<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/NCT03249129</url>
  </required_header>
  <id_info>
    <org_study_id>2016_42</org_study_id>
    <secondary_id>2017-A00661-52</secondary_id>
    <nct_id>NCT03249129</nct_id>
  </id_info>
  <brief_title>Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma</brief_title>
  <acronym>TRAME</acronym>
  <official_title>Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</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>
      The purpose of the study is to detect the presence of autoantibodies and autoantigens in&#xD;
      cerebrospinal fluid early (&lt;48 hours) following spinal cord trauma.&#xD;
&#xD;
      The study also aims to define the central or peripheral origin of autoantibodies by looking&#xD;
      for their simultaneous presence at the blood level and to evaluate the prognostic value of&#xD;
      the presence of autoantibodies within the cerebrospinal fluid, as well as on the initial&#xD;
      clinical severity than on the recovery potential.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    sponsor decision&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 2018</start_date>
  <completion_date type="Anticipated">April 2021</completion_date>
  <primary_completion_date type="Anticipated">April 2021</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>Level of anti glial fibrillary acid protein antibodies</measure>
    <time_frame>The sampling is performed at the initial stage, i.e. within 48 hours after trauma. The time between trauma and sampling is specified and measured in hours.</time_frame>
    <description>Anti glial fibrillary acid protein antibodies measured into the cerebrospinal fluid</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood level of anti glial fibrillary acid protein antibodies</measure>
    <time_frame>The sampling is performed at the initial stage, i.e. within 48 hours after trauma. The time between trauma and sampling is specified and measured in hours.</time_frame>
    <description>Anti glial fibrillary acid protein antibodies measured into the blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of Neurological Impairment</measure>
    <time_frame>in the initial phase, at day 7, at 1 months, 3 months, 6 months and 1 year</time_frame>
    <description>Measured using the American Society Injury Association score</description>
  </secondary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Bone Marrow Failure</condition>
  <condition>Trauma</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients over 18 years old with spinal cord trauma, for whom CSF sampling may be&#xD;
        performed safely within the first 48 hours.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with spinal cord injury dating back less than 48 hours&#xD;
&#xD;
          2. Men or women over 18 years of age&#xD;
&#xD;
          3. Patients benefiting from social protection&#xD;
&#xD;
          4. Surgery performed within 48 hours of the trauma&#xD;
&#xD;
          5. Informed and signed consent by the patient or trusted person&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contra-indication to ensure surgical decompression within the first 48 hours following&#xD;
             the trauma&#xD;
&#xD;
          2. Coagulation disorders or any condition that may make the lumbar puncture risky (eg,&#xD;
             history of lumbar surgery)&#xD;
&#xD;
          3. Severe cranial trauma associated&#xD;
&#xD;
          4. History of autoimmune pathology&#xD;
&#xD;
          5. Immunosuppressive therapy or long-term corticosteroid therapy&#xD;
&#xD;
          6. Patients unable to comply with protocol requirements&#xD;
&#xD;
          7. Person benefiting from legal protection (guardianship / curator)&#xD;
&#xD;
          8. Person deprived of liberty&#xD;
&#xD;
          9. Patient unable to express consent&#xD;
&#xD;
         10. Pregnant women&#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_official>
    <last_name>Fahed Zairi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>December 3, 2019</last_update_submitted>
  <last_update_submitted_qc>December 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Trauma</keyword>
  <keyword>spinal cord</keyword>
  <keyword>autoimmunity</keyword>
  <keyword>antibody</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Bone Marrow Failure Disorders</mesh_term>
    <mesh_term>Pancytopenia</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/NCT03249129
org study id: 2016_42
secondary id: 2017-A00661-52
nct id: NCT03249129
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to detect the presence of autoantibodies and autoantigens in
      cerebrospinal fluid early (<48 hours) following spinal cord trauma.

      The study also aims to define the central or peripheral origin of autoantibodies by looking
      for their simultaneous presence at the blood level and to evaluate the prognostic value of
      the presence of autoantibodies within the cerebrospinal fluid, as well as on the initial
      clinical severity than on the recovery potential.
observational model: Cohort
time perspective: Prospective
measure: Level of anti glial fibrillary acid protein antibodies
time frame: The sampling is performed at the initial stage, i.e. within 48 hours after trauma. The time between trauma and sampling is specified and measured in hours.
description: Anti glial fibrillary acid protein antibodies measured into the cerebrospinal fluid
measure: Blood level of anti glial fibrillary acid protein antibodies
time frame: The sampling is performed at the initial stage, i.e. within 48 hours after trauma. The time between trauma and sampling is specified and measured in hours.
description: Anti glial fibrillary acid protein antibodies measured into the blood
measure: Severity of Neurological Impairment
time frame: in the initial phase, at day 7, at 1 months, 3 months, 6 months and 1 year
description: Measured using the American Society Injury Association score
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fahed Zairi, MD
role: Principal Investigator
affiliation: University Hospital, Lille
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
mesh term: Bone Marrow Failure Disorders
mesh term: Pancytopenia
mesh term: Wounds and Injuries
sharing ipd: No