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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

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).

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625000670471
Enrollment
220
Registered
2025-06-25
Start date
2025-07-01
Completion date
2026-01-31
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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. Particip

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.

Sponsors

Emergency Care Foundation
Lead SponsorCharities/Societies/Foundations

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026