Actively Recruiting
Single-center Transversal Observational Study on the Evaluation of S100B Changes in Subjects Attending the Emergency Department With Head Trauma
Led by IRCCS San Raffaele · Updated on 2025-09-24
1000
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of the study is to evaluate blood levels of the calcium-binding protein S100B as a diagnostic biomarker for the management of patients with suspected traumatic brain injury. With a sensitivity of 97% and a negative predictive value greater than 99%, S100B measurement can predict the absence of brain injury, supporting risk stratification and the safe discharge of low-risk patients. This, in turn, may reduce the need for imaging studies and shorten emergency department stays. The management of patients enrolled in the study will be identical to that of non-enrolled patients. The only difference is that patients in the study will undergo a blood draw, whereas in routine practice blood tests are not mandatory (although they are often performed).
CONDITIONS
Official Title
Single-center Transversal Observational Study on the Evaluation of S100B Changes in Subjects Attending the Emergency Department With Head Trauma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 0 to 100 years
- Signed informed consent to participate in the study
- Admitted to the emergency department with head trauma occurring less than 6 hours before admission
- Includes pregnant and breastfeeding women
- Unconscious patients who regain consciousness within 6 hours of trauma
You will not qualify if you...
- Patients currently unconscious who have not regained consciousness
- Head trauma occurred 6 hours or more before presenting to the emergency department
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS Ospedale San Raffaele
Milan, Milano, Italy, 20132
Actively Recruiting
Research Team
E
Eleonora Sabetta, Doctor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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