BRaINS-TBI
Research type
Research Study
Full title
Biomarkers for RAtional Investigation for Neurological Decision Support in traumatic brain injury (BRaINS-TBI): cohort study with a nested pragmatic randomised trial
IRAS ID
354593
Contact name
Virginia Newcombe
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Duration of Study in the UK
3 years, 0 months, 31 days
Research summary
Biomarkers for RAtional Investigation for Neurological decision Support in TBI (BRaINS-TBI) is a UK-wide research study focused on improving how doctors assess patients who come to the Emergency Department (ED) after a mild traumatic brain injury (mTBI). Over 1 million people attend EDs each year with head injuries. Most are mild, but some lead to longer-term problems or may worsen. Currently, doctors rely on symptoms and CT scans to make decisions, but this is not always accurate.
This study investigates whether blood tests (biomarkers) can help predict who has a brain injury and who may need a CT scan or further support. It also tests whether using these biomarkers as part of decision-making improves patient care.
The study has two parts:
BRaINS-TBI Predict (observational cohort): Patients will have blood samples taken, and data collected during their ED visit and recovery. This will help determine how well different biomarkers predict outcomes. Control groups will include healthy volunteers and non-head injury trauma patients.
BRaINS-TBI CT (nested randomised trial): Some participants will be randomly assigned to a care pathway that includes biomarker test results being shared with clinicians, to see if this changes decisions (e.g., about CT scans).
Participants will be followed up for up to 6 months via phone, online questionnaires, or in-person. The study aims to support safer, more efficient use of healthcare resources, reduce unnecessary scans, and improve long-term outcomes.
The clinical studies will run alongside mixed methods/qualitative studies to communicate outcomes and co-explore risks and findings with clinicians and patient groups, as well as a separate economic evaluation.
REC name
East of England - Essex Research Ethics Committee
REC reference
25/EE/0233
Date of REC Opinion
18 Dec 2025
REC opinion
Further Information Favourable Opinion