<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/NCT03780062</url>
  </required_header>
  <id_info>
    <org_study_id>PETEChIA</org_study_id>
    <nct_id>NCT03780062</nct_id>
  </id_info>
  <brief_title>Interest of S100B Protein for Patient Victim of Minor Traumatic Brain Injury and Treated by Antiplatelet</brief_title>
  <acronym>PETEChIA</acronym>
  <official_title>Interest of S100B Protein for Patient Victim of Minor Traumatic Brain Injury and Treated by Antiplatelet</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poitiers University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poitiers University Hospital</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>
      All the patients admitted in emergency department for minor traumatized cranial, with&#xD;
      antiplatelet therapy, can be included, after checked inclusion and non inclusions criterias.&#xD;
      If they are agree, a blood sample for the dosage of S100b will be done.&#xD;
&#xD;
      No other modification of the medical care, all patients will have tomodensitometria,&#xD;
      according with recommendations. The aim of the study is to validate the negative predictive&#xD;
      value of S100b in this population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 17, 2019</start_date>
  <completion_date type="Anticipated">March 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Brain scanner Detection of a cerebral lesion requiring a surgery or medical intervention or an hospitalisation for a patient who have serum level of S100B protein with the treshold of 0.105 μg/L</measure>
    <time_frame>3 hours</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">720</enrollment>
  <condition>Minor Traumatic Brain Injury</condition>
  <condition>Treatment by Antiplatelet</condition>
  <arm_group>
    <arm_group_label>S100B protein dosing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>S100B protein dosing</intervention_name>
    <description>Patients under antiplatelet therapy and who have a minor traumatic brain injury will have a blood samples with protein S100B dosage on arrival to the emergency room and after they will have a brain scanner between 4 and 8 hours after the trauma to analyse the negative predictive value with a treshold of 0.105 μg/L</description>
    <arm_group_label>S100B protein dosing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 Years old&#xD;
&#xD;
          -  Minor traumatic brain injury measured by a Glasgow score between 13 and 15&#xD;
&#xD;
          -  Antiplatelet agent therapy&#xD;
&#xD;
          -  Free subject without tutorship or curatorship&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years old&#xD;
&#xD;
          -  Glasgow score &lt;13&#xD;
&#xD;
          -  Traumatic brain injury older than 6 hours&#xD;
&#xD;
          -  Patient without any social security system&#xD;
&#xD;
          -  Patient with renforced protection (tutorship, curatorship, …)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jérémy GUENEZAN, Hospital Practitioner</last_name>
    <phone>0549444444</phone>
    <phone_ext>46991</phone_ext>
    <email>jeremy.guenezan@chu-poitiers.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU of MONTPELLIER</name>
      <address>
        <city>Montpellier</city>
        <zip>34090</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mustapha SEBBANE, Professor</last_name>
      <phone>0467336733</phone>
      <email>m-sebbane@chu-montpellier.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU of NICE</name>
      <address>
        <city>Nice</city>
        <zip>06003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jacques LEVRAUT, Professor</last_name>
      <phone>0492033242</phone>
      <email>levraut.j@chu-nice.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>La Pité Salpêtrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne Laure PAQUET, Hospital Practitionner</last_name>
      <phone>0142176006</phone>
      <email>annelaure.paquet@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU of POITIERS</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jérémy GUENEZAN, Hospital Practitionner</last_name>
      <phone>0549444444</phone>
      <phone_ext>46991</phone_ext>
      <email>jeremy.guenezan@chu-poitiers.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>August 18, 2022</last_update_submitted>
  <last_update_submitted_qc>August 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>S100B protein</keyword>
  <keyword>minor traumatic brain injuries</keyword>
  <keyword>antiplatelet therapy</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/NCT03780062
org study id: PETEChIA
nct id: NCT03780062
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
All the patients admitted in emergency department for minor traumatized cranial, with
      antiplatelet therapy, can be included, after checked inclusion and non inclusions criterias.
      If they are agree, a blood sample for the dosage of S100b will be done.

      No other modification of the medical care, all patients will have tomodensitometria,
      according with recommendations. The aim of the study is to validate the negative predictive
      value of S100b in this population.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Brain scanner Detection of a cerebral lesion requiring a surgery or medical intervention or an hospitalisation for a patient who have serum level of S100B protein with the treshold of 0.105 μg/L
time frame: 3 hours
arm group label: S100B protein dosing
arm group type: Experimental
intervention type: Biological
intervention name: S100B protein dosing
description: Patients under antiplatelet therapy and who have a minor traumatic brain injury will have a blood samples with protein S100B dosage on arrival to the emergency room and after they will have a brain scanner between 4 and 8 hours after the trauma to analyse the negative predictive value with a treshold of 0.105 μg/L
arm group label: S100B protein dosing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jérémy GUENEZAN, Hospital Practitioner
phone: 0549444444
phone ext: 46991
email: jeremy.guenezan@chu-poitiers.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Wounds and Injuries