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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reducing brain injury in cardiac surgery
Scientific title
Dual vent circuit cardiopulmonary bypass to reduce ischemic brain injury in cardiac surgery.
Secondary ID [1] 287788 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elective cardiac valve repair or repair in the left heart and brain injury. 297 0
Cardiac valve disease 296673 0
Condition category
Condition code
Injuries and Accidents 334 334 0 0
Other injuries and accidents
Neurological 335 335 0 0
Surgery 336 336 0 0
Other surgery

Study type
Description of intervention(s) / exposure
Randomised controlled participant and assessor blinded study of an investigational dual vent circuit cardiopulmonary bypass technique in elective open heart surgery patients. Pre-operative and up to 6 weeks post-operative clinical assessments and magnetic resonance imaging studies performed.
Intervention code [1] 232 0
Comparator / control treatment
Conventional cardiopulmonary bypass in elective open heart surgery patients.
Control group

Primary outcome [1] 392 0
New ischemic lesions on post-operative magnetic resonance imaging studies.
Timepoint [1] 392 0
6 weeks
Secondary outcome [1] 860 0
Clinical outcome of death, coma, stroke, transient ischemic attack, post-operative encephalopathy and cognitive impairment.
Timepoint [1] 860 0
6 weeks

Key inclusion criteria
Able to give informed consent; neurologically independent; requiring elective cardiac valve replacement or repair in the left heart; able to undergo magnetic resonance imaging.
Minimum age
18 Years
Maximum age
Not stated
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Concomitant medical conditions making followup over 6 weeks unlikely; hemodynamically unstable; frequent cardiac arrhythmias; mobile atherosclerotic plaque in the aortic arch; overt congestive heart failure.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Opaque envelopes containing intervention allocation,
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random allocation in blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 2 / Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 144 0
New Zealand
State/province [1] 144 0

Funding & Sponsors
Funding source category [1] 394 0
Name [1] 394 0
Neurological Foundation of New Zealand
Address [1] 394 0
66 Grafton Rd, Grafton 1010
New Zealand
Country [1] 394 0
New Zealand
Funding source category [2] 395 0
Name [2] 395 0
National Heart Foundation of New Zealand
Address [2] 395 0
PO Box 17160. Greenlane
Auckland 1546
New Zealand
Country [2] 395 0
New Zealand
Primary sponsor type
Auckland City Hospital
Park Rd, Grafton
Auckland 1001
New Zealand
New Zealand
Secondary sponsor category [1] 323 0
Name [1] 323 0
Address [1] 323 0
Country [1] 323 0

Ethics approval
Ethics application status
Ethics committee name [1] 1384 0
Northern X Health and Disabilities Ethics Committee
Ethics committee address [1] 1384 0
Ethics committee country [1] 1384 0
New Zealand
Date submitted for ethics approval [1] 1384 0
Approval date [1] 1384 0
Ethics approval number [1] 1384 0

Brief summary
The primary purpose of the study is to investigate whether a newly developed cardiopulmonary (heart) bypass technique, reduces brain injury as a complication of the surgery, compared with conventional cardiopulmonary bypass techniques.
Trial website
Trial related presentations / publications
Barber PA, Hach S, Tippett LJ, Ross L, Merry AF, Milsom P. Cerebral ischemic lesions on diffusion-weighted imaging are associated with neurocognitive decline after cardiac surgery. Stroke. 2008;39(5):1427-33.

Barber PA, Tippett LJ, Merry AF, Hach S, Frampton C, Milsom P. Post-operative ischemia and cognitive impairment in cardiac surgery patients. Ann Thoracic Surgery. 2009;87(2):673-4.
Public notes

Principal investigator
Name 35926 0
Prof Peter Alan Barber
Address 35926 0
Department of Medicine
Grafton Campus
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 35926 0
New Zealand
Phone 35926 0
Fax 35926 0
Email 35926 0
Contact person for public queries
Name 9421 0
Prof Dr P Alan Barber
Address 9421 0
Department of Medicine
Grafton Campus
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 9421 0
New Zealand
Phone 9421 0
Fax 9421 0
Email 9421 0
Contact person for scientific queries
Name 349 0
Prof Dr P Alan Barber
Address 349 0
Department of Medicine
Grafton Campus
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 349 0
New Zealand
Phone 349 0
Fax 349 0
Email 349 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary