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

NCT07036146 | Recruiting DMC

• 1 other identifier: SMART
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Head Trauma

Outcome Measures

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.

  Blood sampling at day 0 (at ED admission)

Study Arms (1)

Subjects admitted at the ED with head trauma, regardless of age or gender

Eligibility Criteria

• Age: Up to 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• unconscious patients as well as patients for whom the head trauma occurred at least 6 hours before presenting to the emergency room

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Milano, 20132, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Venus blood withdrawal (approximately 3-5 mL)

MeSH Terms

Conditions

Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Central Study Contacts

Eleonora Sabetta, Doctor

CONTACT

+39 0226435288; sabetta.eleonora@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)