Head TraumaNCT07036146
Single-center Transversal Observational Study on the Evaluation of S100B Changes in Subjects Attending the Emergency Department With Head Trauma
An observational study of Head Trauma, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Head Trauma
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- unconscious patients as well as patients for whom the head trauma occurred at least 6 hours before presenting to the emergency room
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Milano, 20132
Federico Furlan, MD, 0226438379, furlan.federico@hsr.it
About this study
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).
Read the detailed description
Traumatic brain injury (TBI) is a leading cause of death and hospital admissions worldwide, with over 50 million new cases occurring globally annually. Based on the severity, brain traumas have been classified in four different categories: Minimal, Mild, Moderate and Severe TBI. Mild and Moderate TBI (mTBI), represents the vast majority of TBIs occurring in the ED. Imaging techniques, such as computed tomography (CT), are traditionally the most widely used diagnostic method in evaluating a patient with suspected mTBI. However, only approximately 16% of patients attending the ED with suspected mTBI present intracranial lesions (proved with imaging techniques). Furthermore, the diagnostic process based on imaging techniques involves an average stay in the ED of approximately 7 hours. Despite the low diagnostic yield, the high cost and the potential side effect of the ionizing radiation, the use of imaging techniques is supported on the basis that even a mTBI can hide a serious, life-threatening injury.
In this context, the beta subunit of the calcium binding protein S100B has emerged as a highly diagnostic biomarker in the management of TBI, and in particular for mTBI, if the measurement is performed within the first hours of trauma. S100B can be detected with a simple and rapid routine venous blood test, making its use minimally invasive for the patient and extremely more efficient (both in terms of costs and time) for the hospital. Thanks to a sensitivity of 97% associated with a negative predictive value >99%, the S100B dosage can predict the absence of brain damage, facilitating risk stratification and safe discharge of low-risk patients allowing the reduction of the number of imaging tests, and consequently the patient's length of stay in the ED.
The S100B dosage is therefore an objective tool for patient triage. It is simpler and faster to perform than imaging techniques and involves reduced treatment costs which can be estimated at approximately 100 euros per patient.
The implementation of the S100B dosage in a clinical/diagnostic routine becomes even more important in pediatric settings. It has been shown that exposure to ionizing radiation at a young age (0-19 years) can increase the risk of cancer by up to 24%. In this context, S100B has proven to be a very promising biomarker for children with mTBI. A meta-analysis of eight studies highlighted for S100B a sensitivity and a negative predictive value, for intracranial lesions, both of 100%. Implementation of a modified PECARN (Pediatric Emergency Care Applied Research Network) rule, which includes measurement of S100B protein, reduced by 70% the number of diagnostic imaging investigations needed to identify mTBI in a pediatric population.
Recently the Scandinavian Neurotrauma Committee (SNC) recommended serum S100B dosing as a biomarker for low-risk mild traumatic brain injury. Based on this evidence and considerations, we believe it is of primary importance to carry out a study aimed at the future implementation, also in our hospital, of the S100B dosage.
The study mainly aims at:
- registering the fluctuations in the quantification of the S100B protein in cases of mTBI
- characterizing the sensitivity and the negative predictive value of the test for an efficient stratification of the prognosis of different entities of head trauma
The dosage of S100B at the OSR will be carried out via the COBAS8000 (Roche) large automation line, already present in OSR. The reagents are commercially available. This will allow to obtain results in a very short time (within minutes) and at very low costs.
Secondly, the study aims to store the biological samples (serum) at the OSR Biological Resources Center. The samples will be used later to evaluate the diagnostic potential of novel blood markers of brain damage that have recently emerged in the literature and could, in the future, be part together with S100B of a highly sensitive analytical panel. These biomarkers are; the glial fibrillary acidic protein (G-FAP), the ubiquitin c-terminal hydrolase L1 (UCH-L1) and the neurofilament light (NfL).
As for S100B, the dosage of G-FAP, UCH-L1 and NfL will be carried out at OSR, using the COBAS8000 large automation line (Roche).
- Conditions
- Head Trauma
- Medical subject headings
- Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects admitted at the ED with head trauma, regardless of age or gender | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Blood sampling at day 0 (at ED admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Sep 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head TraumaStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Locatelli, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036146
- Sponsor's protocol ID
- SMART
- Status last verified
- Sep 2025
- First submitted
- 17 Jun 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be analyzed at the IRCCS San Raffaele Hospital with no need to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Transversal Observational Study on the Evaluation of S100B Changes in Subjects Attending the Emergency Department With Head Trauma
- ClinicalTrials.gov ID
- NCT07036146
- Acronym / sponsor ID
- SMART
- Conditions
- Head Trauma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Traumatic brain injury (TBI) is a leading cause of death and hospital admissions worldwide, with over 50 million new cases occurring globally annually. Based on the severity, brain traumas have been classified in four different categories: Minimal, Mild, Moderate and Severe TBI. Mild and Moderate TBI (mTBI), represents the vast majority of TBIs occurring in the ED. Imaging techniques, such as computed tomography (CT), are traditionally the most widely used diagnostic method in evaluating a patient with suspected mTBI. However, only approximately 16% of patients attending the ED with suspected mTBI present intracranial lesions (proved with imaging techniques). Furthermore, the diagnostic process based on imaging techniques involves an average stay in the ED of approximately 7 hours. Despite the low diagnostic yield, the high cost and the potential side effect of the ionizing radiation, the use of imaging techniques is supported on the basis that even a mTBI can hide a serious, life-threatening injury.
In this context, the beta subunit of the calcium binding protein S100B has emerged as a highly diagnostic biomarker in the management of TBI, and in particular for mTBI, if the measurement is performed within the first hours of trauma. S100B can be detected with a simple and rapid routine venous blood test, making its use minimally invasive for the patient and extremely more efficient (both in terms of costs and time) for the hospital. Thanks to a sensitivity of 97% associated with a negative predictive value >99%, the S100B dosage can predict the absence of brain damage, facilitating risk stratification and safe discharge of low-risk patients allowing the reduction of the number of imaging tests, and consequently the patient's length of stay in the ED.
The S100B dosage is therefore an objective tool for patient triage. It is simpler and faster to perform than imaging techniques and involves reduced treatment costs which can be estimated at approximately 100 euros per patient.
The implementation of the S100B dosage in a clinical/diagnostic routine becomes even more important in pediatric settings. It has been shown that exposure to ionizing radiation at a young age (0-19 years) can increase the risk of cancer by up to 24%. In this context, S100B has proven to be a very promising biomarker for children with mTBI. A meta-analysis of eight studies highlighted for S100B a sensitivity and a negative predictive value, for intracranial lesions, both of 100%. Implementation of a modified PECARN (Pediatric Emergency Care Applied Research Network) rule, which includes measurement of S100B protein, reduced by 70% the number of diagnostic imaging investigations needed to identify mTBI in a pediatric population.
Recently the Scandinavian Neurotrauma Committee (SNC) recommended serum S100B dosing as a biomarker for low-risk mild traumatic brain injury. Based on this evidence and considerations, we believe it is of primary importance to carry out a study aimed at the future implementation, also in our hospital, of the S100B dosage.
The study mainly aims at:
- registering the fluctuations in the quantification of the S100B protein in cases of mTBI
- characterizing the sensitivity and the negative predictive value of the test for an efficient stratification of the prognosis of different entities of head trauma
The dosage of S100B at the OSR will be carried out via the COBAS8000 (Roche) large automation line, already present in OSR. The reagents are commercially available. This will allow to obtain results in a very short time (within minutes) and at very low costs.
Secondly, the study aims to store the biological samples (serum) at the OSR Biological Resources Center. The samples will be used later to evaluate the diagnostic potential of novel blood markers of brain damage that have recently emerged in the literature and could, in the future, be part together with S100B of a highly sensitive analytical panel. These biomarkers are; the glial fibrillary acidic protein (G-FAP), the ubiquitin c-terminal hydrolase L1 (UCH-L1) and the neurofilament light (NfL).
As for S100B, the dosage of G-FAP, UCH-L1 and NfL will be carried out at OSR, using the COBAS8000 large automation line (Roche).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects admitted at the ED with head trauma, regardless of age or gender | – | – |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- unconscious patients as well as patients for whom the head trauma occurred at least 6 hours before presenting to the emergency room
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: Blood sampling at day 0 (at ED admission)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No. Data will be analyzed at the IRCCS San Raffaele Hospital with no need to share individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head Trauma, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eleonora Sabetta, Doctor (+39 0226435288, sabetta.eleonora@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Blood sampling at day 0 (at ED admission)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.