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Trial registered on ANZCTR


Registration number
ACTRN12615000543583
Ethics application status
Approved
Date submitted
12/05/2015
Date registered
28/05/2015
Date last updated
29/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Identification of biomarkers that correlate with clinical features and outcomes following concussion
Scientific title
Identification of biomarkers that correlate with clinical features and outcomes following concussion
Secondary ID [1] 286691 0
nil
Universal Trial Number (UTN)
U1111-1170-1199
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Concussion 295037 0
Condition category
Condition code
Injuries and Accidents 295295 295295 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
An observation of concussion for 28 days. Neuropsychological tests, biomarker levels and will be conducted on the day of presentation to the emergency department; MRI imaging will be conducted within the first week after injury where feasible. Neuropsychological tests and biomarker assays will be repeated at day 28; MRI will be repeated at day 28 if the first MRI was abnormal.
Intervention code [1] 291838 0
Not applicable
Comparator / control treatment
age matched controls not concussed
Control group
Active

Outcomes
Primary outcome [1] 295034 0
Biomarkers in plasma will be assessed using commercially available kits. Biomarkers to be assessed include markers of structural damage, oxidative stress and altered metabolism (e.g. glial acidic fibrillary protein, a II-spectrin N-terminal fragment (SNTF), myelin basic protein, S100b, malondialdehyde, 4-hydroxynonenal, 8-hydroxy deoxyguanosine, 3-nitrotyrosine, carboxymethyl lysine, pan and/ or phosphorylated tau).
Timepoint [1] 295034 0
Within 48 hours of injury
Primary outcome [2] 295035 0
Neuropsychological tests. The neuropsychological test battery is a composite outcome that will include measures assessing post-concussion symptoms, attention, learning, memory, executive functioning and effort. Specific tests will include the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Trail Making Test (TMT), Rey 15 Item memory test and the Rivermead Postconcussion Questionnaire. The Depression, Anxiety and Stress Scale (DASS-21) will also be administered.
Timepoint [2] 295035 0
Within 48 hours of injury
Primary outcome [3] 295036 0
traumatic brain lesions using MRI, particular diffusion tensor imaging for myelin structure
Timepoint [3] 295036 0
Within one week of injury
Secondary outcome [1] 314631 0
Biomarkers in plasma will be assessed using commercially available kits. Biomarkers to be assessed include markers of structural damage, oxidative stress and altered metabolism (e.g. glial acidic fibrillary protein, a II-spectrin N-terminal fragment (SNTF), myelin basic protein, S100b, malondialdehyde, 4-hydroxynonenal, 8-hydroxy deoxyguanosine, 3-nitrotyrosine, carboxymethyl lysine, pan and/ or phosphorylated tau).
Timepoint [1] 314631 0
28 days after injury
Secondary outcome [2] 314632 0
Neuropsychological tests. The neuropsychological test battery is a composite outcome and will include measures assessing post-concussion symptoms, attention, learning, memory, executive functioning and effort. Specific tests will include the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Trail Making Test (TMT), Rey 15 Item memory test and the Rivermead Postconcussion Questionnaire. The Depression, Anxiety and Stress Scale (DASS-21) will also be administered.
Timepoint [2] 314632 0
28 days after injury
Secondary outcome [3] 314633 0
traumatic brain lesions using MRI, particular diffusion tensor imaging for myelin structure
Timepoint [3] 314633 0
28 days after injury if 1st MRI abnormal

Eligibility
Key inclusion criteria
a. Patients between 14 and less than 50 years of age
b. Presenting to ED within 48 hours of head injury with symptoms that may be attributable to that injury
c. Cranial CT scan shows no intracranial injury, or CT was not performed

Age and sex matched control subjects will be recruited from healthy volunteers known to the researchers.
Minimum age
14 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Glasgow Coma Scale (GCS) 13 or less at time of initial assessment.
b. Ward of state, prisoner, under mental health treatment order.
c. Deemed unlikely to comply with 28 day follow up e.g. homeless.
d. Head injury deemed to be entirely due to primary seizure.
e. Clinically unstable from other injury or other significant non-TBI injury.
f. Non English speaking.
g. Known pre-existing cognitive impairment, such as an intellectual disability.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
As an exploratory study to determine the feasibility of our approach, only basic univariate analysis with exact logistic regression is appropriate, due to the sample size. This will assist with determining an indication of effect, ie whether there is an association between the initial biomarkers and the diagnosis of post-concussion syndrome. The biomarker results will be compared to the MRI results and the neurocognitive test results. Comparisons to the healthy controls at baseline will use non-parametric tests (Wilcoxon rank sum or Mann-Whitney U test). Random effects regression will be used to investigate change over time in outcomes measured at baseline and 28 days. Statistical analysis will be performed with Stata version 13 (StataCorp, College Station, Texas). Descriptive statistics and 95% confidence intervals will be reported.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2015
Actual
26/09/2015
Date of last participant enrolment
Anticipated
30/12/2017
Actual
30/12/2017
Date of last data collection
Anticipated
Actual
31/01/2018
Sample size
Target
80
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3784 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 9665 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 291262 0
University
Name [1] 291262 0
The University of Western Australia
Country [1] 291262 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
The University of Western Australia, 35 Stirling Hwy, Crawley WA 6009 Australia
Country
Australia
Secondary sponsor category [1] 289938 0
Hospital
Name [1] 289938 0
Royal Perth Hospital
Address [1] 289938 0
Box X2213 GPO, 6847
Perth WA
Country [1] 289938 0
Australia
Secondary sponsor category [2] 296659 0
University
Name [2] 296659 0
Curtin University
Address [2] 296659 0
Kent Street, Bentley, 6102, Western Australia
Country [2] 296659 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292824 0
WA Health
Ethics committee address [1] 292824 0
Ethics committee country [1] 292824 0
Australia
Date submitted for ethics approval [1] 292824 0
08/05/2015
Approval date [1] 292824 0
11/09/2015
Ethics approval number [1] 292824 0
REG 15-062

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

Contacts
Principal investigator
Name 57194 0
Prof Melinda Fitzgerald
Address 57194 0
c/- Experimental and Regenerative Neurosciences, School of Animal Biology, M317, The University of Western Australia (UWA), 35 Stirling Hwy, Crawley 6009 WA
Country 57194 0
Australia
Phone 57194 0
61 8 6488 2353
Fax 57194 0
Email 57194 0
lindy.fitzgerald@curtin.edu.au
Contact person for public queries
Name 57195 0
Melinda Fitzgerald
Address 57195 0
c/- Experimental and Regenerative Neurosciences, School of Animal Biology, M317, The University of Western Australia (UWA), 35 Stirling Hwy, Crawley 6009 WA
Country 57195 0
Australia
Phone 57195 0
61 8 6488 2353
Fax 57195 0
Email 57195 0
lindy.fitzgerald@curtin.edu.au
Contact person for scientific queries
Name 57196 0
Melinda Fitzgerald
Address 57196 0
c/- Experimental and Regenerative Neurosciences, School of Animal Biology, M317, The University of Western Australia (UWA), 35 Stirling Hwy, Crawley 6009 WA
Country 57196 0
Australia
Phone 57196 0
61 8 6488 2353
Fax 57196 0
Email 57196 0
lindy.fitzgerald@curtin.edu.au

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

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