A Study of Biomarkers of Mild Traumatic BRAIN Injury

Mild Traumatic Brain Injury Clinical Trial

— BRAINI  

Official title:

A Prospective Clinical Study of Biomarkers of Mild Traumatic BRAIN Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04032509
• Other study ID #: 38RC19.176
• Secondary ID: 2019-A01525-52
• Status: Completed
• Start date: August 10, 2019
• Est. completion date: September 28, 2021

Study information

• Verified date: August 2020
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1501
• Est. completion date: September 28, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• 2 x 5 mL blood sample
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.

Locations

Country	Name	City	State
France	Centre Hospitalier Annecy Genevois	Annecy
France	CHU Bordeaux	Bordeaux
France	CHU Dijon	Dijon
France	CHU Grenoble Alpes	Grenoble
France	Hopital Edouard HERRIOT - HCL	Lyon
France	Hopital Lyon Sud HCL	Lyon
France	CHU Montpellier	Montpellier
France	CHU Nantes	Nantes
France	CHU Poitiers	Poitiers
France	CHU Toulouse	Toulouse
France	CHU Tours	Tours
France	Hôpital Nord Ouest de Villefranche sur Saône	Villefranche-sur-Saône
Spain	Hospital de La Princesa	Madrid
Spain	Hospital del Tajo	Madrid
Spain	Hospital Gregorio Maranon	Madrid
Spain	Hospital Universitario de 12 Octubre	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Countries where clinical trial is conducted

France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 x 5mL blood sample	12 hours post Traumatic Brain Injury (TBI)
Secondary	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	TCD measures at admission	Admission
Secondary	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	Neurological status at 1 week after TBI	7 days after traumatic brain injury (TBI)
Secondary	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	Quality of life after brain injury (QOLIBRI) Questionnaire	7 days after traumatic brain injury (TBI)
Secondary	Determination the potential of the two biomarkers in predicting neurological outcome	Extended Glasgow Outcome Scale (GOSE)	3 month after TBI
Secondary	Determination of the potential of the two biomarkers in predicting neurological outcome	Quality of life after brain injury (QOLIBRI) Questionnaire)	3 month after TBI
Secondary	Determination of the potential of the two biomarkers in predicting neurological outcome	EuroQuol 5 dimensions 5 level questionnaire (EQ-5D-5L)	3 month after TBI
Secondary	Determination of the potential of the two biomarkers in predicting neurological outcome	Rivermead Post-concussion symptoms Questionnaire (RPQ)	3 month after TBI