Injuries, HeadPOCkETNCT07129577
Point of Care Testing in Emergency Departments After Mild Traumatic Brain Injury
An observational study of Injuries, Head and Traumatic Brain Injuries, run by Cambridge University Hospitals NHS Foundation Trust.
Trial summary
Traumatic brain injury (TBI) is estimated to have the highest incidence of all common neurological disorders, affecting 50 to 60 million people worldwide each year. In the UK, approximately one million people attend an Emergency Department (ED) annually following a head injury, and 80-90% of these are classified as… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Injuries, Head, Traumatic Brain Injuries
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 29 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who present to Emergency Departments (EDs) with mild traumatic brain injury (mTBI) defined as Glasgow Coma Score >12.
Who may be able to join
- Adult patients (≥ 18 years of age)
- Glasgow Coma Score >12
- Presentation within 24 hours of head injury
- Meet criteria to be assessed using NICE NG232 clinical decision support tool (CDST).
- Patients with a prior history of TBI may still be included.
Who cannot join
- Participant without capacity and no available patient legal representative or professional consultee.
- Participant with capacity unwilling to provide informed consent
- Unable to adequately understand written and verbal English.
- Prisoners currently in custody of HM Prison Service
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Point of Care Testing in Emergency Departments After Mild Traumatic Brain Injury (POCkET)
Traumatic brain injury (TBI) is estimated to have the highest incidence of all common neurological disorders, affecting 50 to 60 million people worldwide each year. In the UK, approximately one million people attend an Emergency Department (ED) annually following a head injury, and 80-90% of these are classified as mild TBI (mTBI), also referred to as concussion. In the acute setting, mTBI is typically defined by a Glasgow Coma Scale (GCS) score of 13-15 on presentation.
Current acute management focuses primarily on identifying which patients require a CT head scan to detect life threatening injuries that may need neurosurgical intervention, observation, or neurocritical care. However, there is increasing recognition that the term "mild" can be misleading. Many patients, including those with normal CT scans,experience persistent functional, cognitive, and symptomatic deficits that may benefit from further intervention and follow-up care.
Read more
Blood biomarkers offer significant potential to improve the early diagnosis, risk stratification, and prognostication of mTBI in the ED setting. While these biomarkers are increasingly being developed and evaluated in moderate and severe TBI, their clinical utility in mild TBI has not yet been definitively demonstrated.
To fully assess their potential value, it is essential to understand the current care pathways for mTBI in the ED, how they are implemented in practice, and where biomarker information could meaningfully enhance clinical decision making and improve patient outcomes.
The POCKET study will use a systems engineering approach, in combination with health economic evaluation, to assess the potential role and utility of point-of-care blood biomarkers in the management of mild TBI in UK emergency departments. This research will be conducted using the Abbott biomarker platform.
- Conditions
- Injuries, Head, Traumatic Brain Injuries
- Medical subject headings
- Craniocerebral Trauma, Brain Injuries, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Understanding of the current clinical pathway and how use of point of care biomarkers may change this.
Measured: From enrolment to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion29 Aug 2026 (estimated)
- Study completion29 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injuries, HeadStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virginia Newcombe, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129577
- Sponsor's protocol ID
- IRAS 353032
- Acronym
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Testing in Emergency Departments After Mild Traumatic Brain Injury (POCkET)
- ClinicalTrials.gov ID
- NCT07129577
- Acronym / sponsor ID
- POCkET / IRAS 353032
- Conditions
- Injuries, Head, Traumatic Brain Injuries
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 29 Aug 2026 (estimated)
- Study completion
- 29 Aug 2026 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Traumatic brain injury (TBI) is estimated to have the highest incidence of all common neurological disorders, affecting 50 to 60 million people worldwide each year. In the UK, approximately one million people attend an Emergency Department (ED) annually following a head injury, and 80-90% of these are classified as mild TBI (mTBI), also referred to as concussion. In the acute setting, mTBI is typically defined by a Glasgow Coma Scale (GCS) score of 13-15 on presentation.
Current acute management focuses primarily on identifying which patients require a CT head scan to detect life threatening injuries that may need neurosurgical intervention, observation, or neurocritical care. However, there is increasing recognition that the term "mild" can be misleading. Many patients, including those with normal CT scans,experience persistent functional, cognitive, and symptomatic deficits that may benefit from further intervention and follow-up care.
Blood biomarkers offer significant potential to improve the early diagnosis, risk stratification, and prognostication of mTBI in the ED setting. While these biomarkers are increasingly being developed and evaluated in moderate and severe TBI, their clinical utility in mild TBI has not yet been definitively demonstrated.
To fully assess their potential value, it is essential to understand the current care pathways for mTBI in the ED, how they are implemented in practice, and where biomarker information could meaningfully enhance clinical decision making and improve patient outcomes.
The POCKET study will use a systems engineering approach, in combination with health economic evaluation, to assess the potential role and utility of point-of-care blood biomarkers in the management of mild TBI in UK emergency departments. This research will be conducted using the Abbott biomarker platform.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present to Emergency Departments (EDs) with mild traumatic brain injury (mTBI) defined as Glasgow Coma Score >12.
Key inclusion criteria (5 listed)
- Adult patients (≥ 18 years of age)
- Glasgow Coma Score >12
- Presentation within 24 hours of head injury
- Meet criteria to be assessed using NICE NG232 clinical decision support tool (CDST).
- Patients with a prior history of TBI may still be included.
Key exclusion criteria (4 listed)
- Participant without capacity and no available patient legal representative or professional consultee.
- Participant with capacity unwilling to provide informed consent
- Unable to adequately understand written and verbal English.
- Prisoners currently in custody of HM Prison Service
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Understanding of the current clinical pathway and how use of point of care biomarkers may change this.
Time frame: From enrolment to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Injuries, Head and Traumatic Brain Injuries, run by Cambridge University Hospitals NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact POCkET Study Coordinator (+4401603 591745, pocket.study@uea.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Understanding of the current clinical pathway and how use of point of care biomarkers may change this. (time frame: From enrolment to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.