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Trial registered on ANZCTR


Registration number
ACTRN12620000254998
Ethics application status
Approved
Date submitted
13/02/2020
Date registered
26/02/2020
Date last updated
2/03/2020
Date data sharing statement initially provided
26/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining associations between proteins in the blood and cognitive function among patients undergoing cardiac and non-cardiac surgery (BRAIN-S)
Scientific title
Using biomarkers of neurological injury to predict cognitive function after cardiac and non-cardiac anaesthesia and surgery (BRAIN-S)
Secondary ID [1] 300537 0
None
Universal Trial Number (UTN)
Trial acronym
BRAIN-S
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium 316248 0
Postoperative Cognitive Dysfunction 316249 0
Condition category
Condition code
Anaesthesiology 314535 314535 0 0
Anaesthetics
Neurological 314536 314536 0 0
Dementias
Surgery 314537 314537 0 0
Other surgery
Mental Health 314616 314616 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients undergoing major elective cardiac and non-cardiac surgery will be recruited for this study. We will quantitate the change in two blood biomarkers of neurological damage (neurofilament light and tau) after cardiac compared to non-cardiac surgery. We will also examine these biomarkers to the subsequent neurocognitive outcomes in the postoperative period. All anaesthesia and surgery will be undertaken according to normal clinical practice. Participants will be followed over 3 months.
Intervention code [1] 316841 0
Early Detection / Screening
Comparator / control treatment
This study will not involve the recruitment of control participants.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322858 0
Fluctuating levels of neurofilament light.
Timepoint [1] 322858 0
Blood samples will be taken prior to anaesthetic induction as a baseline measurement and again at 6 and 24 hours following surgery. Where possible a discharge and a 6-week blood sample will also be taken.
Primary outcome [2] 322859 0
Fluctuating levels of tau proteins.
Timepoint [2] 322859 0
Blood samples will be taken prior to anaesthetic induction as a baseline measurement and again at 6 and 24 hours following surgery. Where possible a discharge and a 6-week blood sample will also be taken.
Primary outcome [3] 322860 0
Incidence of postoperative cognitive dysfunction as measured by a neuropsychological test battery. The components of the battery are as follows: memory (CERAD word learning test - immediate and delayed recall); attention (Trail Making A); executive function (Trail Making B, Digit Symbol Substitution Test, Clock Drawing Test); semantic fluency (controlled oral word association); verbal fluency (FAS); and motor function (Grooved Pegboard - dominant and non-dominant). We will also administer the Montreal Cognitive Assessment as part of the neuropsychological test battery (composite primary outcome).
Timepoint [3] 322860 0
7 days and 3 months postoperatively.
Secondary outcome [1] 380036 0
Postoperative delirium.
Timepoint [1] 380036 0
Postoperative delirium will be assessed once daily up to 5 days following surgery or until discharge. Delirium assessments will be conducted by trained research staff using the 3 minute Diagnostic Confusion Assessment Method (3D-CAM).

Eligibility
Key inclusion criteria
1. Greater than or equal to 65 years of age
2. Scheduled for elective cardiac or non-cardiac surgery (excluding valvular surgery, to avoid confounding factors of solid and air emboli)
3. Elective non-cardiac surgery procedures anticipated to last greater than one hour
4. Have no contraindication to neuropsychological testing (e.g. language, visual or hearing impairment)
5. Reside in an accessible proximity to the hospital for neuropsychological testing
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pre-existing neurological or clinically evident neurovascular disease (e.g. stroke)
2. Dementia of any aetiology
3. Undergone general anaesthetic in past 6 months
4. Associated medical problems that may lead to significant complications and loss to follow-up

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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] 15950 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 29434 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 304951 0
Other Collaborative groups
Name [1] 304951 0
Australia and New Zealand College of Anaethetists
Address [1] 304951 0
ANZCA House,
630 St Kilda Road,
Melbourne, Victoria 3004,
Australia
Country [1] 304951 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
PO Box 2900
Fitzroy
VIC 3065
Country
Australia
Secondary sponsor category [1] 305308 0
None
Name [1] 305308 0
Address [1] 305308 0
Country [1] 305308 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305360 0
St Vincent's Hospital HREC
Ethics committee address [1] 305360 0
PO Box 2900
Fitzroy
VIC 3065
Ethics committee country [1] 305360 0
Australia
Date submitted for ethics approval [1] 305360 0
10/01/2020
Approval date [1] 305360 0
17/02/2020
Ethics approval number [1] 305360 0

Summary
Brief summary
Recent preliminary findings suggest markers of neuronal damage (neurofilament light and tau) are associated with general anesthesia and surgery, which in turn may be associated with the clinical outcomes of delirium and postoperative cognitive dysfunction. Specifically, in a pilot study we observed that people undergoing cardiac surgery showed greater increases in plasma neurofilament light and tau than those undergoing non-cardiac surgery.

The aim of this investigation is to compare the plasma levels of NFL and tau after cardiac compared to non-cardiac surgery and relate these levels to the subsequent neurocognitive outcomes in the postoperative period. Cognitive and memory testing will take place prior to surgery, at 7 days after surgery and at 3 months after surgery. Tests for delirium and collection of blood samples will also be conducted during the participants' time in hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100114 0
A/Prof Brendan Silbert
Address 100114 0
St Vincent's Hospital
PO Box 2900
Fitzroy
VIC 3065
Country 100114 0
Australia
Phone 100114 0
+61 0400 232 611
Fax 100114 0
Email 100114 0
brendan.silbert@svha.org.au
Contact person for public queries
Name 100115 0
Ms Kelly Atkins
Address 100115 0
St Vincent's Hospital
PO Box 2900
Fitzroy
VIC 3065
Country 100115 0
Australia
Phone 100115 0
+61 03 9288 2072
Fax 100115 0
Email 100115 0
kelly.atkins@svha.org.au
Contact person for scientific queries
Name 100116 0
Ms Kelly Atkins
Address 100116 0
St Vincent's Hospital
PO Box 2900
Fitzroy
VIC 3065
Country 100116 0
Australia
Phone 100116 0
+61 03 9231 2251
Fax 100116 0
Email 100116 0
kelly.atkins@svha.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It is intended that the IPD will be made available for this trial but specific details have not yet been ascertained.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Clinical study report
Ethical approval
Analytic code
How or where can supporting documents be obtained?
Type [1] 6894 0
Study protocol
Citation [1] 6894 0
Link [1] 6894 0
Email [1] 6894 0
kelly.atkins@svha.org.au
Other [1] 6894 0
Attachment [1] 6894 0
Type [2] 6895 0
Statistical analysis plan
Citation [2] 6895 0
Link [2] 6895 0
Email [2] 6895 0
kelly.atkins@svha.org.au
Other [2] 6895 0
Attachment [2] 6895 0
Type [3] 6896 0
Informed consent form
Citation [3] 6896 0
Link [3] 6896 0
Email [3] 6896 0
kelly.atkins@svha.org.au
Other [3] 6896 0
Attachment [3] 6896 0
Type [4] 6897 0
Clinical study report
Citation [4] 6897 0
Link [4] 6897 0
Email [4] 6897 0
kelly.atkins@svha.org.au
Other [4] 6897 0
Attachment [4] 6897 0
Type [5] 6898 0
Ethical approval
Citation [5] 6898 0
Link [5] 6898 0
Email [5] 6898 0
kelly.atkins@svha.org.au
Other [5] 6898 0
Attachment [5] 6898 0
Type [6] 6899 0
Analytic code
Citation [6] 6899 0
Link [6] 6899 0
Email [6] 6899 0
kelly.atkins@svha.org.au
Other [6] 6899 0
Attachment [6] 6899 0
Summary results
No Results