A Prospective Clinical Study of Biomarkers of Mild Traumatic BRAIN Injury

A Study of Biomarkers of Mild Traumatic BRAIN Injury

Sponsors

Lead sponsor: University Hospital, Grenoble

Source University Hospital, Grenoble
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.

Overall Status Recruiting
Start Date August 10, 2019
Completion Date February 28, 2021
Primary Completion Date November 30, 2020
Study Type Observational
Primary Outcome
Measure Time Frame
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. 12 hours post Traumatic Brain Injury (TBI)
Secondary Outcome
Measure Time Frame
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 Admission
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 7 days after traumatic brain injury (TBI)
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 7 days after traumatic brain injury (TBI)
Determination the potential of the two biomarkers in predicting neurological outcome 3 month after TBI
Determination of the potential of the two biomarkers in predicting neurological outcome 3 month after TBI
Determination of the potential of the two biomarkers in predicting neurological outcome 3 month after TBI
Determination of the potential of the two biomarkers in predicting neurological outcome 3 month after TBI
Enrollment 1600
Condition
Intervention

Intervention type: Other

Intervention name: 2 x 5 mL blood sample

Description: 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.

Arm group label: Mild TBI

Eligibility

Sampling method: Probability Sample

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Contact

Last name: Jean françois PAYEN, Pr

Phone: 04 76 76 92 88

Email: [email protected]

Location
facility status contact investigator
CHU Bordeaux | Bordeaux, France Not yet recruiting Cédric GIL JARDINE, Dr [email protected] Cédric GIL JARDINE, Dr Principal Investigator
CHU Dijon | Dijon, France Not yet recruiting Patrick RAY, Pr [email protected] Patrick RAY, Pr Principal Investigator
CHU Grenoble Alpes | Grenoble, France Recruiting Maxime MAIGNAN, Dr 04 76 76 93 93 [email protected] Maxime MAIGNAN, Dr Principal Investigator
Hopital Edouard HERRIOT - HCL | Lyon, France Recruiting Laurent JACQUIN, Dr [email protected] Laurent JACQUIN, Dr Principal Investigator
Hopital Lyon Sud HCL | Lyon, France Recruiting Marion DOUPLAT, Dr [email protected] Marion DOUPLAT, DR Principal Investigator
CHU Montpellier | Montpellier, France Recruiting Mustapha SEBBANE, P m[email protected] Mustapha SEBBANE, Pr Principal Investigator
CHU Nantes | Nantes, France Recruiting Emmanuel MONTASSIER, Dr [email protected] Emmanuel MONTASSIER, Dr Principal Investigator
CHU Poitiers | Poitiers, France Recruiting Jérémy GUENEZAN, Dr [email protected] Jérémy GUENEZAN, Dr Principal Investigator
CHU Toulouse | Toulouse, France Not yet recruiting BALEN Frédéric [email protected] BALEN Frédéric, Dr Principal Investigator
CHU Tours | Tours, France Recruiting Said LARIBI, Pr [email protected] Said LARIBI, Pr Principal Investigator
Hospital Universitario de 12 Octubre | Madrid, Spain Recruiting Alfonso LAGARES, Dr [email protected] Alfonso LAGARES, Dr Principal Investigator
Location Countries

France

Spain

Verification Date

February 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Mild TBI

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

Acronym BRAINI
Patient Data No
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov