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NCT Number: NCT04032509

A Study of Biomarkers of Mild Traumatic BRAIN Injury

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.

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Key information

Conditions

Mild Traumatic Brain Injury Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Annecy Genevois, Annecy, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2 x 5 mL blood sample

Other

2 x 5 mL blood sample to determine the performance of the automated VIDAS BTI platform in assessing serum concentrations of GFAP and UCH-L1 to rule out the need for a CT-scan after mTBI.

Primary outcomes

  1. Performance of the VIDAS-BTI assay in terms of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and their corresponding lower limit of 95% confidence interval by comparison with brain CT scan findings.

    Time frame: 12 hours post Traumatic Brain Injury (TBI)

    2 x 5mL blood sample

Secondary outcomes

  1. Determination of the added value of the two biomarkers measurements to Transcranial Doppler (TCD) performed on admission to detect patients at risk of neurological worsening and patients allowed for a safe return home

    Time frame: Admission

    TCD measures at admission

  2. Determination of the added value of the two biomarkers measurements to Transcranial Doppler (TCD) performed on admission to detect patients at risk of neurological worsening and patients allowed for a safe return home

    Time frame: 7 days after traumatic brain injury (TBI)

    Neurological status at 1 week after TBI

  3. Determination of the added value of the two biomarkers measurements to Transcranial Doppler (TCD) performed on admission to detect patients at risk of neurological worsening and patients allowed for a safe return home

    Time frame: 7 days after traumatic brain injury (TBI)

    Quality of life after brain injury (QOLIBRI) Questionnaire

  4. Determination the potential of the two biomarkers in predicting neurological outcome

    Time frame: 3 month after TBI

    Extended Glasgow Outcome Scale (GOSE)

  5. Determination of the potential of the two biomarkers in predicting neurological outcome

    Time frame: 3 month after TBI

    Quality of life after brain injury (QOLIBRI) Questionnaire)

  6. Determination of the potential of the two biomarkers in predicting neurological outcome

    Time frame: 3 month after TBI

    EuroQuol 5 dimensions 5 level questionnaire (EQ-5D-5L)

  7. Determination of the potential of the two biomarkers in predicting neurological outcome

    Time frame: 3 month after TBI

    Rivermead Post-concussion symptoms Questionnaire (RPQ)

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

A Prospective Clinical Study of Biomarkers of Mild Traumatic BRAIN Injury

Acronym: BRAINI

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 25, 2019
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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