The EXCEL Registry of Patients Requiring ECMO
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAustralian and New Zealand Intensive Care Research Centre
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients admitted to adult hospitals and receive ECMO in Australia and New Zealand
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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)
Time frame
At 6 months from study enrolmentSecondary 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
All adverse events are recorded determined by treating clinician
Time frame
Up to 28 days after ECMO initiation2
Healthcare utilization - caseload per centre
ECMO patient numbers (caseload per centre)
Time frame
Up to 12 months from study enrolment3
Healthcare utilization - ECMO initiation timing
Timing of ECMO initiation by staff including an ECMO retrieval team
Time frame
Up to 12 months from study enrolment4
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.
Time frame
Up to 12 months from study enrolmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Australian and New Zealand Intensive Care Research Centre
Lead sponsor
National Health and Medical Research Council, Australia
Collaborator
Extracorporeal Life Support Organization
Collaborator
National Heart Foundation, Australia
Collaborator
The Alfred
Collaborator
Barwon Health
Collaborator
Fiona Stanley Hospital
Collaborator
The Prince Charles Hospital
Collaborator
Royal Prince Alfred Hospital, Sydney, Australia
Collaborator
St Vincent's Hospital, Sydney
Collaborator
Source ClinicalTrials.gov