The EXCEL Registry of Patients Requiring ECMO

September 13, 2023 updated by: Australian and New Zealand Intensive Care Research Centre

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

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia, 2605
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
      • Darlinghurst, New South Wales, Australia, 2010
        • Recruiting
        • St Vincent's Hospital Sydney
        • Principal Investigator:
          • Priya Nair, MD
        • Contact:
      • Liverpool, New South Wales, Australia, 2170
      • Newcastle, New South Wales, Australia, 2305
      • St Leonards, New South Wales, Australia, 2065
        • Recruiting
        • Royal North Shore Hospital
        • Contact:
        • Principal Investigator:
          • Pierre Janin
      • Sydney, New South Wales, Australia, 2031
      • Sydney, New South Wales, Australia, 2217
        • Recruiting
        • St George Hospital
        • Contact:
        • Principal Investigator:
          • Christof Slawomirski, MD
      • Westmead, New South Wales, Australia, 2145
    • Queensland
      • Brisbane, Queensland, Australia, 4102
      • Brisbane, Queensland, Australia, 4029
      • Chermside, Queensland, Australia, 4032
        • Recruiting
        • Prince Charles Hospital
        • Sub-Investigator:
          • Jayshree Lavana, MD
        • Contact:
        • Principal Investigator:
          • John Fraser, MD
      • Southport, Queensland, Australia
      • Sunshine Coast, Queensland, Australia, 4575
        • Active, not recruiting
        • Sunshine Coast University Hospital
      • Townsville, Queensland, Australia, 4814
    • South Australia
      • Adelaide, South Australia, Australia, 5042
        • Recruiting
        • Flinders Medical Centre
        • Contact:
        • Principal Investigator:
          • Shailesh Bihari, MD
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hosptial
        • Contact:
        • Principal Investigator:
          • Benjamin Reddi, MD
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
    • Victoria
      • Box Hill, Victoria, Australia, 3128
      • Clayton, Victoria, Australia, 3168
      • Geelong, Victoria, Australia
        • Recruiting
        • University Hospital Geelong
        • Contact:
        • Principal Investigator:
          • Joe McCaffrey, MD
      • Heidelberg, Victoria, Australia, 3084
      • Melbourne, Victoria, Australia, 3004
      • Melbourne, Victoria, Australia, 3065
        • Recruiting
        • St Vincent's Hospital Melbourne
        • Contact:
        • Principal Investigator:
          • Yvette O'Brien, MD
      • Parkville, Victoria, Australia, 3050
        • Recruiting
        • Royal Melbourne Hospital
        • Contact:
        • Principal Investigator:
          • James Anstey, MD
      • Richmond, Victoria, Australia
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
      • Perth, Western Australia, Australia, 6150
  • New Zealand
      • Auckland, New Zealand, 1023
        • Recruiting
        • Auckland City Hospital
        • Contact:
        • Principal Investigator:
          • Shay McGuinness, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Nil Exclusion Criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
All adverse events are recorded determined by treating clinician
Up to 28 days after ECMO initiation
Healthcare utilization - ECMO initiation timing
Time Frame: Up to 12 months from study enrolment
Timing of ECMO initiation by staff including an ECMO retrieval team
Up to 12 months from study enrolment
Healthcare utilization - hospital length of stay
Time Frame: Up to 12 months from study enrolment
Hospital and in-patient rehabilitation length of stay including hospital readmissions and time spent in ICU
Up to 12 months from study enrolment
Healthcare costs
Time Frame: Measured from ECMO commencement to hospital discharge until 6 months following hopsital admission.
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.
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.
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.
Number of patients with disability at 6 and 12 months
Time Frame: At 6 and 12 months from study enrolment
Measured using the WHODAS 2.0, delivered by a trained, blinded assessor via telephone interview
At 6 and 12 months from study enrolment
Psychological function at 12 months
Time Frame: At 12 months from study enrolment
Measured using the EQ5D-5L, delivered by a trained, blinded assessor via telephone interview
At 12 months from study enrolment
Return to work at 6 months
Time Frame: At 6 months from study enrolment
Return to work measured bu the WHODAS 2.0, delivered by a trained, blinded assessor via telephone interview
At 6 months from study enrolment
Disability at baseline, 6 and 12 months
Time Frame: Measured at 6 and 12 months. Retrospective baseline disability measured at 6 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.
Activities of daily living at 6 and 12 months
Time Frame: Measured 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
Cognitive function at 12 months
Time Frame: Measured 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
Number patients who survive to 12 months following ECMO initiation
Time Frame: At 12 months from study enrolment
Measured by Research Coordinators at each of the participating sites
At 12 months from study enrolment
Healthcare utilization - caseload per centre
Time Frame: Up to 12 months from study enrolment
ECMO patient numbers (caseload per centre)
Up to 12 months from study enrolment
Healthcare utilization - number of staff members required to manage ECMO
Time Frame: Up to 12 months from study enrolment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Australian and New Zealand Intensive Care Research Centre

Collaborators

National Health and Medical Research Council, Australia
The Alfred
National Heart Foundation, Australia
Barwon Health
St Vincent's Hospital, Sydney
Royal Prince Alfred Hospital, Sydney, Australia
The Prince Charles Hospital
Fiona Stanley Hospital
Extracorporeal Life Support Organization

Investigators

  • Study Chair: Carol L Hodgson, PhD, Australian and New Zealand Intensive Care Research Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 17, 2018

First Submitted That Met QC Criteria

January 2, 2019

First Posted (Actual)

January 4, 2019

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANZIC-RC/CH003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Arrest

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe