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Clinical Trials in Italy / NCT07036146
Recruiting Observational

Single-center Transversal Observational Study on the Evaluation of S100B Changes in Subjects Attending the Emergency Department With Head Trauma

NCT07036146 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS San Raffaele
Phase
Observational
Started
2025-09-01
Last updated
2025-09-24

Condition(s) studied

Head Trauma

Study summary

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).

Eligibility

Sex
ALL
Min age
—
Max age
100 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Verify and confirm the correlation between blood S100B levels (>0.1 µg/L) and head trauma severity as determined by the GCS and clinical symptoms — Blood sampling at day 0 (at ED admission)
    The concentration of S100B in the blood will be measured in patients admitted to the Emergency Department with head trauma. Correlations between blood S100B levels and head trauma severity as determined by the GCS and clinical symptoms will be assessed.

Trial sites (1)

FacilityCityRegionStatus
IRCCS Ospedale San Raffaele Milan Milano Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07036146 on ClinicalTrials.gov ↗ ← All trials in Italy