Measuring brain injury markers (GFAP and UCH-L1) to predict concussion

ISRCTN ISRCTN18334572
DOI https://doi.org/10.1186/ISRCTN18334572
Secondary identifying numbers 173
Submission date
23/05/2025
Registration date
11/06/2025
Last edited
27/05/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) have been shown to be released in people who have suffered from severe head injuries that show up on brain scans.
These markers have been used as a rule-out test for Computerised Tomography (CT) scans in patients presenting with head injuries. However, the low specificity of the test means that they are raised in many patients with a normal CT scan. This same study showed that patients with higher biomarker levels had poorer outcomes at 3 months.
Concussion is often underdiagnosed in athletes and the general population, resulting in poor management and prolonged recovery. Undiagnosed concussion could present a danger to athletes participating in sports requiring a high level of concentration, such as motorbike racing.
We suspect that patients who have elevated levels of GFAP and UCH-L1 may have a greater incidence of concussion and should undergo screening for a safe return to sport.
This study aims to see if there is a correlation between raised brain injury markers (GFAP and UCH-L1) and symptoms of concussion in patients with a normal CT of their head following head injury.

Who can participate?
Competitors in the 2025 Isle of Man TT who are injured during a race or practice session and require a CT scan of their head but are able to give consent

What does the study involve?
Blood samples will be taken to measure GFAP and UCH-L1 and participants will be followed up 2 weeks later to perform the Sports Concussion Assessment Tool (Version 6).

What are the possible benefits and risks of participating?
No obvious risks or benefits to participants

Where is the study run from?
Noble’s Hospital (Isle of Man)

When is the study starting and how long is it expected to run for?
May 2025 to June 2025

Who is funding the study?
Manx Care (Isle of Man)

Who is the main contact?
Dr David Frazer, david.frazer@nobles.dhss.gov.im

Contact information

Dr David Frazer
Public, Scientific, Principal Investigator

Emergency Department
Noble's Hospital
Strang
IM4 4RJ
Isle of Man

Phone +44 (0)1624650366
Email david.frazer@gov.im

Study information

Study designSingle-centre diagnostic evaluation study
Primary study designObservational
Secondary study designCase series
Study setting(s)Other
Study typeDiagnostic
Participant information sheet Not available in web format
Scientific titleMeasurement of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) to predict symptoms of concussion in high-energy trauma
Study objectivesCan measurement of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) predict symptoms of concussion in high energy trauma?
Ethics approval(s)

Approved 12/05/2025, Isle of Man Research Ethics Committee (Public Health Directorate Cabinet Office, Isle of Man Government, Strang, IM4 4RJ, Isle of Man; +44 (0)1624 685765; adam.dempsey@gov.im), ref: 174

Health condition(s) or problem(s) studiedConcussion
InterventionThe patient has fallen off a motorcycle and is having a computerised tomography scan of their head to assess injury. They must be conscious and able to provide consent. Blood taken as part of their routine management is also tested for measurement of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1). CT head is performed. 2-3 weeks later they are contacted to undergo screening for concussion using a questionnaire from the Sports Concussion Assessment Tool (version 6) and the score is correlated with the results of the brain injury markers.
Intervention typeOther
Primary outcome measure1. Glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) measured using blood test using Abbott i-STAT GFAP/UCH-L1 cartridge point of care testing at time of arrival in the emergency department
2. Screening for concussion using a questionnaire from the Sports Concussion Assessment Tool (version 6) at 2 to 3 weeks following injury by telephone
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date12/05/2025
Completion date08/06/2025

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants30
Key inclusion criteriaCompetitors in the 2025 Isle of Man TT who are injured during a race or practice session and require a CT scan of their head
Key exclusion criteriaUnable to give consent
Date of first enrolment25/05/2025
Date of final enrolment08/06/2025

Locations

Countries of recruitment

  • Isle of Man

Study participating centre

Noble's Hospital
Emergency Department
Strang
IM4 4RJ
Isle of Man

Sponsor information

Manx Care
Hospital/treatment centre

Emergency Department
Strang
IM4 4RJ
Isle of Man

Phone +44 (0)1624650366
Email Lesley.Clyde@nobles.dhss.gov.im
Website https://www.gov.im/about-the-government/statutory-boards/manx-care/

Funders

Funder type

Hospital/treatment centre

Manx Care

No information available

Results and Publications

Intention to publish date01/06/2026
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a peer reviewed journal
IPD sharing planThe data sharing plans are currently unknown and will be made available at a later date

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file 27/05/2025 No No

Additional files

47391_PROTOCOL.pdf

Editorial Notes

23/05/2025: Study's existence confirmed by the Isle of Man Research Ethics Committee.