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RECRUITING
NCT07036146

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

Sponsor: IRCCS San Raffaele

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

Any - 100 Years

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2025-09-01

Completion Date

2027-12-31

Last Updated

2025-09-24

Healthy Volunteers

No

Conditions

Locations (1)

IRCCS Ospedale San Raffaele

Milan, Milano, Italy