Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000671460p
Ethics application status
Submitted, not yet approved
Date submitted
5/12/2024
Date registered
25/06/2025
Date last updated
25/06/2025
Date data sharing statement initially provided
25/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving Care for possible Traumatic Brain Injury using a Point-Of-Care blood test (ICare-TBI POC): A randomised controlled trial
Scientific title
Improving Care for possible Traumatic Brain Injury using a Point-Of-Care blood test (ICare-TBI POC): A randomised controlled trial to test the efficacy of using the i-STAT Point-Of-Care blood test measuring GFAP and UCHL1 to reduct the need for head Computer Tomography (CT) scans
Secondary ID [1] 313526 0
None
Universal Trial Number (UTN)
Trial acronym
ICare-TBI POC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury 335969 0
Condition category
Condition code
Emergency medicine 332555 332555 0 0
Other emergency care
Neurological 333153 333153 0 0
Other neurological disorders
Injuries and Accidents 333154 333154 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a next day head CT scan.

Patients will have 5mL of blood drawn. This will be tested on the Abbott i-Stat TBI device. .
The Abbott i-Stat TBI Whole blood has two biomarker assays for two molecules, GFAP and UCHL1, with FDA approved thresholds. For the test to be negative both GFAP and UCHL1 concentrations must be below these pre-defined thresholds, otherwise the test is positive.
If the test is negative then patients will be randomised to usual care involving a CT head scan during the current ED visit or to having the CT head scan the next day. If the test is positive the patients will receive usual care (same day CT head scan during the current ED visit). The intervention period ends after leaving the ED (if usual care) or after the CT head scan if it is done the next day.
Intervention code [1] 330100 0
Early detection / Screening
Comparator / control treatment
Patients with a negative result on the Abbott i-Stat TBI who are randomised to usual care. Usual care is same day CT during the current ED visit.
Control group
Active

Outcomes
Primary outcome [1] 340071 0
Need for CT head
Timepoint [1] 340071 0
At the conclusion of study
Secondary outcome [1] 442550 0
Length of ED stay
Timepoint [1] 442550 0
Following discharge from ED
Secondary outcome [2] 442552 0
Referral to concussion clinic
Timepoint [2] 442552 0
At the conclusion of study
Secondary outcome [3] 442553 0
Representations
Timepoint [3] 442553 0
30 days and 1 year post index ED presentation
Secondary outcome [4] 442554 0
Death
Timepoint [4] 442554 0
30 days and 1 year post index ED presentation
Secondary outcome [5] 442555 0
Safety: Presence of acute traumatic intracranial lesions
Timepoint [5] 442555 0
Following CT review
Secondary outcome [6] 442556 0
Safety: Neuropathology - any of: • Subdural • Extradural • Intracerebral haematoma • Diffuse axonal injury • Skull fracture This will be assessed as a composite outcome
Timepoint [6] 442556 0
Following CT review

Eligibility
Key inclusion criteria
• Adults >=18 years of age.
• Presenting within 24 hours of suspected mild or moderate TBI.
• Attending physician’s initial judgment is the need for a head CT.
• GCS on arrival in the ED 13-15
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients presenting >24 hours of suspected injury or with an unknown time of onset predicted to be >24 hours
• GCS <13
• Pre-existing brain injury at time of presentation, such as recent TBI or recent stroke
• Pre-existing neurological condition such as dementia, acute psychosis, motor neurone disease, multiple-sclerosis, learning difficulties
• Unable for them or their guardian to give verbal consent
• Next day head CT scan not possible for other reasons
• Unable to return next day
• (eg lives out of town).
• Clinician perceived need to do an immediate CT irrespective of biomarker results because of red flags.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will not be concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created
by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The primary comparison will be between the two randomised arms.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2026
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 26771 0
New Zealand
State/province [1] 26771 0

Funding & Sponsors
Funding source category [1] 317980 0
Commercial sector/Industry
Name [1] 317980 0
Abbott Point of Care
Country [1] 317980 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
Emergency Care Foundation
Address
Country
New Zealand
Secondary sponsor category [1] 320321 0
Hospital
Name [1] 320321 0
Christchurch Hospital
Address [1] 320321 0
Country [1] 320321 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316650 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 316650 0
Ethics committee country [1] 316650 0
New Zealand
Date submitted for ethics approval [1] 316650 0
14/11/2024
Approval date [1] 316650 0
Ethics approval number [1] 316650 0

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

Contacts
Principal investigator
Name 138534 0
Prof Martin Than
Address 138534 0
Canterbury District Health Board and Emergency Care Foundation 21 Taylors Mistake Road Sumner Christchurch 8081
Country 138534 0
New Zealand
Phone 138534 0
+64 3 326 7599
Fax 138534 0
Email 138534 0
[email protected]
Contact person for public queries
Name 138535 0
Martin Than
Address 138535 0
Canterbury District Health Board and Emergency Care Foundation 21 Taylors Mistake Road Sumner Christchurch 8081
Country 138535 0
New Zealand
Phone 138535 0
+64 3 326 7599
Fax 138535 0
Email 138535 0
[email protected]
Contact person for scientific queries
Name 138536 0
Professor John Pickering
Address 138536 0
c/- Emergency Care Foundation P O Box 13-149 Christchurch 8140
Country 138536 0
New Zealand
Phone 138536 0
+64 21 2537877
Fax 138536 0
Email 138536 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Not for public consumption. These patients are all undergoing clinical assessment and it is not appropriate to make their details public even after de-identification because it may be possible to re-identify the patients.




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.