<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/NCT03841084</url>
  </required_header>
  <id_info>
    <org_study_id>ANZIC-RC/DP001</org_study_id>
    <nct_id>NCT03841084</nct_id>
  </id_info>
  <brief_title>Blend to Limit Oxygen in ECMO: A Randomised Controlled Registry Trial</brief_title>
  <acronym>BLENDER</acronym>
  <official_title>Blend to Limit oxygEN in ECMO: a ranDomised controllEd Registry Trial The BLENDER Trial - A Phase II Multicentre Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Australian and New Zealand Intensive Care Research Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Australian and New Zealand Intensive Care Research Centre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine in patients requiring venoarterial (V-A) ECMO, whether the use of a conservative&#xD;
      as compared with liberal oxygen strategy, results in a greater number of ICU-free days at day&#xD;
      60.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Extracorporeal membrane oxygenation (ECMO) can be a lifesaving procedure for the sickest&#xD;
      patients in the Intensive Care Unit (ICU) who are at risk of death from severe cardiac and&#xD;
      respiratory failure. ECMO is a device which pumps blood out of the body and returns it back&#xD;
      after adding oxygen and removing carbon dioxide. While potentially life-saving, ECMO is&#xD;
      associated with high use of critical care resources and increased risk of adverse outcomes in&#xD;
      survivors.&#xD;
&#xD;
      The BLENDER Trial is a multicentre trial in ECMO patients to determine whether a conservative&#xD;
      oxygen strategy during ECMO reduces ICU length of stay and improves patient outcomes compared&#xD;
      to a liberal oxygen strategy. Both strategies are currently standard practice worldwide,&#xD;
      however, there is no consensus to which strategy is better for our patients. This trial aims&#xD;
      to utilise an existing intensive care registry and will recruit 300 patients with life&#xD;
      threatening acute cardiac or respiratory failure. If the BLENDER Trial confirms that one&#xD;
      oxygen management strategy is more effective than the other, its findings may improve the&#xD;
      lives of critically ill Australians and inform clinical practice worldwide.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 18, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This is a phase II, registry-based, multicentre, parallel group randomised controlled trial.&#xD;
(Data retrieved from the EXCEL national clinical registry)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary outcome will be the number of alive and ICU-free days at day 60.</measure>
    <time_frame>at day 60</time_frame>
    <description>ICU free days are defined as the total number of days (or part days) being free of ICU between randomisation and day 60, with the exception that all patients who die by day 60 will be defined as having zero ICU free days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital mortality</measure>
    <time_frame>at day 60</time_frame>
    <description>Mortality rates of patients that day in hospital from randomisation to day 60</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU mortality</measure>
    <time_frame>at day 60</time_frame>
    <description>Mortality rates of patients that day in ICU from randomisation to day 60</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>at day 60</time_frame>
    <description>Number of hours spent in ICU from randomisation up to day 60</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of mechanical ventilation</measure>
    <time_frame>at day 60</time_frame>
    <description>Number of hours requiring mechanical ventilation from randomisation to day 60</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>World Health Organisation's Disability Assessment Schedule 2.0 12L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life at six and twelve months using the EQ5D-5L</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Euro Qol Group Health Survey (EQ-5D-5L) Measuring quality of life which looks at five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological function at six and twelve months</measure>
    <time_frame>6 months &amp; 12 months</time_frame>
    <description>Measured using a trained, blinded assessor via telephone interview</description>
  </secondary_outcome>
  <other_outcome>
    <measure>ECMO circuit life</measure>
    <time_frame>day 60</time_frame>
    <description>number of hours that each circuit was in use</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Cardiac Failure</condition>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>Conservative Oxygen Management Strategy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients allocated to the conservative strategy will have the ECMO blender oxygen fraction (FbO2) will be titrated to achieve a post-oxygenator saturations of 92-96% (the FbO2 cannot be reduced to lower than 0.5). Post-oxygenator arterial blood gases (ABG's) will be taken to ensure safety and to allow for adjustments to be made. The ventilator FiO2 will be titrated to patient oxygen saturations (SpO2) of 92-96%.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Liberal Oxygen Management Strategy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients allocated to the liberal strategy will have the FbO2 set at 1.0 at all times. The ventilator FiO2 will be titrated to achieve a patient oxygen saturations (SpO2) of 97-100% (but not lower than 0.5).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxygen</intervention_name>
    <description>Conservative oxygen management strategy- reduces oxygen on the inoblender in the ECMO circuit.&#xD;
Liberal oxygen management strategy - does not reduce the oxygen on the inoblender via the ECMO circuit</description>
    <arm_group_label>Conservative Oxygen Management Strategy</arm_group_label>
    <arm_group_label>Liberal Oxygen Management Strategy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Patients ≥18 years who are commenced on V-A ECMO for severe cardiac, or following&#xD;
        refractory cardiac arrest.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Greater than 6 hours have elapsed from the time of initiation of ECMO to randomisation&#xD;
&#xD;
          -  Patients who are suspected or confirmed to be pregnant&#xD;
&#xD;
          -  Where an indication exists for a specific oxygen target as part of clinical care (e.g.&#xD;
             carbon monoxide poisoning)&#xD;
&#xD;
          -  Patients who are already enrolled in another oxygen titration study (unless agreed by&#xD;
             study committees)&#xD;
&#xD;
          -  Patients not willing to receive blood products (e.g. Jehovah's Witness)&#xD;
&#xD;
          -  Where the treating physician deems the study is not in the patient's best interest&#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>David Pilcher</last_name>
    <role>Principal Investigator</role>
    <affiliation>Monash University, Australian &amp; New Zealand Intensive Care research Centre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kelly Ottosen</last_name>
    <phone>(03) 99030034</phone>
    <email>kelly.ottosen@monash.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Alfred Health</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emma Martin</last_name>
      <phone>(03) 90768343</phone>
      <email>E.Martin2@alfred.org.au</email>
    </contact>
    <investigator>
      <last_name>Aidan Burrell</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>March 20, 2023</last_update_submitted>
  <last_update_submitted_qc>March 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ECMO</keyword>
  <keyword>V-A ECMO</keyword>
  <keyword>Oxygen</keyword>
  <keyword>Hyperoxia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03841084
org study id: ANZIC-RC/DP001
nct id: NCT03841084
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
To determine in patients requiring venoarterial (V-A) ECMO, whether the use of a conservative
      as compared with liberal oxygen strategy, results in a greater number of ICU-free days at day
      60.
Extracorporeal membrane oxygenation (ECMO) can be a lifesaving procedure for the sickest
      patients in the Intensive Care Unit (ICU) who are at risk of death from severe cardiac and
      respiratory failure. ECMO is a device which pumps blood out of the body and returns it back
      after adding oxygen and removing carbon dioxide. While potentially life-saving, ECMO is
      associated with high use of critical care resources and increased risk of adverse outcomes in
      survivors.

      The BLENDER Trial is a multicentre trial in ECMO patients to determine whether a conservative
      oxygen strategy during ECMO reduces ICU length of stay and improves patient outcomes compared
      to a liberal oxygen strategy. Both strategies are currently standard practice worldwide,
      however, there is no consensus to which strategy is better for our patients. This trial aims
      to utilise an existing intensive care registry and will recruit 300 patients with life
      threatening acute cardiac or respiratory failure. If the BLENDER Trial confirms that one
      oxygen management strategy is more effective than the other, its findings may improve the
      lives of critically ill Australians and inform clinical practice worldwide.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a phase II, registry-based, multicentre, parallel group randomised controlled trial.
(Data retrieved from the EXCEL national clinical registry)
primary purpose: Treatment
masking: None (Open Label)
measure: The primary outcome will be the number of alive and ICU-free days at day 60.
time frame: at day 60
description: ICU free days are defined as the total number of days (or part days) being free of ICU between randomisation and day 60, with the exception that all patients who die by day 60 will be defined as having zero ICU free days.
measure: Hospital mortality
time frame: at day 60
description: Mortality rates of patients that day in hospital from randomisation to day 60
measure: ICU mortality
time frame: at day 60
description: Mortality rates of patients that day in ICU from randomisation to day 60
measure: ICU length of stay
time frame: at day 60
description: Number of hours spent in ICU from randomisation up to day 60
measure: Duration of mechanical ventilation
time frame: at day 60
description: Number of hours requiring mechanical ventilation from randomisation to day 60
measure: Disability
time frame: 6 and 12 months
description: World Health Organisation's Disability Assessment Schedule 2.0 12L
measure: Health-related quality of life at six and twelve months using the EQ5D-5L
time frame: 6 and 12 months
description: Euro Qol Group Health Survey (EQ-5D-5L) Measuring quality of life which looks at five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
measure: Psychological function at six and twelve months
time frame: 6 months & 12 months
description: Measured using a trained, blinded assessor via telephone interview
measure: ECMO circuit life
time frame: day 60
description: number of hours that each circuit was in use
arm group label: Conservative Oxygen Management Strategy
arm group type: Active Comparator
description: Patients allocated to the conservative strategy will have the ECMO blender oxygen fraction (FbO2) will be titrated to achieve a post-oxygenator saturations of 92-96% (the FbO2 cannot be reduced to lower than 0.5). Post-oxygenator arterial blood gases (ABG's) will be taken to ensure safety and to allow for adjustments to be made. The ventilator FiO2 will be titrated to patient oxygen saturations (SpO2) of 92-96%.
arm group label: Liberal Oxygen Management Strategy
arm group type: Active Comparator
description: Patients allocated to the liberal strategy will have the FbO2 set at 1.0 at all times. The ventilator FiO2 will be titrated to achieve a patient oxygen saturations (SpO2) of 97-100% (but not lower than 0.5).
intervention type: Drug
intervention name: Oxygen
description: Conservative oxygen management strategy- reduces oxygen on the inoblender in the ECMO circuit.
Liberal oxygen management strategy - does not reduce the oxygen on the inoblender via the ECMO circuit
arm group label: Conservative Oxygen Management Strategy
arm group label: Liberal Oxygen Management Strategy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Pilcher
role: Principal Investigator
affiliation: Monash University, Australian & New Zealand Intensive Care research Centre
last name: Kelly Ottosen
phone: (03) 99030034
email: kelly.ottosen@monash.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: Australia
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Critical Illness
sharing ipd: Undecided