About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
unconscious patients as well as patients for whom the head trauma occurred at least 6 hours before presenting to the emergency room
Trial population
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.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
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.
Sponsors and contacts
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