<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/NCT03793257</url>
  </required_header>
  <id_info>
    <org_study_id>ANZIC-RC/CH003</org_study_id>
    <nct_id>NCT03793257</nct_id>
  </id_info>
  <brief_title>The EXCEL Registry of Patients Requiring ECMO</brief_title>
  <official_title>The EXCEL Registry: A Comprehensive Binational Registry on the Treatment and Outcomes of Patients Requiring ECMO</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Australian and New Zealand Intensive Care Research Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Health and Medical Research Council, Australia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Extracorporeal Life Support Organization</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Heart Foundation, Australia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Alfred</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Barwon Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fiona Stanley Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Prince Charles Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Royal Prince Alfred Hospital, Sydney, Australia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St Vincent's Hospital, Sydney</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Australian and New Zealand Intensive Care Research Centre</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 is associated with significant costs, risks and requires specialist training and&#xD;
      expertise. EXCEL is a novel, high-quality, detailed prospective registry of patients&#xD;
      requiring ECMO in Australia and New Zealand. The registry provides information on patient&#xD;
      selection, complications, costs and patient reported outcome measures. EXCEL uses the&#xD;
      Theoretical Domains Framework to identify evidence-practice gaps and explore barriers and&#xD;
      enablers to tailor implementation of evidence&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of EXCEL is to generate a bi-national multidisciplinary network of integrated care&#xD;
      for patients suffering acute cardiac or respiratory failure or cardiac arrest requiring&#xD;
      extracorporeal membrane oxygenation (ECMO) to monitor long term outcomes and identify best&#xD;
      practice.&#xD;
&#xD;
      Each year around 130,000 Australians and New Zealanders are admitted to an intensive care&#xD;
      unit (ICU). The sickest patients in the ICU who have severe failure of the heart or lungs may&#xD;
      require an external machine to oxygenate their blood in addition to a mechanical ventilator.&#xD;
      This intervention, called extracorporeal membrane oxygenation (ECMO), involves circulating&#xD;
      all of the patient's blood through large cannulae to external machinery every minute. It has&#xD;
      the capability of completely replacing a non-functioning heart or lungs for days to weeks on&#xD;
      end. These critically ill patients who require ECMO are the sickest in the hospital with only&#xD;
      42% hospital survival. The use of ECMO has doubled in Australia and New Zealand and globally&#xD;
      over five years, and in the USA has increased by 433%.&#xD;
&#xD;
      The use of ECMO is associated with significant costs and risks, and it requires specialist&#xD;
      training and expertise. In order to prepare for the organisation of these complex&#xD;
      interventions in the ICU across regions, the investigators need to have accurate data on&#xD;
      patients undergoing ECMO. The investigators monitor and review current practice in ECMO&#xD;
      services by providing robust binational registry data to service providers and clinicians&#xD;
      with a closed-loop feedback system. EXCEL explores barriers and enablers to evidence-based&#xD;
      care in ECMO services and providing a platform to embed clinical trials. The investigators&#xD;
      will translate findings with greater capacity, reach, and impact to drive measureable change&#xD;
      in practice and improve patient-centred outcomes.&#xD;
&#xD;
      The EXCEL Partnership represents a novel, coordinated effort to create a high-quality,&#xD;
      detailed, prospective registry of patients requiring ECMO at ECMO centres. A tailored,&#xD;
      detailed ECMO registry (EXCEL) can be used to address specific safety concerns, clinical&#xD;
      questions and process of care issues. As a result, EXCEL can be designed and implemented to&#xD;
      answer new investigator-initiated, hypothesis-driven clinical questions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2027</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2026</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Disability-free survival at 6 months, defined as alive and free of disability, measured with the World Health Organisation's Disability Assessment Schedule (WHODAS 2.0) score of &lt;25%.</measure>
    <time_frame>At 6 months from study enrolment</time_frame>
    <description>WHODAS 2.0 measured using a trained, blinded assessor via telephone interview. The WHODAS scores are calculated using the sum of the six domain scores. These domain scores are then converted to a metric score ranging from 0 to 100 (where 0= no disability; 100= full disability)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events including major bleeding up to 28 days after ECMO, infection, thrombosis (in the ECMO cannulae or in the patient) and limb ischaemia</measure>
    <time_frame>Up to 28 days after ECMO initiation</time_frame>
    <description>All adverse events are recorded determined by treating clinician</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare utilization - caseload per centre</measure>
    <time_frame>Up to 12 months from study enrolment</time_frame>
    <description>ECMO patient numbers (caseload per centre)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare utilization - ECMO initiation timing</measure>
    <time_frame>Up to 12 months from study enrolment</time_frame>
    <description>Timing of ECMO initiation by staff including an ECMO retrieval team</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare utilization - number of staff members required to manage ECMO</measure>
    <time_frame>Up to 12 months from study enrolment</time_frame>
    <description>Staff numbers required for the provision of ECMO in ICU and the training required for these staff members to perform their role.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare utilization - hospital length of stay</measure>
    <time_frame>Up to 12 months from study enrolment</time_frame>
    <description>Hospital and in-patient rehabilitation length of stay including hospital readmissions and time spent in ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare costs</measure>
    <time_frame>Measured from ECMO commencement to hospital discharge until 6 months following hopsital admission.</time_frame>
    <description>Number of resources including staff and, equipment and blood products utilised whilst the patient was receiving hospital care until 6 months following hospital admission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life at baseline, 6 and 12 months using the EQ5D-5L</measure>
    <time_frame>At 6 and 12 months from study enrolment. Retrospective baseline measured at 6 months.</time_frame>
    <description>Measured using the EQ5D-5L, delivered by a trained, blinded assessor via telephone interview. The EQ5D includes an analogue scale that asks the patient to rate their health on a scale of 0 to 100. (Where 0= worst health imaginable; 100= best health imaginable)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with disability at 6 and 12 months</measure>
    <time_frame>At 6 and 12 months from study enrolment</time_frame>
    <description>Measured using the WHODAS 2.0, delivered by a trained, blinded assessor via telephone interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological function at 12 months</measure>
    <time_frame>At 12 months from study enrolment</time_frame>
    <description>Measured using the EQ5D-5L, delivered by a trained, blinded assessor via telephone interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to work at 6 months</measure>
    <time_frame>At 6 months from study enrolment</time_frame>
    <description>Return to work measured bu the WHODAS 2.0, delivered by a trained, blinded assessor via telephone interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability at baseline, 6 and 12 months</measure>
    <time_frame>Measured at 6 and 12 months. Retrospective baseline disability measured at 6 months.</time_frame>
    <description>Patient reported disability using a disability scale, delivered by a trained, blinded assessor via telephone interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activities of daily living at 6 and 12 months</measure>
    <time_frame>Measured at 6 and 12 months</time_frame>
    <description>Activities of daily living measured at 6 and 12 month using the ADL and IADL, delivered by a trained, blinded assessor via telephone interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function at 12 months</measure>
    <time_frame>Measured at 12 months</time_frame>
    <description>Cognitive function measured at 12 months using the MOCA Blind, delivered by a trained, blinded assessor via telephone interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number patients who survive to 12 months following ECMO initiation</measure>
    <time_frame>At 12 months from study enrolment</time_frame>
    <description>Measured by Research Coordinators at each of the participating sites</description>
  </secondary_outcome>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Critically Ill</condition>
  <condition>Acute Respiratory Failure</condition>
  <condition>Acute Heart Failure</condition>
  <condition>Cardiac Arrest</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to hospitals with a primary diagnosis of acute heart failure, respiratory&#xD;
        failure or cardiac arrest and received ECMO at participating ECMO centres.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted to adult hospitals and receive ECMO in Australia and New Zealand&#xD;
&#xD;
        Nil Exclusion Criteria&#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>Carol L Hodgson, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Australian and New Zealand Intensive Care Research Centre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Carol L Hodgson, PhD</last_name>
    <phone>+613 9903 0598</phone>
    <email>carol.hodgson@monash.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ben Fulcher</last_name>
    <phone>+613 9903 0930</phone>
    <email>bentley.fulcher@monash.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Canberra Hospital</name>
      <address>
        <city>Canberra</city>
        <state>Australian Capital Territory</state>
        <zip>2605</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>hemanth.veerendra@act.gov.au</email>
    </contact>
    <investigator>
      <last_name>Hemanth Veerendra, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Prince Alfred Hospital</name>
      <address>
        <city>Camperdown</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>richard.totaro@health.nsw.gov.au</email>
    </contact>
    <investigator>
      <last_name>Richard Totaro, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St Vincent's Hospital Sydney</name>
      <address>
        <city>Darlinghurst</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>pnair@svha.org.au</email>
    </contact>
    <investigator>
      <last_name>Priya Nair, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Liverpool Hospital</name>
      <address>
        <city>Liverpool</city>
        <state>New South Wales</state>
        <zip>2170</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>peter.mccanny@health.nsw.gov.au</email>
    </contact>
    <investigator>
      <last_name>Peter McCanny, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>John Hunter Hospital</name>
      <address>
        <city>Newcastle</city>
        <state>New South Wales</state>
        <zip>2305</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>jorge.brieva@hnehealth.nsw.gov.au</email>
    </contact>
    <investigator>
      <last_name>Jorge Brieva, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal North Shore Hospital</name>
      <address>
        <city>St Leonards</city>
        <state>New South Wales</state>
        <zip>2065</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>pjanin@skmx.net</email>
    </contact>
    <investigator>
      <last_name>Pierre Janin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2031</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>gavin.salt@health.nsw.gov.au</email>
    </contact>
    <investigator>
      <last_name>Gavin Salt, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St George Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2217</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>c.slawomirski@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Christof Slawomirski, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Westmead Hospital</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>benjamin.davidson@health.nsw.gov.au</email>
    </contact>
    <investigator>
      <last_name>Benjamin Davidson, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Brisbane and Women's Hospital</name>
      <address>
        <city>Brisbane</city>
        <state>Queensland</state>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>jason.pincus@health.qld.gov.au</email>
    </contact>
    <investigator>
      <last_name>Jason Pincus, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Princess Alexandra Hospital</name>
      <address>
        <city>Brisbane</city>
        <state>Queensland</state>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>james.walsham@health.qld.gov.au</email>
    </contact>
    <investigator>
      <last_name>James Walsham, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Prince Charles Hospital</name>
      <address>
        <city>Chermside</city>
        <state>Queensland</state>
        <zip>4032</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>fraserjohn001@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Jayshree Lavana, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>John Fraser, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gold Coast University Hospital</name>
      <address>
        <city>Southport</city>
        <state>Queensland</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>james.winearls@health.qld.gov.au</email>
    </contact>
    <investigator>
      <last_name>James Winearls, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sunshine Coast University Hospital</name>
      <address>
        <city>Sunshine Coast</city>
        <state>Queensland</state>
        <zip>4575</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Townsville Hospital</name>
      <address>
        <city>Townsville</city>
        <state>Queensland</state>
        <zip>4814</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>april.win@health.qld.gov.au</email>
    </contact>
    <investigator>
      <last_name>April Win, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hosptial</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>benjamin.reddi@sa.gov.au</email>
    </contact>
    <investigator>
      <last_name>Benjamin Reddi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Flinders Medical Centre</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5042</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>biharishailesh@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Shailesh Bihari, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Launceston General Hospital</name>
      <address>
        <city>Launceston</city>
        <state>Tasmania</state>
        <zip>7250</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>matt.brain@ths.tas.gov.au</email>
    </contact>
    <investigator>
      <last_name>Matthew Brain, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Box Hill Hospital</name>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>john.dyett@easternhealth.org.au</email>
    </contact>
    <investigator>
      <last_name>John Dyett, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Monash Medical Centre</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>brendan.murfin@monashhealth.org</email>
    </contact>
    <investigator>
      <last_name>Brendan Murfin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital Geelong</name>
      <address>
        <city>Geelong</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>joemccaffrey77@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Joe McCaffrey, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Austin Health</name>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>rinaldo.bellomo@austin.org.au</email>
    </contact>
    <investigator>
      <last_name>Rinaldo Bellomo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Alfred Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>v.pellegrino@alfred.org.au</email>
    </contact>
    <investigator>
      <last_name>Vincent Pellegrino, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St Vincent's Hospital Melbourne</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>yvette.obrien@svha.org.au</email>
    </contact>
    <investigator>
      <last_name>Yvette O'Brien, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Melbourne Hospital</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>james.anstey@mh.org.au</email>
    </contact>
    <investigator>
      <last_name>James Anstey, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Epworth Hospital</name>
      <address>
        <city>Richmond</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>kyle.brooks@epworth.org.au</email>
    </contact>
    <investigator>
      <last_name>Kyle Brooks, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sir Charles Gairdner Hospital</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>stephen.richards@health.wa.gov.au</email>
    </contact>
    <investigator>
      <last_name>Steve Richards, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fiona Stanley Hospital</name>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6150</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>chris.allen@health.wa.gov.au</email>
    </contact>
    <investigator>
      <last_name>Chris Allen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Auckland City hospital</name>
      <address>
        <city>Auckland</city>
        <zip>1023</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>shaymc@adhb.govt.nz</email>
    </contact>
    <investigator>
      <last_name>Shay McGuinness, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>New Zealand</country>
  </location_countries>
  <link>
    <url>https://www.monash.edu/medicine/sphpm/excel/home</url>
    <description>EXCEL Registry Website</description>
  </link>
  <results_reference>
    <citation>Hodgson CL, Higgins AM, Bailey MJ, Anderson S, Bernard S, Fulcher BJ, Koe D, Linke NJ, Board JV, Brodie D, Buhr H, Burrell AJC, Cooper DJ, Fan E, Fraser JF, Gattas DJ, Hopper IK, Huckson S, Litton E, McGuinness SP, Nair P, Orford N, Parke RL, Pellegrino VA, Pilcher DV, Sheldrake J, Reddi BAJ, Stub D, Trapani TV, Udy AA, Serpa Neto A; EXCEL Study Investigators on behalf of the International ECMO Network and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Incidence of death or disability at 6 months after extracorporeal membrane oxygenation in Australia: a prospective, multicentre, registry-embedded cohort study. Lancet Respir Med. 2022 Nov;10(11):1038-1048. doi: 10.1016/S2213-2600(22)00248-X. Epub 2022 Sep 26.</citation>
    <PMID>36174613</PMID>
  </results_reference>
  <results_reference>
    <citation>Fulcher BJ, Nicholson AJ, Linke NJ, Berkovic D, Hodgson CL; EXCEL Study Investigators and the International ECMO Network. The perceived barriers and facilitators to implementation of ECMO services in acute hospitals. Intensive Care Med. 2020 Nov;46(11):2115-2117. doi: 10.1007/s00134-020-06187-z. Epub 2020 Jul 23. No abstract available.</citation>
    <PMID>32705292</PMID>
  </results_reference>
  <results_reference>
    <citation>Linke NJ, Fulcher BJ, Engeler DM, Anderson S, Bailey MJ, Bernard S, Board JV, Brodie D, Buhr H, Burrell AJC, Cooper DJ, Fan E, Fraser JF, Gattas DJ, Higgins AM, Hopper IK, Huckson S, Litton E, McGuinness SP, Nair P, Orford N, Parke RL, Pellegrino VA, Pilcher DV, Sheldrake J, Reddi BAJ, Stub D, Trapani TV, Udy AA, Hodgson CL; EXCEL Investigators. A survey of extracorporeal membrane oxygenation practice in 23 Australian adult intensive care units. Crit Care Resusc. 2020 Jun;22(2):166-170. No abstract available.</citation>
    <PMID>32389109</PMID>
  </results_reference>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>September 13, 2023</last_update_submitted>
  <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intensive Care</keyword>
  <keyword>Critical Care</keyword>
  <keyword>Extracorporeal Membrane Oxygenation</keyword>
  <keyword>Extracorporeal Life Support</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <!-- 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/NCT03793257
org study id: ANZIC-RC/CH003
nct id: NCT03793257
lead sponsor: 
collaborator: 
collaborator: 
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has dmc: No
is fda regulated drug: No
is fda regulated device: No
ECMO is associated with significant costs, risks and requires specialist training and
      expertise. EXCEL is a novel, high-quality, detailed prospective registry of patients
      requiring ECMO in Australia and New Zealand. The registry provides information on patient
      selection, complications, costs and patient reported outcome measures. EXCEL uses the
      Theoretical Domains Framework to identify evidence-practice gaps and explore barriers and
      enablers to tailor implementation of evidence
The aim of EXCEL is to generate a bi-national multidisciplinary network of integrated care
      for patients suffering acute cardiac or respiratory failure or cardiac arrest requiring
      extracorporeal membrane oxygenation (ECMO) to monitor long term outcomes and identify best
      practice.

      Each year around 130,000 Australians and New Zealanders are admitted to an intensive care
      unit (ICU). The sickest patients in the ICU who have severe failure of the heart or lungs may
      require an external machine to oxygenate their blood in addition to a mechanical ventilator.
      This intervention, called extracorporeal membrane oxygenation (ECMO), involves circulating
      all of the patient's blood through large cannulae to external machinery every minute. It has
      the capability of completely replacing a non-functioning heart or lungs for days to weeks on
      end. These critically ill patients who require ECMO are the sickest in the hospital with only
      42% hospital survival. The use of ECMO has doubled in Australia and New Zealand and globally
      over five years, and in the USA has increased by 433%.

      The use of ECMO is associated with significant costs and risks, and it requires specialist
      training and expertise. In order to prepare for the organisation of these complex
      interventions in the ICU across regions, the investigators need to have accurate data on
      patients undergoing ECMO. The investigators monitor and review current practice in ECMO
      services by providing robust binational registry data to service providers and clinicians
      with a closed-loop feedback system. EXCEL explores barriers and enablers to evidence-based
      care in ECMO services and providing a platform to embed clinical trials. The investigators
      will translate findings with greater capacity, reach, and impact to drive measureable change
      in practice and improve patient-centred outcomes.

      The EXCEL Partnership represents a novel, coordinated effort to create a high-quality,
      detailed, prospective registry of patients requiring ECMO at ECMO centres. A tailored,
      detailed ECMO registry (EXCEL) can be used to address specific safety concerns, clinical
      questions and process of care issues. As a result, EXCEL can be designed and implemented to
      answer new investigator-initiated, hypothesis-driven clinical questions.
observational model: Cohort
time perspective: Prospective
measure: Disability-free survival at 6 months, defined as alive and free of disability, measured with the World Health Organisation's Disability Assessment Schedule (WHODAS 2.0) score of <25%.
time frame: At 6 months from study enrolment
description: WHODAS 2.0 measured using a trained, blinded assessor via telephone interview. The WHODAS scores are calculated using the sum of the six domain scores. These domain scores are then converted to a metric score ranging from 0 to 100 (where 0= no disability; 100= full disability)
measure: Number of participants with adverse events including major bleeding up to 28 days after ECMO, infection, thrombosis (in the ECMO cannulae or in the patient) and limb ischaemia
time frame: Up to 28 days after ECMO initiation
description: All adverse events are recorded determined by treating clinician
measure: Healthcare utilization - caseload per centre
time frame: Up to 12 months from study enrolment
description: ECMO patient numbers (caseload per centre)
measure: Healthcare utilization - ECMO initiation timing
time frame: Up to 12 months from study enrolment
description: Timing of ECMO initiation by staff including an ECMO retrieval team
measure: Healthcare utilization - number of staff members required to manage ECMO
time frame: Up to 12 months from study enrolment
description: Staff numbers required for the provision of ECMO in ICU and the training required for these staff members to perform their role.
measure: Healthcare utilization - hospital length of stay
time frame: Up to 12 months from study enrolment
description: Hospital and in-patient rehabilitation length of stay including hospital readmissions and time spent in ICU
measure: Healthcare costs
time frame: Measured from ECMO commencement to hospital discharge until 6 months following hopsital admission.
description: Number of resources including staff and, equipment and blood products utilised whilst the patient was receiving hospital care until 6 months following hospital admission.
measure: Health-related quality of life at baseline, 6 and 12 months using the EQ5D-5L
time frame: At 6 and 12 months from study enrolment. Retrospective baseline measured at 6 months.
description: Measured using the EQ5D-5L, delivered by a trained, blinded assessor via telephone interview. The EQ5D includes an analogue scale that asks the patient to rate their health on a scale of 0 to 100. (Where 0= worst health imaginable; 100= best health imaginable)
measure: Number of patients with disability at 6 and 12 months
time frame: At 6 and 12 months from study enrolment
description: Measured using the WHODAS 2.0, delivered by a trained, blinded assessor via telephone interview
measure: Psychological function at 12 months
time frame: At 12 months from study enrolment
description: Measured using the EQ5D-5L, delivered by a trained, blinded assessor via telephone interview
measure: Return to work at 6 months
time frame: At 6 months from study enrolment
description: Return to work measured bu the WHODAS 2.0, delivered by a trained, blinded assessor via telephone interview
measure: Disability at baseline, 6 and 12 months
time frame: Measured at 6 and 12 months. Retrospective baseline disability measured at 6 months.
description: Patient reported disability using a disability scale, delivered by a trained, blinded assessor via telephone interview
measure: Activities of daily living at 6 and 12 months
time frame: Measured at 6 and 12 months
description: Activities of daily living measured at 6 and 12 month using the ADL and IADL, delivered by a trained, blinded assessor via telephone interview
measure: Cognitive function at 12 months
time frame: Measured at 12 months
description: Cognitive function measured at 12 months using the MOCA Blind, delivered by a trained, blinded assessor via telephone interview
measure: Number patients who survive to 12 months following ECMO initiation
time frame: At 12 months from study enrolment
description: Measured by Research Coordinators at each of the participating sites
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carol L Hodgson, PhD
role: Study Chair
affiliation: Australian and New Zealand Intensive Care Research Centre
last name: Carol L Hodgson, PhD
phone: +613 9903 0598
email: carol.hodgson@monash.edu
last name: Ben Fulcher
phone: +613 9903 0930
email: bentley.fulcher@monash.edu
facility: 
status: Recruiting
contact: 
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status: Recruiting
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status: Recruiting
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status: Active, not recruiting
facility: 
status: Recruiting
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facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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country: Australia
country: New Zealand
url: https://www.monash.edu/medicine/sphpm/excel/home
description: EXCEL Registry Website
citation: Hodgson CL, Higgins AM, Bailey MJ, Anderson S, Bernard S, Fulcher BJ, Koe D, Linke NJ, Board JV, Brodie D, Buhr H, Burrell AJC, Cooper DJ, Fan E, Fraser JF, Gattas DJ, Hopper IK, Huckson S, Litton E, McGuinness SP, Nair P, Orford N, Parke RL, Pellegrino VA, Pilcher DV, Sheldrake J, Reddi BAJ, Stub D, Trapani TV, Udy AA, Serpa Neto A; EXCEL Study Investigators on behalf of the International ECMO Network and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Incidence of death or disability at 6 months after extracorporeal membrane oxygenation in Australia: a prospective, multicentre, registry-embedded cohort study. Lancet Respir Med. 2022 Nov;10(11):1038-1048. doi: 10.1016/S2213-2600(22)00248-X. Epub 2022 Sep 26.
PMID: 36174613
citation: Fulcher BJ, Nicholson AJ, Linke NJ, Berkovic D, Hodgson CL; EXCEL Study Investigators and the International ECMO Network. The perceived barriers and facilitators to implementation of ECMO services in acute hospitals. Intensive Care Med. 2020 Nov;46(11):2115-2117. doi: 10.1007/s00134-020-06187-z. Epub 2020 Jul 23. No abstract available.
PMID: 32705292
citation: Linke NJ, Fulcher BJ, Engeler DM, Anderson S, Bailey MJ, Bernard S, Board JV, Brodie D, Buhr H, Burrell AJC, Cooper DJ, Fan E, Fraser JF, Gattas DJ, Higgins AM, Hopper IK, Huckson S, Litton E, McGuinness SP, Nair P, Orford N, Parke RL, Pellegrino VA, Pilcher DV, Sheldrake J, Reddi BAJ, Stub D, Trapani TV, Udy AA, Hodgson CL; EXCEL Investigators. A survey of extracorporeal membrane oxygenation practice in 23 Australian adult intensive care units. Crit Care Resusc. 2020 Jun;22(2):166-170. No abstract available.
PMID: 32389109
responsible party type: Sponsor
mesh term: Respiratory Insufficiency
mesh term: Critical Illness