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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03793257
Registration number
NCT03793257
Ethics application status
Date submitted
17/12/2018
Date registered
4/01/2019
Date last updated
15/09/2023
Titles & IDs
Public title
The EXCEL Registry of Patients Requiring ECMO
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Scientific title
The EXCEL Registry: A Comprehensive Binational Registry on the Treatment and Outcomes of Patients Requiring ECMO
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Secondary ID [1]
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ANZIC-RC/CH003
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Critically Ill
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Acute Respiratory Failure
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Acute Heart Failure
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Cardiac Arrest
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Condition category
Condition code
Respiratory
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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%.
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Assessment method [1]
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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)
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Timepoint [1]
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At 6 months from study enrolment
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Secondary outcome [1]
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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
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Assessment method [1]
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All adverse events are recorded determined by treating clinician
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Timepoint [1]
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Up to 28 days after ECMO initiation
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Secondary outcome [2]
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Healthcare utilization - caseload per centre
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Assessment method [2]
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ECMO patient numbers (caseload per centre)
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Timepoint [2]
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Up to 12 months from study enrolment
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Secondary outcome [3]
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Healthcare utilization - ECMO initiation timing
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Assessment method [3]
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Timing of ECMO initiation by staff including an ECMO retrieval team
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Timepoint [3]
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Up to 12 months from study enrolment
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Secondary outcome [4]
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Healthcare utilization - number of staff members required to manage ECMO
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Assessment method [4]
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Staff numbers required for the provision of ECMO in ICU and the training required for these staff members to perform their role.
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Timepoint [4]
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Up to 12 months from study enrolment
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Secondary outcome [5]
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Healthcare utilization - hospital length of stay
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Assessment method [5]
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Hospital and in-patient rehabilitation length of stay including hospital readmissions and time spent in ICU
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Timepoint [5]
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Up to 12 months from study enrolment
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Secondary outcome [6]
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Healthcare costs
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Assessment method [6]
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Number of resources including staff and, equipment and blood products utilised whilst the patient was receiving hospital care until 6 months following hospital admission.
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Timepoint [6]
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Measured from ECMO commencement to hospital discharge until 6 months following hopsital admission.
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Secondary outcome [7]
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Health-related quality of life at baseline, 6 and 12 months using the EQ5D-5L
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Assessment method [7]
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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)
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Timepoint [7]
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At 6 and 12 months from study enrolment. Retrospective baseline measured at 6 months.
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Secondary outcome [8]
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Number of patients with disability at 6 and 12 months
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Assessment method [8]
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Measured using the WHODAS 2.0, delivered by a trained, blinded assessor via telephone interview
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Timepoint [8]
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At 6 and 12 months from study enrolment
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Secondary outcome [9]
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Psychological function at 12 months
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Assessment method [9]
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Measured using the EQ5D-5L, delivered by a trained, blinded assessor via telephone interview
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Timepoint [9]
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At 12 months from study enrolment
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Secondary outcome [10]
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Return to work at 6 months
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Assessment method [10]
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Return to work measured bu the WHODAS 2.0, delivered by a trained, blinded assessor via telephone interview
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Timepoint [10]
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At 6 months from study enrolment
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Secondary outcome [11]
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Disability at baseline, 6 and 12 months
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Assessment method [11]
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Patient reported disability using a disability scale, delivered by a trained, blinded assessor via telephone interview
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Timepoint [11]
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Measured at 6 and 12 months. Retrospective baseline disability measured at 6 months.
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Secondary outcome [12]
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Activities of daily living at 6 and 12 months
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Assessment method [12]
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Activities of daily living measured at 6 and 12 month using the ADL and IADL, delivered by a trained, blinded assessor via telephone interview
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Timepoint [12]
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Measured at 6 and 12 months
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Secondary outcome [13]
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Cognitive function at 12 months
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Assessment method [13]
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Cognitive function measured at 12 months using the MOCA Blind, delivered by a trained, blinded assessor via telephone interview
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Timepoint [13]
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Measured at 12 months
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Secondary outcome [14]
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Number patients who survive to 12 months following ECMO initiation
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Assessment method [14]
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Measured by Research Coordinators at each of the participating sites
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Timepoint [14]
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At 12 months from study enrolment
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Eligibility
Key inclusion criteria
- Patients admitted to adult hospitals and receive ECMO in Australia and New Zealand
Nil
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2027
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Actual
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Sample size
Target
3000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Canberra Hospital - Canberra
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Recruitment hospital [2]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [3]
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St Vincent's Hospital Sydney - Darlinghurst
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Recruitment hospital [4]
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Liverpool Hospital - Liverpool
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Recruitment hospital [5]
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John Hunter Hospital - Newcastle
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Recruitment hospital [6]
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [7]
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Prince of Wales Hospital - Sydney
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Recruitment hospital [8]
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St George Hospital - Sydney
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Recruitment hospital [9]
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Westmead Hospital - Westmead
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Recruitment hospital [10]
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Royal Brisbane and Women's Hospital - Brisbane
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Recruitment hospital [11]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [12]
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Prince Charles Hospital - Chermside
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Recruitment hospital [13]
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Gold Coast University Hospital - Southport
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Recruitment hospital [14]
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Sunshine Coast University Hospital - Sunshine Coast
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Recruitment hospital [15]
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Townsville Hospital - Townsville
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Recruitment hospital [16]
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Royal Adelaide Hosptial - Adelaide
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Recruitment hospital [17]
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Flinders Medical Centre - Adelaide
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Recruitment hospital [18]
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Launceston General Hospital - Launceston
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Recruitment hospital [19]
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Box Hill Hospital - Box Hill
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Recruitment hospital [20]
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Monash Medical Centre - Clayton
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Recruitment hospital [21]
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University Hospital Geelong - Geelong
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Recruitment hospital [22]
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Austin Health - Heidelberg
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Recruitment hospital [23]
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The Alfred Hospital - Melbourne
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Recruitment hospital [24]
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St Vincent's Hospital Melbourne - Melbourne
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Recruitment hospital [25]
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Royal Melbourne Hospital - Parkville
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Recruitment hospital [26]
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Epworth Hospital - Richmond
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Recruitment hospital [27]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment hospital [28]
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Fiona Stanley Hospital - Perth
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Recruitment postcode(s) [1]
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2605 - Canberra
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment postcode(s) [3]
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2010 - Darlinghurst
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Recruitment postcode(s) [4]
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2170 - Liverpool
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Recruitment postcode(s) [5]
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2305 - Newcastle
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Recruitment postcode(s) [6]
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2065 - St Leonards
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Recruitment postcode(s) [7]
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2031 - Sydney
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Recruitment postcode(s) [8]
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2217 - Sydney
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Recruitment postcode(s) [9]
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2145 - Westmead
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Recruitment postcode(s) [10]
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4029 - Brisbane
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Recruitment postcode(s) [11]
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4102 - Brisbane
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Recruitment postcode(s) [12]
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4032 - Chermside
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Recruitment postcode(s) [13]
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- Southport
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Recruitment postcode(s) [14]
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4575 - Sunshine Coast
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Recruitment postcode(s) [15]
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4814 - Townsville
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Recruitment postcode(s) [16]
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5000 - Adelaide
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Recruitment postcode(s) [17]
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5042 - Adelaide
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Recruitment postcode(s) [18]
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7250 - Launceston
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Recruitment postcode(s) [19]
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3128 - Box Hill
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Recruitment postcode(s) [20]
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3168 - Clayton
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Recruitment postcode(s) [21]
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- Geelong
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Recruitment postcode(s) [22]
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3084 - Heidelberg
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Recruitment postcode(s) [23]
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3004 - Melbourne
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Recruitment postcode(s) [24]
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3065 - Melbourne
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Recruitment postcode(s) [25]
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3050 - Parkville
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Recruitment postcode(s) [26]
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- Richmond
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Recruitment postcode(s) [27]
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6009 - Nedlands
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Recruitment postcode(s) [28]
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6150 - Perth
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Other
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Name
Australian and New Zealand Intensive Care Research Centre
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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National Health and Medical Research Council, Australia
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Address [1]
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0
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Country [1]
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0
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Other collaborator category [2]
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Other
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Name [2]
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Extracorporeal Life Support Organization
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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National Heart Foundation, Australia
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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The Alfred
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Address [4]
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Country [4]
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Other collaborator category [5]
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Other
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Name [5]
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Barwon Health
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Address [5]
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Country [5]
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Other collaborator category [6]
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Other
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Name [6]
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Fiona Stanley Hospital
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Address [6]
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Country [6]
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Other collaborator category [7]
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Other
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Name [7]
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The Prince Charles Hospital
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Address [7]
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Country [7]
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Other collaborator category [8]
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Other
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Name [8]
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Royal Prince Alfred Hospital, Sydney, Australia
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Address [8]
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Country [8]
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Other collaborator category [9]
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Other
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Name [9]
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St Vincent's Hospital, Sydney
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Address [9]
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Country [9]
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03793257
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Carol L Hodgson, PhD
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Address
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Australian and New Zealand Intensive Care Research Centre
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Carol L Hodgson, PhD
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Address
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Country
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Phone
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+613 9903 0598
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03793257
Download to PDF