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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
16/01/2019

Titles & IDs
Public title
The EXCEL Study: A Comprehensive Bi- National Registry on the Treatment and Outcomes of Patients Requiring ECMO
Scientific title
The EXCEL Study: A Comprehensive Bi- National 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
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
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 six 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
Number patients who survive to six months following ECMO initiation - Measured using a trained, blinded assessor via telephone interview
Timepoint [2] 0 0
At 6 months from study enrolment
Secondary outcome [3] 0 0
Number of patients with disability at six months - WHODAS 2.0 measured using a trained, blinded assessor via telephone interview
Timepoint [3] 0 0
At 6 months from study enrolment
Secondary outcome [4] 0 0
Healthcare utilization -caseload per centre - ECMO patient numbers (caseload per centre)
Timepoint [4] 0 0
Up to 12 months from study enrolment
Secondary outcome [5] 0 0
Healthcare utilization - ECMO initiation timing - Timing of ECMO initiation by staff including an ECMO retrieval team
Timepoint [5] 0 0
Up to 12 months from study enrolment
Secondary outcome [6] 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 [6] 0 0
Up to 12 months from study enrolment
Secondary outcome [7] 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 [7] 0 0
Up to 12 months from study enrolment
Secondary outcome [8] 0 0
Health-related quality of life at six months using the EQ5D-5L - EQ5D-5L measured using 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 [8] 0 0
At 6 months from study enrolment
Secondary outcome [9] 0 0
Psychological function at six months - Measured using a trained, blinded assessor via telephone interview
Timepoint [9] 0 0
At 6 months from study enrolment
Secondary outcome [10] 0 0
Return to work at six months - Measured using a trained, blinded assessor via telephone interview
Timepoint [10] 0 0
At 6 months from study enrolment
Secondary outcome [11] 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 [11] 0 0
Measured from ECMO commencement to hospital discharge until 6 months following hopsital admission.

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

- Patients aged 18 years or older
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- There is no exclusion criteria for The EXCEL Study

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet 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)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
ICU patients with severe heart or lung failure may require an external device called
extra-corporeal membrane oxygenation (ECMO) to oxygenate their blood. The use of ECMO is
rapidly increasing. It has the capability to completely replace a non-functioning heart or
lungs for days to weeks, but ECMO patients only have a 42% hospital survival rate. ECMO use
is associated with significant costs and risks, and it needs experienced staff. To better
manage this complex intervention, the investigators need to have quality data on patients who
require ECMO.

The aim of EXCEL is to create a bi-national network of integrated care that will identify
best practice and cost effectiveness for patients suffering from acute cardiac failure, lung
failure, or cardiac arrest and require ECMO. The investigators will collect information on
525 ECMO patients while in the ICU and the investigators aim to utilise telephone follow-up
of survivors to assess disability free survival, quality of life and other long term outcomes
at 6 and 12 months. Information collected will be stored in the EXCEL database and will be
periodically reviewed to address safety concerns, clinical questions and process of care
issues. Data will be collected over a 3 year period.
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