The EXCEL Registry of Patients Requiring ECMO

Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03793257
• Other study ID #: ANZIC-RC/CH003
• Status: Recruiting
• Start date: February 1, 2019
• Est. completion date: December 31, 2027

Study information

• Verified date: September 2023
• Source: Australian and New Zealand Intensive Care Research Centre
• Contact: Carol L Hodgson, PhD
• Phone: +613 9903 0598
• Email: carol.hodgson[@]monash.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Acute Heart Failure
• Acute Respiratory Failure
• Cardiac Arrest
• Critical Illness
• Critically Ill
• Respiratory Insufficiency

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Adelaide	South Australia
Australia	Royal Adelaide Hosptial	Adelaide	South Australia
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	Royal Brisbane and Women's Hospital	Brisbane	Queensland
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Canberra Hospital	Canberra	Australian Capital Territory
Australia	Prince Charles Hospital	Chermside	Queensland
Australia	Monash Medical Centre	Clayton	Victoria
Australia	St Vincent's Hospital Sydney	Darlinghurst	New South Wales
Australia	University Hospital Geelong	Geelong	Victoria
Australia	Austin Health	Heidelberg	Victoria
Australia	Launceston General Hospital	Launceston	Tasmania
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	St Vincent's Hospital Melbourne	Melbourne	Victoria
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	John Hunter Hospital	Newcastle	New South Wales
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	Fiona Stanley Hospital	Perth	Western Australia
Australia	Epworth Hospital	Richmond	Victoria
Australia	Gold Coast University Hospital	Southport	Queensland
Australia	Royal North Shore Hospital	St Leonards	New South Wales
Australia	Sunshine Coast University Hospital	Sunshine Coast	Queensland
Australia	Prince of Wales Hospital	Sydney	New South Wales
Australia	St George Hospital	Sydney	New South Wales
Australia	Townsville Hospital	Townsville	Queensland
Australia	Westmead Hospital	Westmead	New South Wales
New Zealand	Auckland City hospital	Auckland

Sponsors (10)

Lead Sponsor	Collaborator
Australian and New Zealand Intensive Care Research Centre	Barwon Health, Extracorporeal Life Support Organization, Fiona Stanley Hospital, National Health and Medical Research Council, Australia, National Heart Foundation, Australia, Royal Prince Alfred Hospital, Sydney, Australia, St Vincent's Hospital, Sydney, The Alfred, The Prince Charles Hospital

Countries where clinical trial is conducted

Australia,  New Zealand, 

References & Publications (3)

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):21 — View 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 V — View 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, Pilc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	At 6 months from study enrolment
Secondary	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	Up to 28 days after ECMO initiation
Secondary	Healthcare utilization - caseload per centre	ECMO patient numbers (caseload per centre)	Up to 12 months from study enrolment
Secondary	Healthcare utilization - ECMO initiation timing	Timing of ECMO initiation by staff including an ECMO retrieval team	Up to 12 months from study enrolment
Secondary	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.	Up to 12 months from study enrolment
Secondary	Healthcare utilization - hospital length of stay	Hospital and in-patient rehabilitation length of stay including hospital readmissions and time spent in ICU	Up to 12 months from study enrolment
Secondary	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 from ECMO commencement to hospital discharge until 6 months following hopsital admission.
Secondary	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)	At 6 and 12 months from study enrolment. Retrospective baseline measured at 6 months.
Secondary	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	At 6 and 12 months from study enrolment
Secondary	Psychological function at 12 months	Measured using the EQ5D-5L, delivered by a trained, blinded assessor via telephone interview	At 12 months from study enrolment
Secondary	Return to work at 6 months	Return to work measured bu the WHODAS 2.0, delivered by a trained, blinded assessor via telephone interview	At 6 months from study enrolment
Secondary	Disability at baseline, 6 and 12 months	Patient reported disability using a disability scale, delivered by a trained, blinded assessor via telephone interview	Measured at 6 and 12 months. Retrospective baseline disability measured at 6 months.
Secondary	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 at 6 and 12 months
Secondary	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 at 12 months
Secondary	Number patients who survive to 12 months following ECMO initiation	Measured by Research Coordinators at each of the participating sites	At 12 months from study enrolment

External Links

•   EXCEL Registry Website