Using blood biomarkers to assess minor traumatic brain injuries in the emergency department
Use of Cerebral Biomarkers in Minor Traumatic Brain Injury in the Emergency Unit
This study is testing if certain blood markers can help doctors quickly diagnose minor brain injuries in adults who come to the emergency room.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1510 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Roma) |
| Trial ID | NCT06069674 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of serum biomarkers, specifically glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1), in diagnosing minor traumatic brain injuries (mTBI) in patients presenting to the emergency department. Patients over 18 years old who meet specific criteria will have their blood sampled and undergo serial brain CT scans as part of their standard care. The study will analyze data collected over 18 months, including both retrospective and prospective patient enrollments, to determine the biomarkers' ability to distinguish between those with and without acute brain injury.
Who should consider this trial
Good fit: Ideal candidates for this study are non-pregnant adults over 18 years old who present to the emergency department within 4 hours of a traumatic event and report symptoms of minor traumatic brain injury.
Not a fit: Patients under 18 years old, pregnant women, or those who refuse to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of diagnosing minor traumatic brain injuries, leading to better patient management and outcomes.
How similar studies have performed: Previous multicenter studies have shown success in using similar serum biomarkers for diagnosing traumatic brain injuries, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients ≥18 years old; * Patients who present to the ED within 4 hours since a traumatic event and reporting mTBI. * Patients who own risk factors for delayed intracranial bleeding, defined as: history of anticoagulant therapy (VKA or DOACs) or known coagulopathy. * Patients who undergo serial CT scan during the emergency evaluation as part of the standard ED care and if a sample of venous blood will be obtained at the moment of the visit. * Signed written informed consent to study participation and personal data treatment. Exclusion Criteria: * Age \<18 years old; * Pregnant women; * Refusal to sign written informed consent to study participation and personal data treatment.
Where this trial is running
Roma
- Fondazione Policlinico Universitario "A. Gemelli" IRCCS — Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Marcello Covino, Dr.
- Email: marcello.covino@policlinicogemelli.it
- Phone: 0630153162
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.