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NCT Number: NCT03793257

The EXCEL Registry 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

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Key information

Conditions

Critically Ill Acute Heart Failure Acute Respiratory Failure Cardiac Arrest Cardiovascular Diseases Critical Illness Disease Attributes Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Canberra Hospital, Canberra, Australian Capital Territory, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Nil Exclusion Criteria

Treatment and study plan

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%.

    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)

Secondary outcomes

  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

    Time frame: Up to 28 days after ECMO initiation

    All adverse events are recorded determined by treating clinician

  2. Healthcare utilization - caseload per centre

    Time frame: Up to 12 months from study enrolment

    ECMO patient numbers (caseload per centre)

  3. 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

  4. 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.

  5. 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

  6. 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.

  7. 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)

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ben Fulcher

CONTACT

[email protected]

+613 9903 0930

Carol L Hodgson, PhD

CONTACT

[email protected]

+613 9903 0598

Sponsors and collaborators

Lead sponsor

Australian and New Zealand Intensive Care Research Centre

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Jan 4, 2019
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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