Back to resultsInterest of S100B Protein for Patient Victim of Minor Traumatic Brain Injury and Treated by Antiplatelet (PETEChIA)
Primary Purpose
Minor Traumatic Brain Injury, Treatment by Antiplatelet
Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
S100B protein dosing
Sponsored by
About this trial
This is an interventional diagnostic trial for Minor Traumatic Brain Injury focused on measuring S100B protein, minor traumatic brain injuries, antiplatelet therapy
Eligibility Criteria
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, …)
Sites / Locations
- CHU of MONTPELLIERRecruiting
- CHU of NICE
- La Pité SalpêtrièreRecruiting
- CHU of POITIERSRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
S100B protein dosing
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03780062
First Posted
December 17, 2018
Last Updated
August 18, 2022
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03780062
Brief Title
Interest of S100B Protein for Patient Victim of Minor Traumatic Brain Injury and Treated by Antiplatelet
Acronym
PETEChIA
Official Title
Interest of S100B Protein for Patient Victim of Minor Traumatic Brain Injury and Treated by Antiplatelet
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2019 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Minor Traumatic Brain Injury, Treatment by Antiplatelet
Keywords
S100B protein, minor traumatic brain injuries, antiplatelet therapy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
720 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
S100B protein dosing
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
S100B protein dosing
Intervention Description
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
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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, …)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jérémy GUENEZAN, Hospital Practitioner
Phone
0549444444
Ext
46991
Email
jeremy.guenezan@chu-poitiers.fr
Facility Information:
Facility Name
CHU of MONTPELLIER
City
Montpellier
ZIP/Postal Code
34090
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mustapha SEBBANE, Professor
Phone
0467336733
Email
m-sebbane@chu-montpellier.fr
Facility Name
CHU of NICE
City
Nice
ZIP/Postal Code
06003
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques LEVRAUT, Professor
Phone
0492033242
Email
levraut.j@chu-nice.fr
Facility Name
La Pité Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Laure PAQUET, Hospital Practitionner
Phone
0142176006
Email
annelaure.paquet@gmail.com
Facility Name
CHU of POITIERS
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérémy GUENEZAN, Hospital Practitionner
Phone
0549444444
Ext
46991
Email
jeremy.guenezan@chu-poitiers.fr
12. IPD Sharing Statement
Learn more about this trial
Interest of S100B Protein for Patient Victim of Minor Traumatic Brain Injury and Treated by Antiplatelet
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