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

• Sponsor: Poitiers University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03780062
• Collaborator: (none)
• Enrollment: 720
• Locations: 4
• Arm: 1
• Anticipated Duration (Months): 49.4
• Patients Per Site: 180
• Patients Per Site Per Month: 3.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Minor Traumatic Brain Injury; Treatment by Antiplatelet	Biological: S100B protein dosing	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 720 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Interest of S100B Protein for Patient Victim of Minor Traumatic Brain Injury and Treated by Antiplatelet
• Actual Study Start Date: Jan 17, 2019
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: S100B protein dosing	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

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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, …)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU of MONTPELLIER	Montpellier		France	34090
2	CHU of NICE	Nice		France	06003
3	La Pité Salpêtrière	Paris		France	75013
4	CHU of POITIERS	Poitiers		France	86021

Sponsors and Collaborators

• Poitiers University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Poitiers University Hospital
• ClinicalTrials.gov Identifier: NCT03780062
• Other Study ID Numbers: PETEChIA
• First Posted: Dec 19, 2018
• Last Update Posted: Aug 19, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Poitiers University Hospital: S100B protein; minor traumatic brain injuries; antiplatelet therapy
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries

Study Results

No Results Posted as of Aug 19, 2022