Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000961347
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
7/07/2026
Date registered
Help: Date registered
5/08/2026
Date last updated
Help: Date last updated
5/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
5/08/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective randomised controlled trial of an AI-supported model of care for non-contrast Computed Tomography (CT) Brain interpretation in the Emergency Department
Scientific title
Research in AI Systems in Emergency Department – Computed Tomography Brain (RAISED-CTB) Stage Two: A prospective randomised controlled trial of an AI-supported model of care for non-contrast CT Brain interpretation in the Emergency Department
Additional trial identifiers [1] 317671 0
Nil
Universal Trial Number (UTN)
Trial acronym
RAISED-CTB
Related trial records

Health condition
Health condition(s) studied:
Minor head injury 342482 0
Headache requiring Computed Tomography (CT) brain imaging 342874 0
Condition category
Condition code
Emergency medicine 338610 338610 0 0
Other emergency care
Injuries and Accidents 338989 338989 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Patients will be triaged into the emergency department as per standard practice. Patients will be screened by the treating clinician or researcher for eligibility.
Eligible patients who provide informed consent will be randomised in a 1:1 ratio.
- Intervention Group (AI-Supported Care Model): Following scan acquisition, the images will be processed by the AI tool. A senior emergency department clinician will review the images with the assistance of the AI output, which provides a binary classification of 'remarkable' or 'unremarkable'.
- If there is a consensus between the senior clinician and the AI that the scan is unremarkable, the patient can be considered for expedited discharge.
- Discharged patients will be referred to the Royal Prince Alfred Virtual Hospital for a follow-up call from a physician within 24 hours, by which time the formal radiologist report will be available to confirm the unremarkable finding.
- If the AI tool indicates a 'remarkable' scan, or if the clinician identifies a remarkable finding regardless of the AI output, the patient will follow the standard care pathway and remain in the emergency department to await the formal report.
- If an AI deemed ‘unremarkable’ scan is later found to be remarkable by a radiologist this will be communicated to an emergency department doctor and the patient contacted and asked to return for in person assessment if necessary (as per standard practice for missed diagnoses).

Participants undergo the same standard-of-care non-contrast Computed Tomography (CT) Brain scan that would ordinarily be ordered for clinical management. No additional imaging, radiation exposure, or scan acquisition procedures are required as part of the study. The intervention relates only to the interpretation workflow following image acquisition.

Brief description of the AI tool - The AI tool is Annalise Enterprise V3, a commercially available, TGA-cleared (ARTG 513346) Class IIb software-as-a-medical-device. It functions as a computer-aided detection system that automatically analyses eligible non-contrast CT head scans and provides real-time outputs, visual overlays, and a study-level classification to assist clinician interpretation. The tool provides a binary classification of “remarkable” or “unremarkable” and is intended to support, rather than replace, clinical decision-making.
Intervention code [1] 334669 0
Diagnosis / Prognosis
Description of the comparator or control
Control Group (Standard of Care): Participants will receive standard clinical care. This involves waiting in the ED for the Computed Tomography Brain (CTB) scan to be reviewed by a radiology registrar or consultant, with the provisional report guiding disposition and management decisions. The treating team will be blinded to the AI tool's output.
Control group
Active

Outcomes
Primary outcome [1] 346101 0
Emergency Department length of stay
Timepoint [1] 346101 0
From Emergency Department arrival to discharge
Secondary outcome [1] 464592 0
Patient satisfaction and experience will be assessed as a single secondary outcome
Timepoint [1] 464592 0
At follow-up assessment, prior to discharge
Secondary outcome [2] 465090 0
Rate of adverse events or missed diagnoses. This will be assessed as a single event.
Timepoint [2] 465090 0
Within 24 hours following discharge
Secondary outcome [3] 465091 0
Clinician-AI disagreement rate
Timepoint [3] 465091 0
During Emergency Department encounter

Eligibility
Key inclusion criteria
INCLUSION CRITERIA
• Adults aged 18 years and over
• Presenting complaint of isolated minor head injury or isolated headache
• Glasgow Coma Scale 15
• Non-contrast CTB ordered in ED
• Patient (or person responsible in patients with cognitive impairment) willing and able to provide informed written consent.
• Assessed by treating ED Specialist as likely discharge if CT Brain shows no clinically significant abnormality
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
EXCLUSION CRITERIA
• Serious injury or major trauma on clinical assessment
• Focal neurological defect
• Ongoing Post Traumatic Amnesia
• Acute psychological distress
• Acute drug overdose
• Pre-existing cognitive impairment or acute mental illness

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)
Central randomisation via REDCap
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomisation (REDCap module)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/08/2026
Date of last participant enrolment
Anticipated
26/02/2027
Actual
Date of last data collection
Anticipated
26/02/2027
Actual
Sample size
Target
150
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 29867 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 46221 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 322209 0
Other
Name [1] 322209 0
RPA Green Light Institute
Country [1] 322209 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 325122 0
None
Name [1] 325122 0
Address [1] 325122 0
Country [1] 325122 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320735 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 320735 0
Ethics committee country [1] 320735 0
Australia
Date submitted for ethics approval [1] 320735 0
24/03/2026
Approval date [1] 320735 0
19/05/2026
Ethics approval number [1] 320735 0

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

Contacts
Principal investigator
Name 151454 0
Prof Michael Dinh
Address 151454 0
Royal Prince Alfred Hospital SLHD. Research Hub, Level 2 Gloucester House Missenden Road, Camperdown NSW 2050
Country 151454 0
Australia
Phone 151454 0
+61 2 95159091
Fax 151454 0
Email 151454 0
[email protected]
Contact person for public queries
Name 151455 0
Radhika Seimon
Address 151455 0
Royal Prince Alfred Hospital SLHD. Research Hub, Level 2 Gloucester House Missenden Road, Camperdown NSW 2050
Country 151455 0
Australia
Phone 151455 0
+61 2 95159091
Fax 151455 0
Email 151455 0
[email protected]
Contact person for scientific queries
Name 151456 0
Radhika Seimon
Address 151456 0
Royal Prince Alfred Hospital SLHD. Research Hub, Level 2 Gloucester House Missenden Road, Camperdown NSW 2050
Country 151456 0
Australia
Phone 151456 0
+61 2 95159091
Fax 151456 0
Email 151456 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Data subject to NSW Health governance, privacy and security restrictions



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.