Single-center Transversal Observational Study on the Evaluation of S100B Changes in Subjec
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, sup
| Condition(s) | Head Trauma |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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). |
| Who can participate | 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 |
| Ages | 100 Years |
| Sex | All |
| Lead sponsor | IRCCS San Raffaele |
| Locations | Milan, Milano, Italy |
| Start date | 2025-09-01 |
| NCT ID | NCT07036146 |
| Official listing | https://clinicaltrials.gov/study/NCT07036146 |