Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000259640
Ethics application status
Approved
Date submitted
8/02/2023
Date registered
10/03/2023
Date last updated
21/05/2024
Date data sharing statement initially provided
10/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
An observational study exploring outcomes following concussion to optimise recovery
Scientific title
A prospective cohort study to predict poor outcomes following mild traumatic brain injury
Secondary ID [1] 308858 0
Nil known
Universal Trial Number (UTN)
U1111-1287-6061
Trial acronym
CREST-II
Linked study record
UTN: U1111-1236-41420, ACTRN12619001226190
ACTRN12619001226190 is the parent study of the current trial.. The current study is continuing with a revised protocol that has a slightly different recruitment criteria and assesses different outcome measures,

Health condition
Health condition(s) or problem(s) studied:
Concussion 328826 0
Persistent post-concussion symptoms 328827 0
Mild traumatic brain injury 328830 0
Condition category
Condition code
Neurological 325830 325830 0 0
Other neurological disorders
Injuries and Accidents 326007 326007 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
People who have experienced a mild traumatic brain injury (mTBI) are recruited within 12 hours of their injury. At the time of recruitment, participants will complete a questionnaire about their mTBI in-person with an experienced researcher. Questions will cover the nature of the injury, as well as the person's symptoms, relevant comorbidities, medical history, and general health and lifestyle factors. A blood and saliva sample will also be taken at the time of recruitment, less than 12 hours following injury.

Within 4 days of their injury, participants will attend further in-person testing that will include vestibular and balance assessments, further symptomology assessment, computer-based cognitive testing and undergo an MRI scan. The in-person testing will take approximately 3 hours.

All participants are followed up by phone at 2 weeks, 1-, 3-, 6- and 12-months following their injury. The follow-up questionnaire is based around self-assessment of symptoms and takes around 10 minutes. The total duration of participation is 1 year post-injury.
Intervention code [1] 325303 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333675 0
Existence of Persistent Post-concussive Symptoms (PPCS) as determined by overall score on the Rivermead Post-Consussion Questionnaire (RPQ)
Timepoint [1] 333675 0
2 weeks, 1 month, 3 months, 6 months and 12 months following mTBI
Secondary outcome [1] 417899 0
Cognitive function assessed using the Cogstate brief battery (computeristed tests) assessing attention, working memory, psychomotor function and visual learning.
Timepoint [1] 417899 0
Within 4 days of injury
Secondary outcome [2] 417906 0
Exploratory outcome: MRI abnormality
Timepoint [2] 417906 0
Within 4 days of injury
Secondary outcome [3] 417907 0
Quality of life measured with the Quality of Life after Brain Injury - overall scale (QOLIBRI-OS)
Timepoint [3] 417907 0
2 weeks, 1-, 3-, 6- and 12- months following injury
Secondary outcome [4] 417910 0
Exploratory outcome: Abnormal biomarkers in blood and saliva samples
Timepoint [4] 417910 0
Within 12 hours of injury
Secondary outcome [5] 417911 0
Vestibular-ocular function assessed with the Vestibular-Oculomotor Screening tool (VOMS)
Timepoint [5] 417911 0
Within 4 days of injury
Secondary outcome [6] 417912 0
Total score for balance assessed with the Balance Error Scoring System (BESS)
Timepoint [6] 417912 0
Within 4 days of injury

Eligibility
Key inclusion criteria
i) Clinical diagnosis of concussion made by a medical practitioner
ii) Aged 14 – 65 years
iii) Able to be enrolled within 12 hours of head injury with symptoms attributable to that injury
iv) Post-Traumatic Amnesia of less than 24 hours
v) No significant findings on acute brain CT scan, or CT scan not required
vi) Willing and able to attend additional in-person assessment within 4 days of injury
Minimum age
14 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) Glasgow Coma Scale <14 at the time of initial assessment
ii) Significant history of pre-existing conditions that would interfere with outcome assessment and follow-up (eg. Substance abuse/alcohol abuse, homelessness, terminal illness)
iii) Significant debilitating pre-existing diagnosed mental health disorder that would interfere with neuropsychological and possibly blood or saliva biomarker outcome measures or follow up (eg schizophrenia, bipolar disorder)
iv) Significant pre-existing neurological condition which may interfere with ability to complete outcome measures or follow up (eg. Stroke, dementia)
v) Pre-existing cognitive impairment such as intellectual disability which may interfere with ability to undertake neuropsychological examination
vi) Non-English speakers or poor English language skills which may interfere with ability to undertake neuropsychological examination
vii) Pregnant women
viii) Prisoners in custody or people known to be involved in illegal activity
ix) Deemed unlikely to comply with scheduled follow ups (e.g. homeless, alcohol dependence).
x) Head injury deemed to be entirely due to primary seizure.
xi) Significant other physical trauma that would interfere with physical and/or biochemical outcome assessments and follow up (eg lower limb injuries that would impede balance assessment, neck injuries that would restrict head movements, or cause changes in blood or saliva biomarkers)
xii) Epilepsy or history of seizures
xiii) Meets exclusion criteria to undertake MRI, which can be any of the following:
• Has cardiac pacemaker or pacing wire in situ
• Has metal surgical clips or staples of any kind (particularly aneurysm clips) in situ
• Has had lap band surgery
• Has electronic inner ear implants (bionic ears)
• Has metal fragments in your eyes (past or present)
• Has electronic stimulators
• Has implanted pumps
• Has metal pins or rods in bones
• Has an IUCD (intrauterine contraceptive device) fitted
• Has shrapnel, bullets or foreign bodies


Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Baseline characteristics will be compared between men and women using Chi-square tests for categorical variables and t-tests for continuous variables. The analyses will be repeated by age, outcome (PPCS or no PPCS), nature of injury (single event or sequelae), and symptoms at presentation.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/06/2023
Actual
20/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
QLD,WA,VIC
Recruitment hospital [1] 23890 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 23891 0
The Alfred - Melbourne
Recruitment hospital [3] 23892 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 39372 0
3004 - Melbourne
Recruitment postcode(s) [2] 39373 0
4029 - Herston
Recruitment postcode(s) [3] 39371 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 313079 0
University
Name [1] 313079 0
Curtin University
Country [1] 313079 0
Australia
Funding source category [2] 313083 0
Charities/Societies/Foundations
Name [2] 313083 0
Perron Institute for Neurological Research and Translation
Country [2] 313083 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
The Curtin Health Innovation and Research Institute (CHIRI)
Building 305 Curtin University
Kent St, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 314867 0
None
Name [1] 314867 0
Address [1] 314867 0
Country [1] 314867 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312325 0
Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 312325 0
55 Commercial Rd Prahran VIC 3004
Ethics committee country [1] 312325 0
Australia
Date submitted for ethics approval [1] 312325 0
05/01/2023
Approval date [1] 312325 0
21/06/2023
Ethics approval number [1] 312325 0
267/23

Summary
Brief summary
This observational study will investigate injury characteristics and clinical assessments to measure post-concussion symptoms at different time points in the first year post injury and use this information to predict people who are more likely to have a poor outcome after concussion.

Participants will be recruited via hospital emergency departments following initial medical practitioner assessment and concussion diagnosis. Once consented into the study, participants will complete a questionnaire about their concussion injury and medical history, in addition to having a blood and saliva sample taken. Other clinical assessments and an MRI scan will also be completed within 4 days of their injury. At 2 weeks, 1-, 3-, 6- and 12- months following injury, participants will be contacted via telephone to complete a follow up questionnaire about their concussion symptoms and quality of life post injury.

Having a better understanding of people who are at risk of developing persistent symptoms following a concussion will enable more targeted and timely clinical care to minimise distress and disability that may be experienced as a result of injury.
Trial website
https://www.connectivity.org.au/connecting-to-current-research-projects/aus-mtbi-participant-information/
Trial related presentations / publications
nil
Public notes
Additional ethics reciprocal approvals will be submitted to:
1) Curtin University HREC
2) University of Western Australia HREC
3) Metro North HREC A - The Royal Brisbane and Women's Hospital
4) Royal Perth Hospital HREC

Contacts
Principal investigator
Name 124258 0
Prof Lindy Fitzgerald
Address 124258 0
Curtin University
Level 3, Sarich Neuroscience Institute
8 Verdun st, Nedlands WA 6009
Country 124258 0
Australia
Phone 124258 0
+61 08 64570514
Fax 124258 0
Email 124258 0
lindy.fitzgerald@curtin.edu.au
Contact person for public queries
Name 124259 0
Prof Lindy Fitzgerald
Address 124259 0
Curtin University
Level 3, Sarich Neuroscience Institute
8 Verdun st, Nedlands WA 6009
Country 124259 0
Australia
Phone 124259 0
+61 08 64570514
Fax 124259 0
Email 124259 0
lindy.fitzgerald@curtin.edu.au
Contact person for scientific queries
Name 124260 0
Prof Lindy Fitzgerald
Address 124260 0
Curtin University
Level 3, Sarich Neuroscience Institute
8 Verdun st, Nedlands WA 6009
Country 124260 0
Australia
Phone 124260 0
+61 08 64570514
Fax 124260 0
Email 124260 0
lindy.fitzgerald@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Aggregated data will be shared upon request 12 months after the conclusion of the study.
When will data be available (start and end dates)?
Aggregated data will be shared upon request 12 months after the conclusion of the study, with no end date.
Available to whom?
Case-by-case basis at the discretion of Principal Investigator
Available for what types of analyses?
No analysis specified.
How or where can data be obtained?
Access subject to approvals by Principal Investigator, Melinda Fitzgerald (lindy.fitzgerald@curtin.edu.au)


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.