None listed
Conditions
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 with a trial in which some low-risk patients will not have the CT scan on the same day, but the next day. This will tell us if we can do away with CT scans for the low-risk patients entirely.
Interventions
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
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.
Sponsors
Emergency Care Foundation
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
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. • 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 • 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.
Outcome results
None listed