NCT07036146 Single-center Transversal Observational Study on the Evaluation of S100B Changes in Subjects Attending the Emergency Department With Head Trauma
| NCT ID | NCT07036146 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele |
| Condition | Head Trauma |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2025-09-01 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07036146 clinical trial?
This trial is open to participants of all sexes, up to 100 Years, studying Head Trauma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07036146 currently recruiting?
Yes, NCT07036146 is actively recruiting participants. Contact the research team at sabetta.eleonora@hsr.it for enrollment information.
Where is the NCT07036146 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07036146 clinical trial?
NCT07036146 is sponsored by IRCCS San Raffaele. The trial plans to enroll 1,000 participants.