A Study of Biomarkers of Mild Traumatic BRAIN Injury

Completed

• Conditions: Mild Traumatic Brain Injury
• Interventions: Other: 2 x 5 mL blood sample

• Registration Number: NCT04032509
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-15
• Study First Submitted QC: 2019-07-22
• Study First Posted: 2019-07-25
• Study Start: 2019-08-10
• Status Verified: 2020-08
• Primary Completion: 2021-06-30
• Study Completion: 2021-09-28
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1501

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mild TBI	2 x 5 mL blood sample	Mild TBI (GCS 13-15 on admission) within 12 hours after injury

Primary Outcome Measures

Name	Time	Method
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)	2 x 5mL blood sample

Secondary Outcome Measures

Name	Time	Method
Determination the potential of the two biomarkers in predicting neurological outcome	3 month after TBI	Extended Glasgow Outcome Scale (GOSE)
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)	Quality of life after brain injury (QOLIBRI) Questionnaire
Determination of the potential of the two biomarkers in predicting neurological outcome	3 month after TBI	Rivermead Post-concussion symptoms Questionnaire (RPQ)

Trial Locations

Locations (16)

Hopital Lyon Sud HCL; 🇫🇷 Lyon, France

CHU Poitiers; 🇫🇷 Poitiers, France

CHU Toulouse; 🇫🇷 Toulouse, France

CHU Tours; 🇫🇷 Tours, France

Centre Hospitalier Annecy Genevois; 🇫🇷 Annecy, France

CHU Bordeaux; 🇫🇷 Bordeaux, France

CHU Dijon; 🇫🇷 Dijon, France

CHU Grenoble Alpes; 🇫🇷 Grenoble, France

CHU Montpellier; 🇫🇷 Montpellier, France

CHU Nantes; 🇫🇷 Nantes, France

Hospital de La Princesa; 🇪🇸 Madrid, Spain

Hospital del Tajo; 🇪🇸 Madrid, Spain

Hospital Gregorio Maranon; 🇪🇸 Madrid, Spain

Hospital Universitario de 12 Octubre; 🇪🇸 Madrid, Spain

Hopital Edouard HERRIOT - HCL; 🇫🇷 Lyon, France

Hôpital Nord Ouest de Villefranche sur Saône; 🇫🇷 Villefranche-sur-Saône, France