<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/NCT04480151</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2020/37</org_study_id>
    <nct_id>NCT04480151</nct_id>
  </id_info>
  <brief_title>ECLS Versus IMPELLA™ as Bridge to LVAD (ECI-BLAD)</brief_title>
  <acronym>ECI-BLAD</acronym>
  <official_title>ExtraCorporeal Life Support (ECLS) Versus IMPELLA™ Pump as Bridge to Left Ventricular Assist Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this retrospective observational multicenter study the authors tested the hypothesis that&#xD;
      the use of IMPELLA™ pump as bridge to bridge, by giving the opportunity of active&#xD;
      rehabilitation, should improve patient's outcomes after the implantation of Left Ventricular&#xD;
      Assist Device (LVAD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      End stage heart failure patients admitted in Intensive Care Unit (ICU) for refractory&#xD;
      cardiogenic shock requiring short-term mechanical circulatory support as a bridge to a&#xD;
      long-term LVAD might benefit from early mobilization and rehabilitation with IMPELLA™&#xD;
      inserted via the axillary artery. The aim of this study is to compare the early&#xD;
      rehabilitation and outcomes after LVAD implantation between patients previously treated by&#xD;
      IMPELLA™ or ExtraCorporeal Life Support (ECLS)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2021</start_date>
  <completion_date type="Actual">April 21, 2021</completion_date>
  <primary_completion_date type="Actual">April 21, 2021</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>Proportion of patients alive in the surgery ward, not requiring intravenous access and walking (John Hopkins highest level of mobility (JH-HLM) scale = 8 at 30 days after the LVAD implantation</measure>
    <time_frame>Day 30 after Left Ventricular Assist Device (LVAD) implantation</time_frame>
    <description>Proportion of patients alive in the surgery ward, not requiring intravenous access and walking (John Hopkins highest level of mobility (JH-HLM) scale = 8) at 30 days after the LVAD implantation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complication and rehabilitation under Short-term Mechanical Circulatory support</measure>
    <time_frame>The day of Left Ventricular Assist Device (LVAD) implantation</time_frame>
    <description>Duration of support, bleeding, hemolysis, surgical re-exploration, thombus, renal replacement therapy, blood products transfusion, stroke, tracheal extubation, mobilization (chair, walking and ergometry)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Organ dysfunction before LVAD implantation</measure>
    <time_frame>The day before LVAD implantation</time_frame>
    <description>Need for mechanical ventilation, Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>complication Under LVAD</measure>
    <time_frame>The day of Intensive Care Unit (ICU) discharge</time_frame>
    <description>bleeding, right ventricular dysfunction, vasoplegia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SOFA score</measure>
    <time_frame>The day of Short Term Mechanical Circulatory Support (STMCS) implantation</time_frame>
    <description>Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SOFA score</measure>
    <time_frame>The day of LVAD implantation</time_frame>
    <description>Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SOFA score</measure>
    <time_frame>Day 1 post LVAD implantation</time_frame>
    <description>Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SOFA score</measure>
    <time_frame>Day 3 post LVAD implantation</time_frame>
    <description>Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SOFA score</measure>
    <time_frame>Day 5 post LVAD implantation</time_frame>
    <description>Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SOFA score</measure>
    <time_frame>Day 7 post LVAD implantation</time_frame>
    <description>Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital status</measure>
    <time_frame>1 month after LVAD implantation</time_frame>
    <description>mortality after LVAD implantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital status</measure>
    <time_frame>3 months after LVAD implantation</time_frame>
    <description>mortality after LVAD implantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital status</measure>
    <time_frame>6 months after LVAD implantation</time_frame>
    <description>mortality after LVAD implantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of stay</measure>
    <time_frame>up to Intensive Care Unit (ICU) discharge (not more than 6 months after LVAD implantation)</time_frame>
    <description>Intensive Care Unit length of stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of stay</measure>
    <time_frame>up to hospital discharge (not more than 6 months after LVAD implantation)</time_frame>
    <description>hospital length of stay</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">92</enrollment>
  <condition>Cardiogenic Shock</condition>
  <condition>End-stage Heart Failure</condition>
  <arm_group>
    <arm_group_label>IMPELLA™ alone as bridge to LVAD</arm_group_label>
    <description>patients assisted by IMPELLA™ pump alone during the days preceding the implantation of long term LVAD (at least 48 hours for patients for whom an ECLS was previously used)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ECLS alone or with IMPELLA™ as bridge to LVAD</arm_group_label>
    <description>patients assisted by ECLS (ExtraCorporeal life support) alone or simultaneously with IMPELLA™ until the implantation of LVAD</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standard of care</intervention_name>
    <description>retrospective study: standard of care</description>
    <arm_group_label>ECLS alone or with IMPELLA™ as bridge to LVAD</arm_group_label>
    <arm_group_label>IMPELLA™ alone as bridge to LVAD</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        consecutive patients implanted by IMPELLA™ pump or ECLS as a bridge to long duration LVAD&#xD;
        between January 2012 and December 2018 in five university hospital centers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients supported with IMPELLA™ or ECLS for refractory cardiogenic shock as a bridge&#xD;
             to long duration LVAD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusing to give access to their medical chart&#xD;
&#xD;
          -  Guardianship and curactorship&#xD;
&#xD;
          -  Deprived of liberty&#xD;
&#xD;
          -  short term mechanical circulatory system weaned before LVAD implantation&#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>Alexandre OUATTARA, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Bordeaux</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Dijon-Bourgoigne</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Bordeaux</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 6, 2021</last_update_submitted>
  <last_update_submitted_qc>July 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cardiogenic shock</keyword>
  <keyword>end stage heart failure</keyword>
  <keyword>bridge to bridge</keyword>
  <keyword>bridge to decision</keyword>
  <keyword>left ventricular assist device</keyword>
  <keyword>IMPELLA™</keyword>
  <keyword>ECLS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Shock, Cardiogenic</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/NCT04480151
org study id: CHUBX 2020/37
nct id: NCT04480151
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In this retrospective observational multicenter study the authors tested the hypothesis that
      the use of IMPELLA™ pump as bridge to bridge, by giving the opportunity of active
      rehabilitation, should improve patient's outcomes after the implantation of Left Ventricular
      Assist Device (LVAD).
End stage heart failure patients admitted in Intensive Care Unit (ICU) for refractory
      cardiogenic shock requiring short-term mechanical circulatory support as a bridge to a
      long-term LVAD might benefit from early mobilization and rehabilitation with IMPELLA™
      inserted via the axillary artery. The aim of this study is to compare the early
      rehabilitation and outcomes after LVAD implantation between patients previously treated by
      IMPELLA™ or ExtraCorporeal Life Support (ECLS)
observational model: Cohort
time perspective: Retrospective
measure: Proportion of patients alive in the surgery ward, not requiring intravenous access and walking (John Hopkins highest level of mobility (JH-HLM) scale = 8 at 30 days after the LVAD implantation
time frame: Day 30 after Left Ventricular Assist Device (LVAD) implantation
description: Proportion of patients alive in the surgery ward, not requiring intravenous access and walking (John Hopkins highest level of mobility (JH-HLM) scale = 8) at 30 days after the LVAD implantation
measure: Complication and rehabilitation under Short-term Mechanical Circulatory support
time frame: The day of Left Ventricular Assist Device (LVAD) implantation
description: Duration of support, bleeding, hemolysis, surgical re-exploration, thombus, renal replacement therapy, blood products transfusion, stroke, tracheal extubation, mobilization (chair, walking and ergometry)
measure: Organ dysfunction before LVAD implantation
time frame: The day before LVAD implantation
description: Need for mechanical ventilation, Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]
measure: complication Under LVAD
time frame: The day of Intensive Care Unit (ICU) discharge
description: bleeding, right ventricular dysfunction, vasoplegia
measure: SOFA score
time frame: The day of Short Term Mechanical Circulatory Support (STMCS) implantation
description: Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]
measure: SOFA score
time frame: The day of LVAD implantation
description: Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]
measure: SOFA score
time frame: Day 1 post LVAD implantation
description: Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]
measure: SOFA score
time frame: Day 3 post LVAD implantation
description: Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]
measure: SOFA score
time frame: Day 5 post LVAD implantation
description: Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]
measure: SOFA score
time frame: Day 7 post LVAD implantation
description: Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]
measure: Vital status
time frame: 1 month after LVAD implantation
description: mortality after LVAD implantation
measure: Vital status
time frame: 3 months after LVAD implantation
description: mortality after LVAD implantation
measure: Vital status
time frame: 6 months after LVAD implantation
description: mortality after LVAD implantation
measure: length of stay
time frame: up to Intensive Care Unit (ICU) discharge (not more than 6 months after LVAD implantation)
description: Intensive Care Unit length of stay
measure: length of stay
time frame: up to hospital discharge (not more than 6 months after LVAD implantation)
description: hospital length of stay
arm group label: IMPELLA™ alone as bridge to LVAD
description: patients assisted by IMPELLA™ pump alone during the days preceding the implantation of long term LVAD (at least 48 hours for patients for whom an ECLS was previously used)
arm group label: ECLS alone or with IMPELLA™ as bridge to LVAD
description: patients assisted by ECLS (ExtraCorporeal life support) alone or simultaneously with IMPELLA™ until the implantation of LVAD
intervention type: Other
intervention name: standard of care
description: retrospective study: standard of care
arm group label: ECLS alone or with IMPELLA™ as bridge to LVAD
arm group label: IMPELLA™ alone as bridge to LVAD
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexandre OUATTARA, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Bordeaux
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Shock, Cardiogenic
sharing ipd: No