<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/NCT04446325</url>
  </required_header>
  <id_info>
    <org_study_id>29BRC19.0236</org_study_id>
    <nct_id>NCT04446325</nct_id>
  </id_info>
  <brief_title>Venous Disease Thromboembolic and Amyotrophic Lateral Sclerosis</brief_title>
  <acronym>TESLA</acronym>
  <official_title>Venous Disease Thromboembolic and Amyotrophic Lateral Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</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>
      Venous thrombo-embolic (VTE) rates could be high in patients with amyotrophic lateral&#xD;
      sclerosis (ALS). Indeed, the rate of VTE in this specific population could be 7-fold higher&#xD;
      in this population. Predictiv factors of VTE in patients with ALS are mobility reduction and&#xD;
      neurological paralysis. However, to our knowledge, medical littérature is poor concerning VTE&#xD;
      and ALS association.&#xD;
&#xD;
      Our first aim is to define annual rate of VTE in ALS population.Then we aim to identify&#xD;
      predictiv factors of VTE in this specific population. The studied population is Brest&#xD;
      universitary hospital cohort of ALS patient included between 2000 and 2019.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Actual">May 1, 2020</completion_date>
  <primary_completion_date type="Actual">March 1, 2020</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>Number of venous thrombo-embolic eventsrate per year in amyotrophic lateral sclerosis patients followed between 2000 and 2019 in Brest universitary hospital</measure>
    <time_frame>19 years</time_frame>
    <description>pulmonary embolism and deep venous thrombosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of predictiv factors of venous thrombo-embolism events in amyotrophic lateral sclerosis population followed in Brest universitary hospital between 2000 and 2019</measure>
    <time_frame>19 years</time_frame>
    <description>immobilization, impairment of respiratory function,, mecanical ventilation, denutrition, artificial nutrition</description>
  </secondary_outcome>
  <enrollment type="Actual">227</enrollment>
  <condition>Lateral Amyotrophic Sclerosis</condition>
  <condition>Venous Thrombo-embolic Desease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients with amyotrophic lateral sclerosis defined by revised El Escorial score criteria&#xD;
        followed in competence centre of brest universitary hospital during 2000 to 2019&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with amyotrophic lateral sclerosis defined by revised El Escorial score&#xD;
             criteria followed in competence centre of Brest Universitary Hospital during 2000 to&#xD;
             2019&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no consent&#xD;
&#xD;
          -  other neuro-degenerativ diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHRU de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>September 10, 2020</last_update_submitted>
  <last_update_submitted_qc>September 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>lateral amyotrophic sclerosis</keyword>
  <keyword>venous thrombo-embolic desase</keyword>
  <keyword>pulmonary embolism</keyword>
  <keyword>deep venous thrombosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Motor Neuron Disease</mesh_term>
    <mesh_term>Amyotrophic Lateral Sclerosis</mesh_term>
    <mesh_term>Thromboembolism</mesh_term>
    <mesh_term>Sclerosis</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/NCT04446325
org study id: 29BRC19.0236
nct id: NCT04446325
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Venous thrombo-embolic (VTE) rates could be high in patients with amyotrophic lateral
      sclerosis (ALS). Indeed, the rate of VTE in this specific population could be 7-fold higher
      in this population. Predictiv factors of VTE in patients with ALS are mobility reduction and
      neurological paralysis. However, to our knowledge, medical littérature is poor concerning VTE
      and ALS association.

      Our first aim is to define annual rate of VTE in ALS population.Then we aim to identify
      predictiv factors of VTE in this specific population. The studied population is Brest
      universitary hospital cohort of ALS patient included between 2000 and 2019.
observational model: Cohort
time perspective: Retrospective
measure: Number of venous thrombo-embolic eventsrate per year in amyotrophic lateral sclerosis patients followed between 2000 and 2019 in Brest universitary hospital
time frame: 19 years
description: pulmonary embolism and deep venous thrombosis
measure: Number of predictiv factors of venous thrombo-embolism events in amyotrophic lateral sclerosis population followed in Brest universitary hospital between 2000 and 2019
time frame: 19 years
description: immobilization, impairment of respiratory function,, mecanical ventilation, denutrition, artificial nutrition
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Motor Neuron Disease
mesh term: Amyotrophic Lateral Sclerosis
mesh term: Thromboembolism
mesh term: Sclerosis