Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000214639
Ethics application status
Approved
Date submitted
23/08/2005
Date registered
25/08/2005
Date last updated
4/11/2015
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
ReBICS
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

Intervention/exposure
Study type
Interventional
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
Prevention
Comparator / control treatment
Conventional cardiopulmonary bypass in elective open heart surgery patients.
Control group
Active

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Prevention
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
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2005
Actual
4/07/2004
Date of last participant enrolment
Anticipated
Actual
21/01/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
144
Accrual to date
Final
97
Recruitment outside Australia
Country [1] 144 0
New Zealand
State/province [1] 144 0

Funding & Sponsors
Funding source category [1] 394 0
Charities/Societies/Foundations
Name [1] 394 0
Neurological Foundation of New Zealand
Country [1] 394 0
New Zealand
Funding source category [2] 395 0
Charities/Societies/Foundations
Name [2] 395 0
National Heart Foundation of New Zealand
Country [2] 395 0
New Zealand
Primary sponsor type
Hospital
Name
Auckland City Hospital
Address
Park Rd, Grafton
Auckland 1001
New Zealand
Country
New Zealand
Secondary sponsor category [1] 323 0
None
Name [1] 323 0
Nil
Address [1] 323 0
Country [1] 323 0

Ethics approval
Ethics application status
Approved
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
31/05/2004
Ethics approval number [1] 1384 0

Summary
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

Contacts
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
+6599236520
Fax 35926 0
Email 35926 0
[email protected]
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
+6499236520
Fax 9421 0
+6493677146
Email 9421 0
[email protected]
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
+6499236520
Fax 349 0
+6493677146
Email 349 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.