Clinical trial NCT04032509: A Study of Biomarkers of Mild Traumatic BRAIN Injury
Official title: A Prospective Clinical Study of Biomarkers of Mild Traumatic BRAIN Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Traumatic Brain Injury
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2019-07-25
Enrollment: 1501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1600 patients: 1300 patients in France and 300 patients in Spain

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 12 hours post Traumatic Brain Injury (TBI)
Secondary outcomes:
measure: 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
timeFrame: Admission
measure: 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
timeFrame: 7 days after traumatic brain injury (TBI)
measure: 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
timeFrame: 7 days after traumatic brain injury (TBI)
measure: Determination the potential of the two biomarkers in predicting neurological outcome
timeFrame: 3 month after TBI
measure: Determination of the potential of the two biomarkers in predicting neurological outcome
timeFrame: 3 month after TBI
measure: Determination of the potential of the two biomarkers in predicting neurological outcome
timeFrame: 3 month after TBI
measure: Determination of the potential of the two biomarkers in predicting neurological outcome
timeFrame: 3 month after TBI
Other outcomes:
Locations:
city: Annecy
country: France
facility: Centre Hospitalier Annecy Genevois
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Dijon
country: France
facility: CHU Dijon
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Lyon
country: France
facility: Hopital Edouard HERRIOT - HCL
city: Lyon
country: France
facility: Hopital Lyon Sud HCL
city: Montpellier
country: France
facility: CHU Montpellier
city: Nantes
country: France
facility: CHU Nantes
city: Poitiers
country: France
facility: CHU Poitiers
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHU Tours
city: Villefranche-sur-Saône
country: France
facility: Hôpital Nord Ouest de Villefranche sur Saône
city: Madrid
country: Spain
facility: Hospital de La Princesa
city: Madrid
country: Spain
facility: Hospital del Tajo
city: Madrid
country: Spain
facility: Hospital Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario de 12 Octubre
Study officials:
References:
citation: Richard M, Lagares A, Bondanese V, de la Cruz J, Mejan O, Pavlov V, Payen JF; BRAINI investigators. Study protocol for investigating the performance of an automated blood test measuring GFAP and UCH-L1 in a prospective observational cohort of patients with mild traumatic brain injury: European BRAINI study. BMJ Open. 2021 Feb 25;11(2):e043635. doi: 10.1136/bmjopen-2020-043635.