xml: <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/NCT06010446</url>
    </required_header>
    <id_info>
      <org_study_id>15082023</org_study_id>
      <nct_id>NCT06010446</nct_id>
    </id_info>
    <brief_title>Intravenous Continuous LMWH Seems to be Safe Alternative to UFH in VV ECMO Patients</brief_title>
    <official_title>Intravenous Continuous LMWH (Enoxaparin) Seems to be Safe Alternative to UFH in Patients With VV ECMO</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Motol</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Motol</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>
        Unfractionated heparin (UFH) is worldwide anticoagulation used and recommended&#xD;
        anticoagulation in patients with ECMO support. However, it is accompanied with incidence of&#xD;
        bleeding or thrombotic compliaction at about 40-60% and high mortality. Because ECMO produce&#xD;
        primary haemosthasis pathology, there is a theory that prophylaxis of thrombosis with low&#xD;
        molecular weight heparin (LMWH) e.g. Enoxaparin might be sufficient to prevent ECMO throbosis&#xD;
        and thrombosis development in patients.&#xD;
  &#xD;
        We decided to performed retrospective observation study and analysis of data, from may 2019&#xD;
        until august 2023, in all patients who were put on VV ECMO and to analysis incidence of&#xD;
        bleeding, thrombotic and neurologic complications.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Unfractionated heparin (UFH) is worldwide anticoagulation used and recommended&#xD;
        anticoagulation in patients with ECMO support. However, it is accompanied with incidence of&#xD;
        bleeding or thrombotic compliaction at about 40-60% and high mortality. Because ECMO produce&#xD;
        primary haemosthasis pathology, there is a theory that prophylaxis of thrombosis with low&#xD;
        molecular weight heparin (LMWH) e.g. Enoxaparin might be sufficient to prevent ECMO throbosis&#xD;
        and thrombosis development in patients. This phenomenon of primary haemosthasis pathology may&#xD;
        protect ECMO from thrombotic complication as primary haemosthasis plays major role in&#xD;
        haemosthasis taking places in high shear stress condiditon such as ECMO. Because LMWH is&#xD;
        connected with lower incidence of bleeding complication and HIT (heparin induced&#xD;
        thrombocytopenia) in general, in case that patients on VV ECMO developed primary haemosthasis&#xD;
        pathology detected by PFA 200, we started to use LMWH instead of UFH in VV ECMO patients.&#xD;
  &#xD;
        We decided to performed retrospective observation study and analysis of data, from may 2019&#xD;
        until august 2023, in all patients who were put on VV ECMO and to analysis incidence of&#xD;
        bleeding, thrombotic and neurologic complications. We want to compare this incidence of&#xD;
        compliactions with data known from patients with other studies using UFH.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 15, 2019</start_date>
    <completion_date type="Actual">August 15, 2023</completion_date>
    <primary_completion_date type="Actual">August 15, 2023</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>Incidence of major bleeding complications</measure>
      <time_frame>Daty from may 2019 till august 2023</time_frame>
      <description>Defined by ECMO registry</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of major thrombotic complications</measure>
      <time_frame>Daty from may 2019 till august 2023</time_frame>
      <description>Defined by ECMO registry</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of major neurologic complications</measure>
      <time_frame>Daty from may 2019 till august 2023</time_frame>
      <description>Defined by ECMO registry</description>
    </primary_outcome>
    <enrollment type="Actual">43</enrollment>
    <condition>Refractory Respiratory Failure</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No intervention, just retrospective analysis of data.</intervention_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          patients with respiratory failure put VV ECMO&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  VV ECMO - use of 2 separate cannulas (jugular and femoral)&#xD;
  &#xD;
            -  anticoagulation with only intravenous continuous LMWH (Enoxaparin)&#xD;
  &#xD;
            -  only a period of the first ECMO set running&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  pregnancy&#xD;
  &#xD;
            -  Avalon cannula (one double lumen cannula)&#xD;
  &#xD;
            -  patients after thoraco-abdominal surgery&#xD;
  &#xD;
            -  patients after lung transplantation in early postoperative period&#xD;
  &#xD;
            -  patients after trauma without any type of heparin ,,heparin free&quot; ECMO&#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>Miroslav Durila, prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of anesthesiology and intensive care medicine, Motol Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Unoversity Hospital Motol, Department of Anaesthesiology and Intensive Care</name>
        <address>
          <city>Prague</city>
          <zip>150 06</zip>
          <country>Czechia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Czechia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Hospital, Motol</investigator_affiliation>
      <investigator_full_name>Durila Miroslav MUDr. Ph.D.</investigator_full_name>
      <investigator_title>prof.MD. Miroslav Durila, Ph.D., MHA</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Insufficiency</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06010446
  org study id: 15082023
  nct id: NCT06010446
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Unfractionated heparin (UFH) is worldwide anticoagulation used and recommended
        anticoagulation in patients with ECMO support. However, it is accompanied with incidence of
        bleeding or thrombotic compliaction at about 40-60% and high mortality. Because ECMO produce
        primary haemosthasis pathology, there is a theory that prophylaxis of thrombosis with low
        molecular weight heparin (LMWH) e.g. Enoxaparin might be sufficient to prevent ECMO throbosis
        and thrombosis development in patients.
  
        We decided to performed retrospective observation study and analysis of data, from may 2019
        until august 2023, in all patients who were put on VV ECMO and to analysis incidence of
        bleeding, thrombotic and neurologic complications.
  Unfractionated heparin (UFH) is worldwide anticoagulation used and recommended
        anticoagulation in patients with ECMO support. However, it is accompanied with incidence of
        bleeding or thrombotic compliaction at about 40-60% and high mortality. Because ECMO produce
        primary haemosthasis pathology, there is a theory that prophylaxis of thrombosis with low
        molecular weight heparin (LMWH) e.g. Enoxaparin might be sufficient to prevent ECMO throbosis
        and thrombosis development in patients. This phenomenon of primary haemosthasis pathology may
        protect ECMO from thrombotic complication as primary haemosthasis plays major role in
        haemosthasis taking places in high shear stress condiditon such as ECMO. Because LMWH is
        connected with lower incidence of bleeding complication and HIT (heparin induced
        thrombocytopenia) in general, in case that patients on VV ECMO developed primary haemosthasis
        pathology detected by PFA 200, we started to use LMWH instead of UFH in VV ECMO patients.
  
        We decided to performed retrospective observation study and analysis of data, from may 2019
        until august 2023, in all patients who were put on VV ECMO and to analysis incidence of
        bleeding, thrombotic and neurologic complications. We want to compare this incidence of
        compliactions with data known from patients with other studies using UFH.
  observational model: Cohort
  time perspective: Retrospective
  measure: Incidence of major bleeding complications
  time frame: Daty from may 2019 till august 2023
  description: Defined by ECMO registry
  measure: Incidence of major thrombotic complications
  time frame: Daty from may 2019 till august 2023
  description: Defined by ECMO registry
  measure: Incidence of major neurologic complications
  time frame: Daty from may 2019 till august 2023
  description: Defined by ECMO registry
  intervention type: Other
  intervention name: No intervention, just retrospective analysis of data.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Miroslav Durila, prof.
  role: Principal Investigator
  affiliation: Department of anesthesiology and intensive care medicine, Motol Hospital
  facility: 
  country: Czechia
  responsible party type: Principal Investigator
  investigator affiliation: University Hospital, Motol
  investigator full name: Durila Miroslav MUDr. Ph.D.
  investigator title: prof.MD. Miroslav Durila, Ph.D., MHA
  mesh term: Respiratory Insufficiency
  sharing ipd: No