RecruitingNot ApplicableInterventional

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

Every year, many people go to A&E with head injuries in the UK. Most are mild, but some can cause serious problems. Doctors currently use symptoms and scans, but these aren't always perfect. The BRaINS-TBI study is testing a simple blood test that looks for tiny 'biomarkers' which might show if someone has a brain injury. The study hopes this could help doctors make better decisions, avoid unnecessary CT scans, and improve care. People with mild head injuries, healthy volunteers, and those with other injuries might be asked to join. It involves giving blood samples and sharing information about recovery over six months.

At a glance

Status

Recruiting

Phase

Not Applicable

Enrolment target

2,482

Start

19 Feb 2026

Estimated completion

30 Jun 2027

Traumatic brain injury

What is this study about?

When you have a head injury, it's really important for doctors to quickly understand how serious it is. Currently, they often rely on symptoms and brain scans (like CT scans) to make these decisions. However, sometimes these methods aren't quite accurate enough, meaning some people might have unnecessary scans, while others might not get the right attention they need.

This study, called BRaINS-TBI, is looking into a new way to help doctors. It's testing a simple blood test that searches for special 'signals' in your blood, called biomarkers. These signals could show if your brain has been injured. Think of it like a special message in your blood that tells doctors more about what's going on inside your head.

The main goal is to see if using this blood test can help doctors get a clearer picture of your head injury. They want to find out if it can lead to better decisions about your care and potentially reduce the number of people who need to have a CT scan when it's not truly necessary. Ultimately, this could mean better care and better recovery for people with head injuries in the future.

Key takeaways

Tests a new blood test for head injuries in A&E.
Aims to help doctors make better decisions and reduce unnecessary CT scans.
Participation involves a blood sample and sharing recovery information.
Follow-up lasts about six months, usually by phone or online.
Could help improve future head injury care.
All personal information is kept private.

Who may be eligible?

You might be able to take part in this study if you are 16 years or older and come to A&E within 24 hours of a head injury. This includes if you have a mild head injury, meaning your consciousness score (Glasgow Coma Score) is 13, 14, or 15, and doctors are thinking about whether you need a CT scan based on standard guidelines.

The study also needs volunteers who haven't had a head injury. This includes people 16 years or older who have come to A&E with an injury to another part of their body (not their head) within 24 hours, or healthy adults 16 years or older with no injuries at all. This helps the researchers compare results and understand what's normal.

You wouldn't be able to join if you can't understand English well enough to give consent and complete the assessments, or if you're unable to give your own permission to join and there's no one legally able to do it for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 16 years or older?
Did you come to A&E within 24 hours of your head injury?
Do doctors currently need to decide if you should have a CT scan for your head injury?
Are you able to provide consent and understand information in English?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to give a blood sample. This is like a standard blood test you might have for other medical reasons. You'll also be asked to share information about your head injury and how you recover. Some people will be randomly chosen to have their blood test results shared with their doctor, to see if it helps guide their care decisions.

The study involves following up on your recovery for about six months after your injury. This follow-up might happen over the phone, through online questionnaires you fill out, or sometimes in person. The total duration of your participation, from your A&E visit to the end of the follow-up, will be around six months.

Potential risks and benefits

Taking part in this study could really help improve future care for people with head injuries, potentially leading to fewer unnecessary CT scans and a better long-term recovery for many. The risks are very low; giving a blood sample is a common and safe procedure. All your personal information will be kept private and confidential. Remember, joining is completely your choice, and you can change your mind and leave the study at any time without it affecting your medical care.

Locations (13)

Cambridge University Hospitals NHS Foundation Trust
City only
Cambridge, England
NHS Grampian
Approximate
Aberdeen, Scotland
University Hospitals of Derby and Burton NHS Foundation Trust
City only
Derby, England
Greater Glasgow and Clyde
City only
Glasgow, Scotland
Liverpool University Hospitals NHS Foundation Trust
City only
Liverpool, England
Oxford University Hospitals NHS Foundation Trust
Unverified
Oxford, England
University Hospitals Plymouth NHS Trust
Unverified
Plymouth, England
Royal Berkshire NHS Foundation Trust
Unverified
Reading, England
Northern Care Alliance NHS Foundation Trust
Unverified
Salford, England
Sheffield Teaching Hospitals NHS Foundation Trust
Unverified
Sheffield, England
Barts Health NHS Trust
Unverified
London, England
Swansea Bay University Local Health Board
Unverified
Neath, Wales

Common questions

What is a 'biomarker'?

A biomarker is like a tiny signal or message found in your blood that can tell doctors important things about your health, such as if you have an injury.

Will this blood test replace CT scans immediately?

No, this study is testing if the blood test can help doctors make better decisions alongside current methods, possibly reducing the need for some CT scans, but it's not a replacement yet.

How long will I be involved in the study?

If you take part, you will be followed up for about six months after your head injury.

What does a 'mild head injury' mean?

In this study, a mild head injury generally means you might have been dazed or confused but you didn't lose consciousness for a long time, and doctors are assessing whether you need a scan.

Who is paying for this research?

The study is funded by the National Institute for Health and Care Research (NIHR), a major health research funder in the UK.

How to find out more

Virginia Newcombe

vfjn2@cam.ac.uk +44 1223586585 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.