<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/NCT03020849</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL17_0015</org_study_id>
    <nct_id>NCT03020849</nct_id>
  </id_info>
  <brief_title>Predictors of Hypofibrinogenemia in Severe Trauma</brief_title>
  <official_title>Can we Define a Clinical Score for Predicting of Hypofibrinogenemia in Severe Trauma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this retrospective and prospective study, the aim is to determine a score for predicting a&#xD;
      fibrinogen &lt;1.5g/L (corresponding to European threshold of Directors recommendations of&#xD;
      fibrinogen concentrates)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>rate of fibrinogen in blood sample at hospitalisation</measure>
    <time_frame>day 0 (at hospitalisation)</time_frame>
    <description>This fibrinogen rate is correlated to pre-hospital and admission clinical parameters (trauma type, physiologic status, treatments administered, biologic checkup) to predict fibrinogenemia at hospitalisation</description>
  </primary_outcome>
  <enrollment type="Actual">1038</enrollment>
  <condition>Severe Trauma</condition>
  <eligibility>
    <study_pop>
      <textblock>
        severe trauma&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt; 18&#xD;
&#xD;
          -  severe trauma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt;18&#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>HEH - Hospices Civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHLS, Hospices Civils de Lyon</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>July 27, 2017</last_update_submitted>
  <last_update_submitted_qc>July 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hypofibrinogenemia</keyword>
  <keyword>prediction score</keyword>
  <keyword>severe trauma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03020849
org study id: 69HCL17_0015
nct id: NCT03020849
lead sponsor: 
has dmc: No
In this retrospective and prospective study, the aim is to determine a score for predicting a
      fibrinogen <1.5g/L (corresponding to European threshold of Directors recommendations of
      fibrinogen concentrates)
observational model: Cohort
time perspective: Prospective
measure: rate of fibrinogen in blood sample at hospitalisation
time frame: day 0 (at hospitalisation)
description: This fibrinogen rate is correlated to pre-hospital and admission clinical parameters (trauma type, physiologic status, treatments administered, biologic checkup) to predict fibrinogenemia at hospitalisation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Wounds and Injuries
sharing ipd: No