<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/NCT03248596</url>
  </required_header>
  <id_info>
    <org_study_id>35RC15_3023_ECMO PFA-100</org_study_id>
    <nct_id>NCT03248596</nct_id>
  </id_info>
  <brief_title>Interest in Evaluating Primary Hemostasis in Patients With Veno-venous Extracorporeal Membrane Oxygenation (ECMO)</brief_title>
  <acronym>ECMO PFA-100</acronym>
  <official_title>Interest in Evaluating Primary Hemostasis in Patients With Veno-venous Extracorporeal Membrane Oxygenation (ECMO)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</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 aim of the study is a better understanding of hemorrhagic events causes in patients with&#xD;
      ECMO, prevent them and decrease the number of transfusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The most frequent complication during ECMO is hemorrhage especially as a curative&#xD;
      anticoagulant treatment is necessary. The primary hemostasis is also affected with a von&#xD;
      Willebrand disease and thrombopathy, well known but not studied by recent tests.The&#xD;
      identification of primary haemostasis deficits with these tools would allow to supply them&#xD;
      and decrease the morbi-mortality related to the transfusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Obsolete study&#xD;
  </why_stopped>
  <start_date type="Actual">February 2016</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate primary hemostasis in patient with ECMO at University Hospital of Rennes</measure>
    <time_frame>Day 5</time_frame>
  </primary_outcome>
  <enrollment type="Actual">5</enrollment>
  <condition>Patients With ECMO</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with ECMO&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient older than 18 years old&#xD;
&#xD;
          -  Patient with ECMO&#xD;
&#xD;
          -  Patient hospitalized in an intensive care unit at the University Hospital of Rennes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known history for constitutional pathology of the primary haemostasis&#xD;
&#xD;
          -  Platelets &lt; 100000 / mm3 or hematocrit &lt; 28 % between H+12 and H+24&#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>CHU de Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>November 17, 2017</last_update_submitted>
  <last_update_submitted_qc>November 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Extracorporeal Membrane Oxygenation (ECMO)</keyword>
  <keyword>Primary hemostasis</keyword>
  <!-- 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/NCT03248596
org study id: 35RC15_3023_ECMO PFA-100
nct id: NCT03248596
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is a better understanding of hemorrhagic events causes in patients with
      ECMO, prevent them and decrease the number of transfusion.
The most frequent complication during ECMO is hemorrhage especially as a curative
      anticoagulant treatment is necessary. The primary hemostasis is also affected with a von
      Willebrand disease and thrombopathy, well known but not studied by recent tests.The
      identification of primary haemostasis deficits with these tools would allow to supply them
      and decrease the morbi-mortality related to the transfusion.
observational model: Case-Only
time perspective: Prospective
measure: Evaluate primary hemostasis in patient with ECMO at University Hospital of Rennes
time frame: Day 5
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor