Minor Traumatic Brain InjuryPhase 3PETEChIANCT03780062
Interest of S100B Protein for Patient Victim of Minor Traumatic Brain Injury and Treated by Antiplatelet
A Phase 3 study testing S100B protein dosing in people with Minor Traumatic Brain Injury and Treatment by Antiplatelet, run by Poitiers University Hospital at 4 sites in France.
Trial summary
All the patients admitted in emergency department for minor traumatized cranial, with antiplatelet therapy, can be included, after checked inclusion and non inclusions criterias. If they are agree, a blood sample for the dosage of S100b will be done. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Minor Traumatic Brain Injury, Treatment by Antiplatelet
- What is being tested?
- S100B protein dosing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 4 sitesFrance
- Study dates
- 25 Jan 2019to 28 Oct 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 Years old
- Minor traumatic brain injury measured by a Glasgow score between 13 and 15
- Antiplatelet agent therapy
- Free subject without tutorship or curatorship
Who cannot join
- Age < 18 years old
- Glasgow score <13
- Traumatic brain injury older than 6 hours
- Patient without any social security system
- Patient with renforced protection (tutorship, curatorship, …)
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU of MONTPELLIER
Montpellier, 34090
CHU of NICE
Nice, 06003
La Pité Salpêtrière
Paris, 75013
CHU of POITIERS
Poitiers, 86021
About this study
All the patients admitted in emergency department for minor traumatized cranial, with antiplatelet therapy, can be included, after checked inclusion and non inclusions criterias. If they are agree, a blood sample for the dosage of S100b will be done.
No other modification of the medical care, all patients will have tomodensitometria, according with recommendations. The aim of the study is to validate the negative predictive value of S100b in this population.
- Being tested
- S100B protein dosing
- Keywords
- S100B protein, minor traumatic brain injuries, antiplatelet therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S100B protein dosingBiological
Patients under antiplatelet therapy and who have a minor traumatic brain injury will have a blood samples with protein S100B dosage on arrival to the emergency room and after they will have a brain scanner between 4 and 8 hours after the trauma to analyse the negative predictive value with a treshold of 0.105 μg/L
| Study group | Role | What they receive |
|---|---|---|
| S100B protein dosing | Experimental | Not described Receives: Biological: S100B protein dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain scanner Detection of a cerebral lesion requiring a surgery or medical intervention or an hospitalisation for a patient who have serum level of S100B protein with the treshold of 0.105 μg/L
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start25 Jan 2019
- Primary completion28 Apr 2025
- Study completion28 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minor Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780062
- Sponsor's protocol ID
- PETEChIA
- Acronym
- PETEChIA
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2018
- Last updated
- 29 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of S100B Protein for Patient Victim of Minor Traumatic Brain Injury and Treated by Antiplatelet
- ClinicalTrials.gov ID
- NCT03780062
- Acronym / sponsor ID
- PETEChIA / PETEChIA
- Keywords
- S100B protein, minor traumatic brain injuries, antiplatelet therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 28 Oct 2025 (actual)
- First posted
- 19 Dec 2018 (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.
All the patients admitted in emergency department for minor traumatized cranial, with antiplatelet therapy, can be included, after checked inclusion and non inclusions criterias. If they are agree, a blood sample for the dosage of S100b will be done.
No other modification of the medical care, all patients will have tomodensitometria, according with recommendations. The aim of the study is to validate the negative predictive value of S100b in this population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S100B protein dosing | Experimental | Biological: S100B protein dosing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 Years old
- Minor traumatic brain injury measured by a Glasgow score between 13 and 15
- Antiplatelet agent therapy
- Free subject without tutorship or curatorship
Key exclusion criteria (5 listed)
- Age < 18 years old
- Glasgow score <13
- Traumatic brain injury older than 6 hours
- Patient without any social security system
- Patient with renforced protection (tutorship, curatorship, …)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S100B protein dosingPatients under antiplatelet therapy and who have a minor traumatic brain injury will have a blood samples with protein S100B dosage on arrival to the emergency room and after they will have a brain scanner between 4 and 8 hours after the trauma to analyse the negative predictive value with a treshold of 0.105 μg/L | Biological | S100B protein dosing |
Primary outcome
Brain scanner Detection of a cerebral lesion requiring a surgery or medical intervention or an hospitalisation for a patient who have serum level of S100B protein with the treshold of 0.105 μg/L
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing S100B protein dosing in people with Minor Traumatic Brain Injury and Treatment by Antiplatelet, run by Poitiers University Hospital at 4 sites in France.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain scanner Detection of a cerebral lesion requiring a surgery or medical intervention or an hospitalisation for a patient who have serum level of S100B protein with the treshold of 0.105 μg/L (time frame: 3 hours). 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 29 Dec 2025.