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
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
Public, Scientific, Principal Investigator
Emergency Department
Noble's Hospital
Strang
IM4 4RJ
Isle of Man
| Phone | +44 (0)1624650366 |
|---|---|
| david.frazer@gov.im |
Study information
| Study design | Single-centre diagnostic evaluation study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Other |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format |
| Scientific title | Measurement of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) to predict symptoms of concussion in high-energy trauma |
| Study objectives | Can 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) studied | Concussion |
| Intervention | The 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 type | Other |
| Primary outcome measure | 1. 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 measures | There are no secondary outcome measures |
| Overall study start date | 12/05/2025 |
| Completion date | 08/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | Unable to give consent |
| Date of first enrolment | 25/05/2025 |
| Date of final enrolment | 08/06/2025 |
Locations
Countries of recruitment
- Isle of Man
Study participating centre
Strang
IM4 4RJ
Isle of Man
Sponsor information
Hospital/treatment centre
Emergency Department
Strang
IM4 4RJ
Isle of Man
| Phone | +44 (0)1624650366 |
|---|---|
| Lesley.Clyde@nobles.dhss.gov.im | |
| Website | https://www.gov.im/about-the-government/statutory-boards/manx-care/ |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer reviewed journal |
| IPD sharing plan | The 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
Editorial Notes
23/05/2025: Study's existence confirmed by the Isle of Man Research Ethics Committee.
