BRaINS-TBI

Scientific Title:

Biomarkers for RAtional Investigation for Neurological Decision Support in traumatic brain injury (BRaINS-TBI): cohort study with a nested pragmatic randomised trial

Chief Investigator:

Dr Virginia Newcombe, University of Cambridge and Cambridge University Hospitals NHS Foundation Trust

Funder:

National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation (EME) Programme
(Project Reference: NIHR159241)

Sponsor:

Cambridge University Hospitals NHS Foundation Trust and University of Cambridge

Health Condition or Problem Studied:

Patients who attend Emergency Departments (EDs) following a mild traumatic brain injury (mTBI), defined as a Glasgow Coma Scale (GCS) score greater than 12.

Study Design

BRaINS-TBI is a UK-wide study investigating how blood biomarkers can improve the assessment and management of people who attend the ED with a mild traumatic brain injury.

The study will test whether specific blood biomarkers can:

• Help doctors decide who needs a CT scan, and

• Predict which patients may experience long-term symptoms and benefit from targeted follow-up.

The study has two main components:

Observational Cohort Study – BRaINS-TBI Predict

An observational cohort of 2,082 patients with mTBI presenting to participating EDs.

• Blood samples and clinical data will be collected during the ED visit.

• Participants will be followed up at approximately 2 weeks, 3 months and 6 months after injury to assess recovery, symptoms, and day-to-day functioning.

• Biomarkers (including GFAP and UCH-L1) will be analysed to determine how well they predict CT findings and long-term outcomes.

Two comparison groups will also be recruited:

• 200 healthy volunteers

• 200 non-head injury trauma controls

These control groups will allow researchers to understand how biomarker levels differ in people without head injuries or with injuries elsewhere in the body.

Nested Pragmatic Randomised Trial – BRaINS-TBI CT

Within the main cohort, 954 participants will take part in a randomised trial.

• Participants will be allocated to either standard care or care guided by biomarker test results (using the i-STAT TBI assay, Abbott Point of Care Inc.).

• This will test whether having real-time biomarker results helps clinicians make better decisions about CT scans and follow-up care.

Additional Work Packages

BRaINS-TBI Communication (Qualitative study):
Workshops and interviews with healthcare professionals and patients to understand experiences, communication, and practical considerations in implementing biomarker-guided care.

Health Economic Evaluation:
Analysis of the cost-effectiveness and impact of biomarker-guided decision-making across NHS emergency departments.

Status

In set-up

Contact Details:

Study queries (sites and collaborators): brains-tbi.trial@uea.ac.uk​

Public and scientific queries: Virginia Newcombe, vfjn2@cam.ac.uk​