthetist-staffed critical care team dispatched by the Prehospital Emergency Medical&#xD;
        Services (EMS) in the Central Denmark Region.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients presenting with Glasgow Coma Score (GCS) GCS 9-13 suffering relevant trauma&#xD;
             and displaying relevant clinical indices compatible with TBI as evaluated by EMS&#xD;
             staff. Patients are considered incompetent due to on-going alteration of mental state.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients &lt;18 years, GCS &lt;9, &gt;6 hours elapsed after trauma, unknown time of trauma,&#xD;
             multi trauma, known dementia, chronic psychosis or active central nervous system (CNS)&#xD;
             pathology.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Prehospital Emergency Medical Services, Central Denmark Region</name>
      <address>
        <city>Aarhus N</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>April 23, 2019</last_update_submitted>
  <last_update_submitted_qc>April 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>biomarker</keyword>
  <keyword>point-of-care analysis</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>
  </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/NCT03028376
org study id: Protokol_v3_240816_PreTBI_II
nct id: NCT03028376
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The PreTBI II study aims to investigate the diagnostic potential of prehospital S100B and
      GFAP measurements in prediction of need for neurosurgical observation and/or intervention in
      moderate TBI patients, to rule-in high-risk patients. Ultimately to select patients who will
      benefit from neuro surgical expertise in specialized departments and thereby possibly better
      patient outcome. Hopefully also minimize treatment delay, secure optimal resource consumption
      and streamline patient courses by predicting the presence of neurotrauma.

      Hypotheses:

        1. A prehospital serum S100B level > 0,10 microgram/L and expectedly above a certain and
           currently unknown cut-off value indicates the need for neurosurgical observation and/or
           intervention in moderate TBI patients.

        2. A prehospital serum GFAP level above a certain and currently unknown cut-off value can
           significantly predict a need for urgent neurosurgical observation and/or intervention in
           moderate TBI patients.

        3. Biomarker dynamics between prehospital and in-hospital biomarker values of S100B and
           GFAP can significantly predict a need for urgent neurosurgical observation and/or
           intervention.

        4. Biomarker dynamics between prehospital and in-hospital biomarker values of S100B and
           GFAP can significantly predict hospital course and outcome of patients with moderate
           TBI.
observational model: Cohort
time perspective: Prospective
measure: Sensitivity of se-S100B in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
time frame: in relation to event within 7 days of trauma
measure: Specificity of se-S100B in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
time frame: in relation to event within 7 days of trauma
measure: Positive predictive value of se-S100B in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
time frame: in relation to event within 7 days of trauma
measure: Negative predictive value of se-S100B in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
time frame: in relation to event within 7 days of trauma
measure: Sensitivity of se-GFAP in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
time frame: in relation to event within 7 days of trauma
measure: Specificity of se-GFAP in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
time frame: in relation to event within 7 days of trauma
measure: Positive predictive value of se-GFAP in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
time frame: in relation to event within 7 days of trauma
measure: Negative predictive value of se-GFAP in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
time frame: in relation to event within 7 days of trauma
measure: Sensitivity of combined se-S100B and se-GFAP in relation to a binary outcome measured by by a yes/no question of "immediate treatment <24h/deferred treatment <24h" pick immediate/deferred
time frame: in relation to event within 24 hours of trauma
measure: Specificity of combined se-S100B and se-GFAP in relation to a binary outcome measured by by a yes/no question of "immediate treatment <24h/deferred treatment <24h" pick immediate/deferred
time frame: in relation to event within 24 hours of trauma
measure: Positive predictive value of combined se-S100B and se-GFAP in relation to a binary outcome measured by by a yes/no question of "immediate treatment <24h/deferred treatment <24h" pick immediate/deferred
time frame: in relation to event within 24 hours of trauma
measure: Negative predictive value of combined se-S100B and se-GFAP in relation to a binary outcome measured by by a yes/no question of "immediate treatment <24h/deferred treatment <24h" pick immediate/deferred
time frame: in relation to event within 24 hours of trauma
measure: Biomarker dynamics between prehospital and in-hospital se-S100B values in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
time frame: in relation to event within 24 hours of trauma
measure: Biomarker dynamics between prehospital and in-hospital se-GFAP values in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
time frame: in relation to event within 24 hours of trauma
measure: Biomarker dynamics between prehospital and in-hospital se-S100B values in relation to a binary outcome measured by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
time frame: in relation to event within 1 year of trauma
description: Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)
measure: Biomarker dynamics between prehospital and in-hospital se-GFAP values in relation to a binary outcome measured by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
time frame: in relation to event within 1 year of trauma
description: Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)
measure: Biomarker dynamics between prehospital and in-hospital combination of se-S100B, se-GFAP and se-NSE values in relation to a binary outcome measured by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
time frame: in relation to event within 1 year of trauma
arm group label: Moderate TBI patients
description: GCS 9-13
intervention type: Other
intervention name: Blood sampling
description: Blood sampling from peripheral venous catheter routinely inserted in trauma patients during transportation
arm group label: Moderate TBI patients
Blood samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
sharing ipd: No