<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/NCT03832842</url>
  </required_header>
  <id_info>
    <org_study_id>7251</org_study_id>
    <nct_id>NCT03832842</nct_id>
  </id_info>
  <brief_title>Thrombin Generation as a New Test for Anticoagulation Management in Patients With ECMO</brief_title>
  <acronym>ECMOstase</acronym>
  <official_title>Thrombin Generation as a New Test for Anticoagulation Management in Patients With ECMO</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</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>
      ECMO (Extracorporeal Membrane Oxygenation) is a circulatory assistance device aiming at&#xD;
      maintaining or restoring cardiopulmonary circulation. Complications of this device are mainly&#xD;
      hemorrhagic, related to coagulopathy induced by the initial pathology or by the device&#xD;
      itself, or thrombotic and ischemic. One of the major challenges is therefore the management&#xD;
      of a suitable curative anticoagulation, sufficient to limit the activation of hemostasis du&#xD;
      to the ECMO, but reasonable to prevent hemorrhagic complications. To date, there is no&#xD;
      standardized and validated protocol for the management of anticoagulation of patients under&#xD;
      ECMO. The thrombin generation may be a valuable test to manage anticoagulation of patients&#xD;
      with ECMO.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 16, 2019</start_date>
  <completion_date type="Actual">February 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 4, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The endogenous thrombin potential (ETP) will be measured.</measure>
    <time_frame>prior to ECMO placement at Hours 0 (ECMO circulation)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The endogenous thrombin potential (ETP) will be measured.</measure>
    <time_frame>Hours 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The endogenous thrombin potential (ETP) will be measured.</measure>
    <time_frame>daily from Day1 to Day10 and at each dosing of anti-Xa.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Levels of hemostasis parameters:</measure>
    <time_frame>daily from Day1 to Day10</time_frame>
    <description>thrombin generation test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of hemostasis parameters:</measure>
    <time_frame>daily from Day1 to Day10</time_frame>
    <description>platelets</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of hemostasis parameters:</measure>
    <time_frame>daily from Day1 to Day10</time_frame>
    <description>anti-Xa</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of hemostasis parameters:</measure>
    <time_frame>daily from Day1 to Day10</time_frame>
    <description>aPTT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of hemostasis parameters:</measure>
    <time_frame>daily from Day1 to Day10</time_frame>
    <description>prothrombin time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of hemostasis parameters:</measure>
    <time_frame>daily from Day1 to Day10</time_frame>
    <description>fibrinogen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of hemostasis parameters:</measure>
    <time_frame>daily from Day1 to Day10</time_frame>
    <description>factor V</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of hemostasis parameters:</measure>
    <time_frame>daily from Day1 to Day10</time_frame>
    <description>D-dimers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of hemostasis parameters:</measure>
    <time_frame>daily from Day1 to Day10</time_frame>
    <description>antithrombin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of markers of vascular cell activation</measure>
    <time_frame>daily from Day1 to Day10</time_frame>
    <description>microvesicles</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of markers of vascular cell activation</measure>
    <time_frame>daily from Day1 to Day10</time_frame>
    <description>neutrophil extra-cellular traps</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of bleeding events defined by the WHO classification,</measure>
    <time_frame>daily from Day1 to Day10</time_frame>
    <description>type of bleeding (venous or arterial), blood/platelet/plasma transfusion (number, volume), fibrinogen treatment, calcium treatment, therapeutic intervention (surgical/radiological/endoscopic/manual)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of thrombotic and ischemic events: ischemic stroke, limb ischemia, myocardial infarction, ECMO thrombosis</measure>
    <time_frame>daily from Day1 to Day10</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality: number of patients who are dead by day 28</measure>
    <time_frame>day 28</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Implantation of a Veno-arterial or Veno-venous ECMO</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>Blood sample</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood and serum will be sampled.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Implantation of a veno-arterial or veno-venous ECMO during hospitalization in intensive&#xD;
        care unit&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female age ≥ 18 years old&#xD;
&#xD;
          -  Implantation of a veno-arterial or veno-venous ECMO during hospitalization in&#xD;
             intensive care&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient on veno-arterial ECMO after cardiac, cardiopulmonary surgery or after&#xD;
             insertion of a left or biventricular cardiac assist device&#xD;
&#xD;
          -  Contraindication to curative anticoagulation&#xD;
&#xD;
          -  Congenital hemostasis disorder or anatomical abnormality predisposing to hemorrhage&#xD;
             (hemophilia, constitutional thrombocytopathies, Willebrand disease, hereditary&#xD;
             hemorrhagic telangiectasia, etc.)&#xD;
&#xD;
          -  History of heparin-induced thrombocytopenia&#xD;
&#xD;
          -  Moribund patient at the day of inclusion&#xD;
&#xD;
          -  Do Not Resuscitate decision&#xD;
&#xD;
          -  Subject under the protection of justice&#xD;
&#xD;
          -  Subject under guardianship or curatorship&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Breastfeeding&#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>Julie HELMS, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Strasbourg, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service de Réanimation médicale CHU Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 1, 2021</last_update_submitted>
  <last_update_submitted_qc>February 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ECMO</keyword>
  <keyword>thrombin generation test</keyword>
  <keyword>hemostasis</keyword>
  <keyword>bleeding events</keyword>
  <keyword>thrombotic events</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/NCT03832842
org study id: 7251
nct id: NCT03832842
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
ECMO (Extracorporeal Membrane Oxygenation) is a circulatory assistance device aiming at
      maintaining or restoring cardiopulmonary circulation. Complications of this device are mainly
      hemorrhagic, related to coagulopathy induced by the initial pathology or by the device
      itself, or thrombotic and ischemic. One of the major challenges is therefore the management
      of a suitable curative anticoagulation, sufficient to limit the activation of hemostasis du
      to the ECMO, but reasonable to prevent hemorrhagic complications. To date, there is no
      standardized and validated protocol for the management of anticoagulation of patients under
      ECMO. The thrombin generation may be a valuable test to manage anticoagulation of patients
      with ECMO.
observational model: Cohort
time perspective: Prospective
measure: The endogenous thrombin potential (ETP) will be measured.
time frame: prior to ECMO placement at Hours 0 (ECMO circulation)
measure: The endogenous thrombin potential (ETP) will be measured.
time frame: Hours 12
measure: The endogenous thrombin potential (ETP) will be measured.
time frame: daily from Day1 to Day10 and at each dosing of anti-Xa.
measure: Levels of hemostasis parameters:
time frame: daily from Day1 to Day10
description: thrombin generation test
measure: Levels of hemostasis parameters:
time frame: daily from Day1 to Day10
description: platelets
measure: Levels of hemostasis parameters:
time frame: daily from Day1 to Day10
description: anti-Xa
measure: Levels of hemostasis parameters:
time frame: daily from Day1 to Day10
description: aPTT
measure: Levels of hemostasis parameters:
time frame: daily from Day1 to Day10
description: prothrombin time
measure: Levels of hemostasis parameters:
time frame: daily from Day1 to Day10
description: fibrinogen
measure: Levels of hemostasis parameters:
time frame: daily from Day1 to Day10
description: factor V
measure: Levels of hemostasis parameters:
time frame: daily from Day1 to Day10
description: D-dimers
measure: Levels of hemostasis parameters:
time frame: daily from Day1 to Day10
description: antithrombin
measure: Levels of markers of vascular cell activation
time frame: daily from Day1 to Day10
description: microvesicles
measure: Levels of markers of vascular cell activation
time frame: daily from Day1 to Day10
description: neutrophil extra-cellular traps
measure: Incidence of bleeding events defined by the WHO classification,
time frame: daily from Day1 to Day10
description: type of bleeding (venous or arterial), blood/platelet/plasma transfusion (number, volume), fibrinogen treatment, calcium treatment, therapeutic intervention (surgical/radiological/endoscopic/manual)
measure: Incidence of thrombotic and ischemic events: ischemic stroke, limb ischemia, myocardial infarction, ECMO thrombosis
time frame: daily from Day1 to Day10
measure: Mortality: number of patients who are dead by day 28
time frame: day 28
intervention type: Diagnostic Test
intervention name: Blood sample
description: Blood sample
Whole blood and serum will be sampled.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Julie HELMS, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Strasbourg, France
facility: 
country: France
responsible party type: Sponsor