Interest of S100B Protein for Patient Victim of Minor Traumatic Brain Injury and Treated by Antiplatelet

Minor Traumatic Brain Injury Clinical Trial

— PETEChIA  

Official title:

Interest of S100B Protein for Patient Victim of Minor Traumatic Brain Injury and Treated by Antiplatelet

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03780062
• Other study ID #: PETEChIA
• Status: Recruiting
• Phase: Phase 3
• Start date: January 27, 2019
• Est. completion date: January 27, 2026

Study information

• Verified date: January 2024
• Source: Poitiers University Hospital
• Contact: Jérémy GUENEZAN, Hospital Practitioner
• Phone: 0549444444
• Email: jeremy.guenezan[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 720
• Est. completion date: January 27, 2026
• Est. primary completion date: July 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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, …)

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Minor Traumatic Brain Injury
• Treatment by Antiplatelet
• Wounds and Injuries

Intervention

Biological:
• S100B protein dosing
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

Locations

Country	Name	City	State
France	CHU of MONTPELLIER	Montpellier
France	CHU of NICE	Nice
France	La Pité Salpêtrière	Paris
France	CHU of POITIERS	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		3 hours