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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03793257




Registration number
NCT03793257
Ethics application status
Date submitted
17/12/2018
Date registered
4/01/2019
Date last updated
4/05/2020

Titles & IDs
Public title
The EXCEL Registry of Patients Requiring ECMO
Scientific title
The EXCEL Registry: A Comprehensive Binational Registry on the Treatment and Outcomes of Patients Requiring ECMO
Secondary ID [1] 0 0
ANZIC-RC/CH003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically Ill 0 0
Acute Respiratory Failure 0 0
Acute Heart Failure 0 0
Cardiac Arrest 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
At 6 months from study enrolment
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to 28 days after ECMO initiation
Secondary outcome [2] 0 0
Healthcare utilization -caseload per centre - ECMO patient numbers (caseload per centre)
Timepoint [2] 0 0
Up to 12 months from study enrolment
Secondary outcome [3] 0 0
Healthcare utilization - ECMO initiation timing - Timing of ECMO initiation by staff including an ECMO retrieval team
Timepoint [3] 0 0
Up to 12 months from study enrolment
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Up to 12 months from study enrolment
Secondary outcome [5] 0 0
Healthcare utilization - hospital length of stay - Hospital and in-patient rehabilitation length of stay including hospital readmissions and time spent in ICU
Timepoint [5] 0 0
Up to 12 months from study enrolment
Secondary outcome [6] 0 0
Healthcare costs - Number of resources including staff and, equipment and blood products utilised whilst the patient was receiving hospital care until 6 months following hospital admission.
Timepoint [6] 0 0
Measured from ECMO commencement to hospital discharge until 6 months following hopsital admission.
Secondary outcome [7] 0 0
Health-related quality of life at baseline, 6 and 12 months using the EQ5D-5L - 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)
Timepoint [7] 0 0
At 6 and 12 months from study enrolment. Retrospective baseline measured at 6 months.
Secondary outcome [8] 0 0
Number of patients with disability at 6 and 12 months - Measured using the WHODAS 2.0, delivered by a trained, blinded assessor via telephone interview
Timepoint [8] 0 0
At 6 and 12 months from study enrolment
Secondary outcome [9] 0 0
Psychological function at 12 months - Measured using the EQ5D-5L, delivered by a trained, blinded assessor via telephone interview
Timepoint [9] 0 0
At 12 months from study enrolment
Secondary outcome [10] 0 0
Return to work at 6 months - Return to work measured bu the WHODAS 2.0, delivered by a trained, blinded assessor via telephone interview
Timepoint [10] 0 0
At 6 months from study enrolment
Secondary outcome [11] 0 0
Disability at baseline, 6 and 12 months - Patient reported disability using a disability scale, delivered by a trained, blinded assessor via telephone interview
Timepoint [11] 0 0
Measured at 6 and 12 months. Retrospective baseline disability measured at 6 months.
Secondary outcome [12] 0 0
Activities of daily living 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
Timepoint [12] 0 0
Measured at 6 and 12 months
Secondary outcome [13] 0 0
Cognitive function at 12 months - Cognitive function measured at 12 months using the MOCA Blind, delivered by a trained, blinded assessor via telephone interview
Timepoint [13] 0 0
Measured at 12 months
Secondary outcome [14] 0 0
Number patients who survive to 12 months following ECMO initiation - Measured by Research Coordinators at each of the participating sites
Timepoint [14] 0 0
At 12 months from study enrolment

Eligibility
Key inclusion criteria
- Patients admitted to ICU and receive ECMO in Australia and New Zealand

- Patients aged 18 years or older

Nil
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,Bedford ParkNSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [3] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [4] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [5] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [6] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [7] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [8] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [9] 0 0
St George Hospital - Sydney
Recruitment hospital [10] 0 0
Westmead Hospital - Westmead
Recruitment hospital [11] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [12] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [13] 0 0
Prince Charles Hospital - Chermside
Recruitment hospital [14] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [15] 0 0
Royal Adelaide Hosptial - Adelaide
Recruitment hospital [16] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [17] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [18] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [19] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [20] 0 0
Frankston Hospital - Frankston
Recruitment hospital [21] 0 0
Geelong University Hospital - Geelong
Recruitment hospital [22] 0 0
Austin Health - Heidelberg
Recruitment hospital [23] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [24] 0 0
St Vincent's Hospital Melbourne - Melbourne
Recruitment hospital [25] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [26] 0 0
Epworth Hospital - Richmond
Recruitment hospital [27] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [28] 0 0
Fiona Stanley Hospital - Perth
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
5042 - Adelaide
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [5] 0 0
2170 - Liverpool
Recruitment postcode(s) [6] 0 0
2305 - Newcastle
Recruitment postcode(s) [7] 0 0
2065 - St Leonards
Recruitment postcode(s) [8] 0 0
2031 - Sydney
Recruitment postcode(s) [9] 0 0
2217 - Sydney
Recruitment postcode(s) [10] 0 0
2145 - Westmead
Recruitment postcode(s) [11] 0 0
4029 - Brisbane
Recruitment postcode(s) [12] 0 0
4102 - Brisbane
Recruitment postcode(s) [13] 0 0
4032 - Chermside
Recruitment postcode(s) [14] 0 0
- Southport
Recruitment postcode(s) [15] 0 0
5000 - Adelaide
Recruitment postcode(s) [16] 0 0
7000 - Hobart
Recruitment postcode(s) [17] 0 0
7250 - Launceston
Recruitment postcode(s) [18] 0 0
3128 - Box Hill
Recruitment postcode(s) [19] 0 0
3168 - Clayton
Recruitment postcode(s) [20] 0 0
3199 - Frankston
Recruitment postcode(s) [21] 0 0
- Geelong
Recruitment postcode(s) [22] 0 0
3084 - Heidelberg
Recruitment postcode(s) [23] 0 0
3004 - Melbourne
Recruitment postcode(s) [24] 0 0
3065 - Melbourne
Recruitment postcode(s) [25] 0 0
3050 - Parkville
Recruitment postcode(s) [26] 0 0
- Richmond
Recruitment postcode(s) [27] 0 0
6009 - Nedlands
Recruitment postcode(s) [28] 0 0
6150 - Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Extracorporeal Life Support Organization
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
National Heart Foundation, Australia
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
The Alfred
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Barwon Health
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Fiona Stanley Hospital
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
The Prince Charles Hospital
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Royal Prince Alfred Hospital, Sydney, Australia
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
St Vincent's Hospital, Sydney
Address [9] 0 0
Country [9] 0 0

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/show/NCT03793257
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Carol L Hodgson, PhD
Address 0 0
Australian and New Zealand Intensive Care Research Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Carol L Hodgson, PhD
Address 0 0
Country 0 0
Phone 0 0
+613 9903 0598
Fax 0 0
Email 0 0
carol.hodgson@monash.edu
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03793257