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Clinical Trials/NCT03780062
NCT03780062CompletedPhase 3

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

Poitiers University Hospital4 sites in 1 country720 target enrollmentStarted: January 25, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
720
Locations
4
Primary Endpoint
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

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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, …)

Arms & Interventions

S100B protein dosing

Experimental

Intervention: S100B protein dosing (Biological)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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