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Critically IllNCT03793257

The EXCEL Registry of Patients Requiring ECMO

An observational study of Critically Ill and Acute Respiratory Failure, run by Australian and New Zealand Intensive Care Research Centre at 29 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
3,000 participants
Where
29 sitesin 2 countries
Study dates
1 Feb 2019to 31 Dec 2027
How long will I take part?
12 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients admitted to hospitals with a primary diagnosis of acute heart failure, respiratory failure or cardiac arrest and received ECMO at participating ECMO centres.

Who may be able to join

  • Patients admitted to adult hospitals and receive ECMO in Australia and New Zealand
  • Nil Exclusion Criteria

Who cannot join

None listed.

Trial locations and contacts

29 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Carol L Hodgson, PhD contact

+613 9903 0598

carol.hodgson@monash.edu

Ben Fulcher contact

+613 9903 0930

bentley.fulcher@monash.edu

29 sites in 2 countries

Australia28 sites, 27 recruiting

  • Royal Adelaide Hosptial

    Adelaide, South Australia, 5000

    benjamin.reddi@sa.gov.au

    Benjamin Reddi, MD

    Recruiting

  • Flinders Medical Centre

    Adelaide, South Australia, 5042

    biharishailesh@gmail.com

    Shailesh Bihari, MD

    Recruiting

  • Box Hill Hospital

    Box Hill, Victoria, 3128

    john.dyett@easternhealth.org.au

    John Dyett, MD

    Recruiting

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4029

    jason.pincus@health.qld.gov.au

    Jason Pincus, MD

    Recruiting

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102

    james.walsham@health.qld.gov.au

    James Walsham, MD

    Recruiting

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

    richard.totaro@health.nsw.gov.au

    Richard Totaro, MD

    Recruiting

  • Canberra Hospital

    Canberra, Australian Capital Territory, 2605

    hemanth.veerendra@act.gov.au

    Hemanth Veerendra, MD

    Recruiting

  • Prince Charles Hospital

    Chermside, Queensland, 4032

    fraserjohn001@gmail.com

    Jayshree Lavana, MD

    Recruiting

  • Monash Medical Centre

    Clayton, Victoria, 3168

    brendan.murfin@monashhealth.org

    Brendan Murfin, MD

    Recruiting

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

    pnair@svha.org.au

    Priya Nair, MD

    Recruiting

  • University Hospital Geelong

    Geelong, Victoria

    joemccaffrey77@gmail.com

    Joe McCaffrey, MD

    Recruiting

  • Austin Health

    Heidelberg, Victoria, 3084

    rinaldo.bellomo@austin.org.au

    Rinaldo Bellomo, MD

    Recruiting

  • Launceston General Hospital

    Launceston, Tasmania, 7250

    matt.brain@ths.tas.gov.au

    Matthew Brain, MD

    Recruiting

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

    peter.mccanny@health.nsw.gov.au

    Peter McCanny, MD

    Recruiting

  • The Alfred Hospital

    Melbourne, Victoria, 3004

    v.pellegrino@alfred.org.au

    Vincent Pellegrino, MD

    Recruiting

  • St Vincent's Hospital Melbourne

    Melbourne, Victoria, 3065

    yvette.obrien@svha.org.au

    Yvette O'Brien, MD

    Recruiting

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

    stephen.richards@health.wa.gov.au

    Steve Richards, MD

    Recruiting

  • John Hunter Hospital

    Newcastle, New South Wales, 2305

    jorge.brieva@hnehealth.nsw.gov.au

    Jorge Brieva, MD

    Recruiting

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

    james.anstey@mh.org.au

    James Anstey, MD

    Recruiting

  • Fiona Stanley Hospital

    Perth, Western Australia, 6150

    chris.allen@health.wa.gov.au

    Chris Allen, MD

    Recruiting

  • Epworth Hospital

    Richmond, Victoria

    kyle.brooks@epworth.org.au

    Kyle Brooks, MD

    Recruiting

  • Gold Coast University Hospital

    Southport, Queensland

    james.winearls@health.qld.gov.au

    James Winearls, MD

    Recruiting

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

    pjanin@skmx.net

    Pierre Janin

    Recruiting

  • Sunshine Coast University Hospital

    Sunshine Coast, Queensland, 4575

    Active, not recruiting

  • Prince of Wales Hospital

    Sydney, New South Wales, 2031

    gavin.salt@health.nsw.gov.au

    Gavin Salt, MD

    Recruiting

  • St George Hospital

    Sydney, New South Wales, 2217

    c.slawomirski@gmail.com

    Christof Slawomirski, MD

    Recruiting

  • Townsville Hospital

    Townsville, Queensland, 4814

    april.win@health.qld.gov.au

    April Win, MD

    Recruiting

  • Westmead Hospital

    Westmead, New South Wales, 2145

    benjamin.davidson@health.nsw.gov.au

    Benjamin Davidson, MD

    Recruiting

Other trials in Australia

New Zealand1 site, 1 recruiting

  • Auckland City hospital

    Auckland, 1023

    shaymc@adhb.govt.nz

    Shay McGuinness, MD

    Recruiting

Other trials in New Zealand

About this study

Official title: The EXCEL Registry: A Comprehensive Binational Registry on the Treatment and Outcomes of Patients Requiring ECMO

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

Read the detailed description

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.

Keywords
Intensive Care, Critical Care, Extracorporeal Membrane Oxygenation, Extracorporeal Life Support
Medical subject headings
Critical Illness, Heart Arrest

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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%.

    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)

    Measured: At 6 months from study enrolment

Secondary outcomes (14)

  1. 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

    All adverse events are recorded determined by treating clinician

    Measured: Up to 28 days after ECMO initiation

  2. Healthcare utilization - caseload per centre

    ECMO patient numbers (caseload per centre)

    Measured: Up to 12 months from study enrolment

  3. Healthcare utilization - ECMO initiation timing

    Timing of ECMO initiation by staff including an ECMO retrieval team

    Measured: Up to 12 months from study enrolment

  4. Healthcare utilization - number of staff members required to manage ECMO

    Staff numbers required for the provision of ECMO in ICU and the training required for these staff members to perform their role.

    Measured: Up to 12 months from study enrolment

  5. Healthcare utilization - hospital length of stay

    Hospital and in-patient rehabilitation length of stay including hospital readmissions and time spent in ICU

    Measured: Up to 12 months from study enrolment

  6. Healthcare costs

    Number of resources including staff and, equipment and blood products utilised whilst the patient was receiving hospital care until 6 months following hospital admission.

    Measured: Measured from ECMO commencement to hospital discharge until 6 months following hopsital admission.

  7. Health-related quality of life at baseline, 6 and 12 months using the EQ5D-5L

    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)

    Measured: At 6 and 12 months from study enrolment. Retrospective baseline measured at 6 months.

  8. Number of patients with disability at 6 and 12 months

    Measured using the WHODAS 2.0, delivered by a trained, blinded assessor via telephone interview

    Measured: At 6 and 12 months from study enrolment

  9. Psychological function at 12 months

    Measured using the EQ5D-5L, delivered by a trained, blinded assessor via telephone interview

    Measured: At 12 months from study enrolment

  10. Return to work at 6 months

    Return to work measured bu the WHODAS 2.0, delivered by a trained, blinded assessor via telephone interview

    Measured: At 6 months from study enrolment

  11. Disability at baseline, 6 and 12 months

    Patient reported disability using a disability scale, delivered by a trained, blinded assessor via telephone interview

    Measured: Measured at 6 and 12 months. Retrospective baseline disability measured at 6 months.

  12. Activities of daily living at 6 and 12 months

    Activities of daily living measured at 6 and 12 month using the ADL and IADL, delivered by a trained, blinded assessor via telephone interview

    Measured: Measured at 6 and 12 months

  13. Cognitive function at 12 months

    Cognitive function measured at 12 months using the MOCA Blind, delivered by a trained, blinded assessor via telephone interview

    Measured: Measured at 12 months

  14. Number patients who survive to 12 months following ECMO initiation

    Measured by Research Coordinators at each of the participating sites

    Measured: At 12 months from study enrolment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2019
  2. Study start1 Feb 2019
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,000 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03793257
Sponsor's protocol ID
ANZIC-RC/CH003
Status last verified
Sep 2023
First submitted
17 Dec 2018
Last updated
15 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36174613

  • 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.

    PubMed 32705292

  • 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. doi: 10.51893/2020.2.sur7. No abstract available.

    PubMed 32389109

  • Wilcox KR, Meredith L, Burrell A, Fulcher B, Hodgson CL, Higgins AM; EXCEL management committee. Costs and complications of extracorporeal membrane oxygenation therapy in Australia and New Zealand. Crit Care. 2026 May 20;30(1):282. doi: 10.1186/s13054-026-06086-7.

    PubMed 42163394

  • Brown A, Dennis M, Rattan N, Nanjayya V, Burrell A, Serpa Neto A, Hodgson C; EXCEL (a Comprehensive Binational Registry on the Treatment and Outcomes of Patients Requiring Extracorporeal Membrane Oxygenation [ECMO]) Study Investigators and the International ECMO Network. Neurologic Complications During Venoarterial Extracorporeal Membrane Oxygenation and Their Implications for 6-Month Patient-Centered Outcomes. Crit Care Med. 2026 Jan 1;54(1):175-186. doi: 10.1097/CCM.0000000000006938. Epub 2025 Nov 10.

    PubMed 41212045

  • Serpa Neto A, Higgins AM, Bailey MJ, Anderson S, Bernard S, Fulcher BJ, Jones A, 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, Dicker C, Reddi BAJ, Stub D, Trapani TV, Udy AA, Hodgson CL; EXCEL Study Investigators on behalf of the International ECMO Network (ECMONet). Long-Term Functional Outcomes in the First 12 Months After VA-ECMO in Adult Patients: A Prospective, Multicenter Study. Circ Heart Fail. 2025 Jun;18(6):e012476. doi: 10.1161/CIRCHEARTFAILURE.124.012476. Epub 2025 Apr 29.

    PubMed 40298907

Questions about this trial

What is this clinical trial studying?

An observational study of Critically Ill and Acute Respiratory Failure, run by Australian and New Zealand Intensive Care Research Centre at 29 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carol L Hodgson, PhD (+613 9903 0598, carol.hodgson@monash.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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 <25%. (time frame: At 6 months from study enrolment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03793257, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.

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