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

ConditionHead Trauma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 100
SponsorIRCCS San Raffaele

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group
Group A: Subjects admitted at the ED with head trauma, regardless of age or gender

Trial outcomes

Primary outcomes

1

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.

Time frame
Blood sampling at day 0 (at ED admission)

Secondary outcomes

Other outcomes

Sponsors and contacts

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