A Study of Biomarkers of Mild Traumatic BRAIN Injury (BRAINI)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Mild Traumatic Brain Injury

Treatments: Other: 2 x 5 mL blood sample

Study type: Observational

Funder types: Other

Identifiers

NCT04032509

2019-A01525-52 (Other Identifier)

38RC19.176

Details and patient eligibility

About

Patients with mild traumatic brain injury (mTBI) represent a burden of patients admitted to the emergency department. According to the guidelines, a cerebral CT scan is indicated after mTBI according to the specific conditions. However, variability exists regarding the respect of these CT scan indications, and less than 10% of patients will have visible brain lesions on CT scan. Recently, serum Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) biomarkers have shown ability to differentiate normal and abnormal CT scan findings after mTBI. These encouraging results prompted us to launch a prospective study using automated and quick measurements of GFAP and UCH-L1 biomarkers to validate these findings.

Enrollment: 1,501 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients >18 years old (France)

• Mild TBI (GCS 13-15 on admission) within 12 hours after injury

• Indication of brain CT scan:

  • neurological focal deficit
  • anterograde amnesia
  • Glasgow coma scale score <15 after 2 hours post-TBI
  • suspicion of vault depression fracture
  • fracture of the basal skull
  • persisting nausea, vomiting or headache
  • post-TBI seizures
  • Pre-injury treatment with antithrombotic drugs
  • Loss of consciousness or amnesia with age >65 years, fall >1m or hit pedestrian
  • Other condition requiring CT scan according to the in-charge physician.

Exclusion criteria

• GCS 3-12 on admission
• Time of injury unknown
• Time to injury exceeding 12 hours
• Primary admission for non-traumatic neurological disorder (e.g., stroke, spontaneous intracranial hematoma)
• Penetrating head trauma
• Patient with mechanical ventilation
• Pre-injury neurological disorder affecting the assessment of neurological outcome: dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumor, and history of neurosurgery, stroke or transient ischemic attack (TIA) within the last 30 days
• Venipuncture not feasible
• No realization of brain CT-scan
• Subject under judiciary control
• Pregnant or breastfeeding woman
• Subject in exclusion period of another study

Trial design

1,501 participants in 1 patient group

Mild TBI

Description:

Mild TBI (GCS 13-15 on admission) within 12 hours after injury

Treatment:

Other: 2 x 5 mL blood sample