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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
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Trial registered on ANZCTR
Registration number
ACTRN12625000670471
Ethics application status
Approved
Date submitted
12/02/2025
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) : Verification of the Abbott i-STAT TBI test
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Scientific title
Improving Care for possible Traumatic Brain Injury by verification of the precision of the i-STAT TBI Point-Of-Care blood test for the biomarkers Neuronal ubiquitin C-terminal hydrolase-L1 (UCH-L1) and glial fibrillary acidic protein (GFAP).
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Secondary ID [1]
313948
0
Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury
336655
0
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Condition category
Condition code
Emergency medicine
333150
333150
0
0
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Other emergency care
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Neurological
333151
333151
0
0
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Other neurological disorders
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Injuries and Accidents
333152
333152
0
0
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Other injuries and accidents
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
During an emergency department (ED) visit patients identified as having mild Traumatic Brain Injury (mTBI) and whom the attending physician has ordered a computerised tomography (CT) head scan will be consented to allow data collection and a single blood draw. They will then have blood drawn. The i-STAT TBI POC test will measure the concentrations of two biomarkers, UCH-L1 and GFAP. The test will not be used in clinical practice, the results will not be known to attending physicians. Participation ends after discharge from ED.
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Intervention code [1]
330540
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
340721
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Precision of measurements for glial fibrillary acidic protein (GFAP)
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Assessment method [1]
340721
0
Repeat measurements with the i-STAT device on the same blood draw. The Coefficient of variation (CV) will be calculated as the standard deviation divided my mean of the measurements.
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Timepoint [1]
340721
0
Following collection of all blood samples.
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Primary outcome [2]
340722
0
Proportion of patients with biomarker concentrations above the manufacturer recommended thresholds
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Assessment method [2]
340722
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The number of patients with at least one of GFAP or UCH-L1 above the manufacturer's recommended threshold divided by the total number of patients.
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Timepoint [2]
340722
0
Following collection of all blood samples.
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Primary outcome [3]
341738
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Precision of measurements for ubiquitin C-terminal hydrolase-L1 (UCH-L1)
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Assessment method [3]
341738
0
Repeat measurements with the i-STAT device on the same blood draw. The Coefficient of variation (CV) will be calculated as the standard deviation divided my mean of the measurements.
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Timepoint [3]
341738
0
Following collection of all blood samples.
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Secondary outcome [1]
444858
0
Haemolysis interference
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Assessment method [1]
444858
0
A plasma sample will be spiked to increase their haemolysis index. Repeat measurements of the two biomarkers will be made and compared to the un-spiked measurements
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Timepoint [1]
444858
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Following ED blood draw
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Secondary outcome [2]
444859
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Rates of any finding on the CT scan
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Assessment method [2]
444859
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CT head reports will be read
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Timepoint [2]
444859
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Following a CT head on the day of ED presentation
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Secondary outcome [3]
444860
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Rates of representation to the ED with symptoms relating to the mTBI
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Assessment method [3]
444860
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The number of patients who represent to the ED divided by the total number of patients recruited. Data will be retrieved from the health records.
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Timepoint [3]
444860
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30 days post ED presentation
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Secondary outcome [4]
444861
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Rate of death (all cause)
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Assessment method [4]
444861
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Number who died divided by the total number of patients recruited. Data will be retrieved from the health records.
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Timepoint [4]
444861
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30 days post ED presentation
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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.
• Glasgow Coma Score (GCS) on arrival in the ED 13-15
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
• Clinician perceived need to do an immediate CT irrespective of biomarker results because of red flags.
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/07/2025
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Actual
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Date of last participant enrolment
Anticipated
31/01/2026
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Actual
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Date of last data collection
Anticipated
31/03/2026
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Actual
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Sample size
Target
220
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
26884
0
New Zealand
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State/province [1]
26884
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Canterbury
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Funding & Sponsors
Funding source category [1]
318442
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Commercial sector/Industry
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Name [1]
318442
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Abbott Point of Care
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Address [1]
318442
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Country [1]
318442
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United States of America
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Primary sponsor type
Charities/Societies/Foundations
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Name
Emergency Care Foundation
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Address
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Country
New Zealand
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Secondary sponsor category [1]
320838
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Hospital
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Name [1]
320838
0
Christchurch Hospital
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Address [1]
320838
0
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Country [1]
320838
0
New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317060
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Southern Health and Disability Ethics Committee
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Ethics committee address [1]
317060
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https://ethics.health.govt.nz/about/southern-health-and-disability-ethics-committee/
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Ethics committee country [1]
317060
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New Zealand
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Date submitted for ethics approval [1]
317060
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14/11/2024
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Approval date [1]
317060
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02/05/2025
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Ethics approval number [1]
317060
0
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Summary
Brief summary
When someone has a knock to the head they may induce a mild traumatic brain injury (TBI). Emergency department (ED) doctors assess if this is likely and may order a head CT scan to look for any damage. Most of these scans are negative (no damage). However, there use means extended stays in the ED for patients and this contributes to overcrowding. Recently the FDA approved a blood test that can determine that some people are at very low risk of having damage seen on a CT. In theory, this could mean less scans and shorter ED stays for many people. We are testing this device by checking that the numbers produced can be consistently produced without error and that in the New Zealand ED population it accurately predict a good proportion of patients as being low-risk for damage on a CT.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
139866
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Prof Martin Than
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Address
139866
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Canterbury District Health Board and Emergency Care Foundation 21 Taylors Mistake Road Sumner Christchurch 8081
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Country
139866
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New Zealand
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Phone
139866
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+64 3 326 7599
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Fax
139866
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Email
139866
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[email protected]
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Contact person for public queries
Name
139867
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Martin Than
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Address
139867
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Canterbury District Health Board and Emergency Care Foundation 21 Taylors Mistake Road Sumner Christchurch 8081
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Country
139867
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New Zealand
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Phone
139867
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+64 3 326 7599
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Fax
139867
0
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Email
139867
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[email protected]
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Contact person for scientific queries
Name
139868
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Professor John Pickering
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Address
139868
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c/- Emergency Care Foundation P O Box 13-149 Christchurch 8140
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Country
139868
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New Zealand
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Phone
139868
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+64 21 2537877
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Fax
139868
0
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Email
139868
0
[email protected]
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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.
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