Clinical trial NCT03793257: The EXCEL Registry of Patients Requiring ECMO
Official title: The EXCEL Registry: A Comprehensive Binational Registry on the Treatment and Outcomes of Patients Requiring ECMO
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critically Ill
Acute Respiratory Failure
Acute Heart Failure
Cardiac Arrest
Keywords: Intensive Care
Critical Care
Extracorporeal Membrane Oxygenation
Extracorporeal Life Support
Lead sponsor: Australian and New Zealand Intensive Care Research Centre
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
name: Extracorporeal Life Support Organization
name: National Heart Foundation, Australia
name: The Alfred
name: Barwon Health
name: Fiona Stanley Hospital
name: The Prince Charles Hospital
name: Royal Prince Alfred Hospital, Sydney, Australia
name: St Vincent's Hospital, Sydney
First posted: 2019-01-04
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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

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.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to adult hospitals and receive ECMO in Australia and New Zealand

Nil Exclusion Criteria

Primary outcomes:
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%.
timeFrame: At 6 months from study enrolment
Secondary outcomes:
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
timeFrame: Up to 28 days after ECMO initiation
measure: Healthcare utilization - caseload per centre
timeFrame: Up to 12 months from study enrolment
measure: Healthcare utilization - ECMO initiation timing
timeFrame: Up to 12 months from study enrolment
measure: Healthcare utilization - number of staff members required to manage ECMO
timeFrame: Up to 12 months from study enrolment
measure: Healthcare utilization - hospital length of stay
timeFrame: Up to 12 months from study enrolment
measure: Healthcare costs
timeFrame: Measured from ECMO commencement to hospital discharge until 6 months following hopsital admission.
measure: Health-related quality of life at baseline, 6 and 12 months using the EQ5D-5L
timeFrame: At 6 and 12 months from study enrolment. Retrospective baseline measured at 6 months.
measure: Number of patients with disability at 6 and 12 months
timeFrame: At 6 and 12 months from study enrolment
measure: Psychological function at 12 months
timeFrame: At 12 months from study enrolment
measure: Return to work at 6 months
timeFrame: At 6 months from study enrolment
measure: Disability at baseline, 6 and 12 months
timeFrame: Measured at 6 and 12 months. Retrospective baseline disability measured at 6 months.
measure: Activities of daily living at 6 and 12 months
timeFrame: Measured at 6 and 12 months
measure: Cognitive function at 12 months
timeFrame: Measured at 12 months
measure: Number patients who survive to 12 months following ECMO initiation
timeFrame: At 12 months from study enrolment
Other outcomes:
Locations:
city: Canberra
country: Australia
facility: Canberra Hospital
state: Australian Capital Territory
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Newcastle
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Sydney
country: Australia
facility: St George Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Chermside
country: Australia
facility: Prince Charles Hospital
state: Queensland
city: Southport
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Sunshine Coast
country: Australia
facility: Sunshine Coast University Hospital
state: Queensland
city: Townsville
country: Australia
facility: Townsville Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hosptial
state: South Australia
city: Adelaide
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Launceston
country: Australia
facility: Launceston General Hospital
state: Tasmania
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Geelong
country: Australia
facility: University Hospital Geelong
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Richmond
country: Australia
facility: Epworth Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Perth
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Auckland
country: New Zealand
facility: Auckland City hospital
Study officials:
affiliation: Australian and New Zealand Intensive Care Research Centre
name: Carol L Hodgson, PhD
role: STUDY_CHAIR
References:
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: 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: 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.