Improving research and care for people with traumatic brain injury
| ISRCTN | ISRCTN98883107 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98883107 |
| Integrated Research Application System (IRAS) | 351717 |
| Central Portfolio Management System (CPMS) | 66498 |
| Medical Research Council (MRC) Grant Codes | MR/Y008502/1 |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust |
| Funder | Medical Research Council |
- Submission date
- 12/08/2026
- Registration date
- 15/09/2026
- Last edited
- 15/09/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Traumatic brain injury (TBI) affects millions of people worldwide and can have long-lasting effects on physical health, thinking, emotions, and quality of life. However, doctors and researchers still do not fully understand why people recover differently after similar injuries. Better information is needed to improve diagnosis, predict recovery, and develop more effective treatments for future patients. The 3P Study is part of the UK TBI-REPORTER programme, a national research initiative designed to improve understanding of traumatic brain injury. The study aims to test whether researchers across hospitals in the UK can collect information in a consistent way from people with different types and severities of TBI. Researchers will collect information from medical records, brain scans, blood and other biological samples, brain activity recordings, and follow-up assessments of recovery. The information gathered will be used to create a national research resource that will support future studies and help improve the care and outcomes of people living with traumatic brain injury.
Who can participate?
Adults diagnosed with a traumatic brain injury who receive care at a participating hospital.
What does the study involve?
Participants will be asked to allow researchers to collect information about their injury and treatment, provide blood samples, take part in follow-up assessments, and may also be invited to have brain scans and brain activity tests.
What are the possible benefits and risks of participating?
Taking part is unlikely to benefit participants directly, but the information collected may help improve understanding, diagnosis and treatment of traumatic brain injury for future patients. Risks are low but may include discomfort or bruising from blood samples, inconvenience from study visits, and possible discomfort during MRI scans or other assessments.
Where is the study run from?
University of Cambridge, UK.
When is the study starting and how long is it expected to run for?
The study started in June 2025 and is expected to finish in March 2029.
Who is funding the study?
UK Research and Innovation (UKRI) Medical Research Council, UK.
Who is the main contact?
Joanne Outtrim, TBI-REPORTER@medschl.cam.ac.uk
Contact information
Principal investigator, Scientific, Public
University of Cambridge, Box 93, Department of Medicine, Addenbrooke’s Hospital, Hills Road
Cambridge
CB2 0QQ
United Kingdom
| Phone | +44 (0)1223 330758 |
|---|---|
| TBI-REPORTER@medschl.cam.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Cohort study |
| Scientific title | TBI-REPORTER prospective proof of principle study |
| Study acronym | 3P Study |
| Study objectives | The 3P TBI reporter study aims to: 1. Establish the feasibility of a standardised, national TBI (Traumatic Brain Injury, Head Injury) reporting network 2. Refine a core data and biosample collection protocol for acute and chronic TBI studies to be further utilised across the TBI REPORTER platform 3. Evaluate the clinical feasibility of the TBI REPORTER data repository 4. Provide pilot data for sample size calculation in future EMN studies |
| Ethics approval(s) |
Approved 15/05/2025, East of England - Cambridge Central Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; -; cambridgecentral.rec@hra.nhs.uk), ref: 25/EE/0055 |
| Health condition(s) or problem(s) studied | Injuries to the head |
| Methodology | The 3P study is a prospective observational study that will recruit up to 350 TBI patients across all severity levels at 7 sites over 24 months. Patients will be enrolled upon hospital presentation (ED, ward, ICU and clinic) and followed for up to 2 years to track their recovery from acute injury onward. The 3P data collection will be divided into five groups based on clinical care pathways at enrolment: - ED cohort: patients evaluated in the ED and discharged (n=100) - Ward cohort: patients admitted to the hospital but not to ICU (n=100) - ICU cohort: patients admitted directly from the ED or other hospital to the ICU (n=100) - Chronic cohort: patients presenting more than 6 months after initial TBI (up to 50) - Healthy volunteers: volunteer subjects at each centre for MR study (up to 100) All patients will be screened for eligibility before informed consent is obtained. In the case of patients who are assessed as not having capacity, a consultee/proxy will be approached as set out in the Mental Capacity Act 2005/Adults with Incapacity (Scotland) Act 2000. There are core data modules to which patients can take part, although some parts of the study may not be available depending on local resources. The 3P baseline data clinical variables will be prospectively collected from all enrolled patients, through medical records and personal interviews, and will include, for example: • Demographic information • Socioeconomic information • Medical history • Mechanism of injury • Pre-hospital clinical course variables • Brain CT report • Emergency department clinical course • Hospital admission clinical course • Hospital therapies, surgeries and neuromonitoring • Admission and discharge information • Acute care outcome evaluation • Biomarker samples • 12-lead ECG and rhythm strip The 3P study will collect bodily fluid samples (blood, CSF, urine, and faeces) to identify substances that may influence the body's response to and recovery from TBI. Centres in the MR data collection arm will use 3 Tesla scanners for MR brain scans. Some will perform ultra-early scans within 72 hours of TBI, while others will scan within 5 days, aiming to scan all patients within 2-3 weeks. Each participant will typically have two MRIs: one during the acute stage and one at follow-up (6, 12, or 24 months). Chronic cohort participants may have up to four MRIs over 24 months. Patients may be invited for follow-up visits over 2 years, including blood sampling, neurocognitive tests, and quality-of-life questionnaires at various time points. At sites with MRI and EEG facilities, additional MRI scans and EEG tests may be done. The length of visits will vary, as some tasks, like questionnaires and cognitive tests, can be completed online or by phone. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 01/03/2029 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 450 |
| Key inclusion criteria | 3P acute cohort inclusion criteria: 1. Clinical diagnosis of TBI 2. Consideration for CT scan based on NICE screening criteria 3. Presentation within 24 hours of injury 4. Informed consent/consultee agreement obtained according to local and national requirements 5. > = 18 years of age 3P chronic cohort inclusion criteria: 1. Clinical diagnosis of TBI 2. Consideration for CT scan based on NICE screening criteria 3. > = 6 months after TBI 4. Informed consent obtained according to local and national requirements 5. > = 18 years of age 6. Able to engage with biosample, MRI and outcome assessments Healthy volunteer inclusion criteria: 1. > = 18 years of age 2. Informed consent agreement received |
| Key exclusion criteria | 3P acute cohort exclusion criteria: The following will be assessed on a case-by-case basis: 1. Severe pre-existing neurological disorder that would confound outcome assessments. In practical terms, this would exclude individuals who, because of a neurological disease, would be assessed as having pre-injury moderate disability (or worse) on the Glasgow Outcome Score (GOSE < 6). 2. Patients who may have difficulties in understanding written or verbal information in English that would limit their ability to consent and complete the outcome assessments. 3. Patients who have a catastrophic injury where death is expected within 24 hours of injury. Chronic cohort exclusion criteria: The following will be assessed on a case-by-case basis: 1. Severe pre-existing neurological disorder that would confound outcome assessments. In practical terms, this would exclude individuals who, because of a neurological disease, would be assessed as having pre-injury moderate disability (or worse) on the Glasgow Outcome Score (GOSE < 6). 2. Patients who have difficulties in understanding written or verbal information in English that would limit their ability to consent and complete the outcome assessments. Healthy volunteer exclusion criteria: 1. Significant neurological or systemic disease (American Society of Anaesthesiologists Grade 1 or 2) 2. History of TBI requiring hospital attendance or medical input |
| Date of first enrolment | 12/06/2025 |
| Date of final enrolment | 01/03/2029 |
Locations
Countries of recruitment
- United Kingdom
- England
- Scotland
Study participating centres
Cambridge
CB2 0QQ
England
London
W2 1NY
England
London
SE5 9RS
England
Old Dalkeith Road
Edinburgh
Lothian
EH16 4SA
Scotland
Glasgow
G51 4TF
Scotland
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan | De-identified data generated and/or analysed during this study will be made available through the Dementias Platform UK (DPUK) Data Portal (https://portal.dementiasplatform.uk/), subject to relevant approvals and governance requirements. Approved researchers from academic, healthcare, governmental, or commercial institutions will be able to access the data through the secure DPUK/TBI-REPORTER Trusted Research Environment for scientifically and ethically approved research purposes. Data will be made available following study completion and publication of primary findings and will remain available in accordance with repository policies. Only de-identified data will be shared, with access governed by participant consent, ethical approvals, data protection legislation, and applicable data access agreements. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Study website | 12/08/2026 | No | No |
Editorial Notes
12/08/2026: Study's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
