Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000388617
Ethics application status
Approved
Date submitted
2/09/2005
Date registered
14/09/2005
Date last updated
14/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study of CABG outcomes on and off-pump (SCOOP)
Scientific title
Randomised study of the effects on neurocognitive function, clinical outcomes and hospital costs of CABG surgery with cardiopulmonary bypass versus CABG without cardiopulmonary bypass in patients with coronary artery disease.
Universal Trial Number (UTN)
Trial acronym
SCOOP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 492 0
Condition category
Condition code
Cardiovascular 572 572 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CABG surgery - eligible patients randomlised to on-CPB pump
Intervention code [1] 343 0
None
Comparator / control treatment
Off-pump
Control group
Active

Outcomes
Primary outcome [1] 657 0
Neurocognitive function measured with standard tests
Timepoint [1] 657 0
At 1, 3 and 12 months post CABG surgery
Secondary outcome [1] 1357 0
Surgical outcomes and complications.
Timepoint [1] 1357 0

Eligibility
Key inclusion criteria
Patients for elective CABG. Coronary anatomy suitable for either on- or off-pump surgery. Not single LAD or left main disease. No previous disabling stroke or other condition affecting ability to complete tests of cognitive function.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation to the randomly assigned treatment groups (as described below) was provided by a central telephone randomisation service. The patient was randomised the day prior to surgery to enable set-up of the operating room. The patient and family remained blinded to treatment assignment as did the psychologist performing the follow-up assessments. Patients were reminded before each assessment that, even if they knew, the psychologist was to remian blinded to the surgical technique throughout the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The online program at http://www.randomization.com was used to randomly assign patient to two parallel treatment groups in permuted block randomisation with variable block sizes. The block sequence was varied randomly. Study staff was blind to the block size and sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
9/01/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 622 0
Charities/Societies/Foundations
Name [1] 622 0
SCGH Foundation for Advanced Medical Research
Country [1] 622 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Sir Charles Gairdner Foundation for Advanced Medical Research provided competitive funding.
Address
Country
Australia
Secondary sponsor category [1] 507 0
None
Name [1] 507 0
NA
Address [1] 507 0
Country [1] 507 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35608 0
Address 35608 0
Country 35608 0
Phone 35608 0
Fax 35608 0
Email 35608 0
Contact person for public queries
Name 9532 0
Mr Mark Newman
Address 9532 0
Department of Cardiothoracic Surgery
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA 6009
Country 9532 0
Australia
Phone 9532 0
+61 8 93462677
Fax 9532 0
Email 9532 0
[email protected]
Contact person for scientific queries
Name 460 0
Pamela Bradshaw
Address 460 0
School of Population Health
University of Western Australia
M431
Stirling Highway
Ceawley WA 6009
Country 460 0
Australia
Phone 460 0
+61 8 64881285
Fax 460 0
Email 460 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.