S100B blood changes in emergency patients with head trauma
Official title: Single-center Transversal Observational Study on the Evaluation of S100B Changes in Subjects Attending the Emergency Department With Head Trauma
Run by IRCCS San Raffaele · NCT07036146 · Data updated 2026-11-12
This study will test whether a blood test for the protein S100B can reliably rule out brain injury in people who arrive at the ER within six hours of a head injury.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 100 Years |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | IRCCS San Raffaele Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Milan, Milano) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | July 1, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | September 24, 2025 |
| Trial ID | NCT07036146 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People of any sex aged 0–100 who present to the ED within six hours of head trauma and can provide informed consent (or regain consciousness within six hours) are eligible.
✕Probably not a fit
Patients who remain unconscious beyond six hours, who present more than six hours after the injury, or who have clinical indications for immediate imaging or severe TBI are unlikely to benefit from S100B-based CT reduction.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, transversal observational study enrolling patients who present to the emergency department within six hours of head trauma. Participants undergo a routine clinical management pathway identical to non-enrolled patients, with the only difference being a venous blood draw for S100B measurement. Measured S100B levels will be compared with imaging results and clinical outcomes to determine how well the biomarker predicts absence of intracranial injury. The goal is to determine whether early S100B testing can safely reduce unnecessary CT scans and shorten ED stays.
Why it matters
Potential benefit: If successful, using S100B could safely reduce unnecessary head CT scans and shorten emergency department stays for low-risk head-injury patients.
How similar studies have gone: Previous studies have reported high sensitivity (~97%) and negative predictive value (>99%) for early S100B measurement in ruling out intracranial injury, so the approach has supporting evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Either males or female patients, aged 0-100 years, who signed the study informed consent, including pregnant and breastfeeding women admitted at the ED with a head trauma occurred less than 6 hour prior to admission to the ED. Unconscious patients will still be enrolled if they regain consciousness within 6 hours of the trauma Exclusion Criteria: * unconscious patients as well as patients for whom the head trauma occurred at least 6 hours before presenting to the emergency room
Where it's running
-
IRCCS Ospedale San Raffaele
Milan, Milano, Italy Recruiting
Study contacts
- Study coordinator: Eleonora Sabetta, Doctor
- Email: sabetta.eleonora@hsr.it
- Phone: +39 0226435288
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.