Point of Care Testing in Emergency Departments After Mild Traumatic Brain Injury (POCkET)

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Injuries, Head; Traumatic Brain Injuries

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: POCkET Study Coordinator; Phone Number: +4401603 591745; Email: pocket.study@uea.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who present to Emergency Departments (EDs) with mild traumatic brain injury (mTBI) defined as Glasgow Coma Score >12.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Understanding of the current clinical pathway and how use of point of care biomarkers may change this.	From enrolment to 6 months

Collaborators and Investigators

• Sponsor: Cambridge University Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): August 29, 2026
• Study Completion (Estimated): August 29, 2026

Study Registration Dates

• First Submitted: August 12, 2025
• First Submitted That Met QC Criteria: August 12, 2025
• First Posted (Actual): August 19, 2025

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries, Traumatic; Wounds and Injuries; Brain Injuries; Brain Concussion; Craniocerebral Trauma
• Other Study ID Numbers: IRAS 353032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No