NCT03793257

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
21mo left

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
2 countries

29 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Feb 2019Dec 2027

First Submitted

Initial submission to the registry

December 17, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

7.9 years

First QC Date

December 17, 2018

Last Update Submit

September 13, 2023

Conditions

Critically IllAcute Respiratory FailureAcute Heart FailureCardiac Arrest

Keywords

Intensive CareCritical CareExtracorporeal Membrane OxygenationExtracorporeal Life Support

Outcome Measures

Primary Outcomes (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)

    At 6 months from study enrolment

Secondary Outcomes (14)

  • 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

    Up to 28 days after ECMO initiation

  • Healthcare utilization - caseload per centre

    Up to 12 months from study enrolment

  • Healthcare utilization - ECMO initiation timing

    Up to 12 months from study enrolment

  • Healthcare utilization - number of staff members required to manage ECMO

    Up to 12 months from study enrolment

  • Healthcare utilization - hospital length of stay

    Up to 12 months from study enrolment

  • +9 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Canberra Hospital

Canberra, Australian Capital Territory, 2605, Australia

RECRUITING

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

RECRUITING

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

RECRUITING

John Hunter Hospital

Newcastle, New South Wales, 2305, Australia

RECRUITING

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

RECRUITING

Prince of Wales Hospital

Sydney, New South Wales, 2031, Australia

RECRUITING

St George Hospital

Sydney, New South Wales, 2217, Australia

RECRUITING

Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

RECRUITING

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

RECRUITING

Prince Charles Hospital

Chermside, Queensland, 4032, Australia

RECRUITING

Gold Coast University Hospital

Southport, Queensland, Australia

RECRUITING

Sunshine Coast University Hospital

Sunshine Coast, Queensland, 4575, Australia

ACTIVE NOT RECRUITING

Townsville Hospital

Townsville, Queensland, 4814, Australia

RECRUITING

Royal Adelaide Hosptial

Adelaide, South Australia, 5000, Australia

RECRUITING

Flinders Medical Centre

Adelaide, South Australia, 5042, Australia

RECRUITING

Launceston General Hospital

Launceston, Tasmania, 7250, Australia

RECRUITING

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

RECRUITING

Monash Medical Centre

Clayton, Victoria, 3168, Australia

RECRUITING

University Hospital Geelong

Geelong, Victoria, Australia

RECRUITING

Austin Health

Heidelberg, Victoria, 3084, Australia

RECRUITING

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

St Vincent's Hospital Melbourne

Melbourne, Victoria, 3065, Australia

RECRUITING

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

RECRUITING

Epworth Hospital

Richmond, Victoria, Australia

RECRUITING

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

RECRUITING

Fiona Stanley Hospital

Perth, Western Australia, 6150, Australia

RECRUITING

Auckland City hospital

Auckland, 1023, New Zealand

RECRUITING

Related Publications (5)

  • 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: 36174613RESULT

  • 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: 32705292RESULT

  • 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.

    PMID: 32389109RESULT

  • 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.

    PMID: 41212045DERIVED

  • 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.

    PMID: 40298907DERIVED

Related Links

MeSH Terms

Conditions

Critical IllnessHeart Arrest

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Study Officials

  • Carol L Hodgson, PhD

    Australian and New Zealand Intensive Care Research Centre

    STUDY CHAIR

Central Study Contacts

Carol L Hodgson, PhD

CONTACT

+613 9903 0598carol.hodgson@monash.edu

Ben Fulcher

CONTACT

+613 9903 0930bentley.fulcher@monash.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2018

First Posted

January 4, 2019

Study Start

February 1, 2019

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

September 15, 2023

Record last verified: 2023-09

Locations

AU(28)NZ(1)