A Study of Biomarkers of Mild Traumatic BRAIN Injury

NCT04032509 | Completed DMC

• 2 other identifiers: 38RC19.1762019-A01525-52
• Study Type: observational
• Target: 1,501
• Locations: 2 countries
• Sites: 16

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.

Conditions

Mild Traumatic Brain Injury

Outcome Measures

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.

  2 x 5mL blood sample

  12 hours post Traumatic Brain Injury (TBI)

Secondary Outcomes (7)

• 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

Study Arms (1)

Mild TBI

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

Other: 2 x 5 mL blood sample

Interventions

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.

Mild TBI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1600 patients: 1300 patients in France and 300 patients in Spain

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (16)

Centre Hospitalier Annecy Genevois

Annecy, France

Location

CHU Bordeaux

Bordeaux, France

Location

CHU Dijon

Dijon, France

Location

CHU Grenoble Alpes

Grenoble, France

Location

Hopital Edouard HERRIOT - HCL

Lyon, France

Location

Hopital Lyon Sud HCL

Lyon, France

Location

CHU Montpellier

Montpellier, France

Location

CHU Nantes

Nantes, France

Location

CHU Poitiers

Poitiers, France

Location

CHU Toulouse

Toulouse, France

Location

CHU Tours

Tours, France

Location

Hôpital Nord Ouest de Villefranche sur Saône

Villefranche-sur-Saône, France

Location

Hospital de La Princesa

Madrid, Spain

Location

Hospital del Tajo

Madrid, Spain

Location

Hospital Gregorio Maranon

Madrid, Spain

Location

Hospital Universitario de 12 Octubre

Madrid, Spain

Location

Related Publications (2)

• Lagares A, de la Cruz J, Terrisse H, Mejan O, Pavlov V, Vermorel C, Payen JF; of the BRAINI participants and investigators. An automated blood test for glial fibrillary acidic protein (GFAP) and ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) to predict the absence of intracranial lesions on head CT in adult patients with mild traumatic brain injury: BRAINI, a multicentre observational study in Europe. EBioMedicine. 2024 Dec;110:105477. doi: 10.1016/j.ebiom.2024.105477. Epub 2024 Nov 29.

  PMID: 39612652 DERIVED

• 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.

  PMID: 33632753 DERIVED

MeSH Terms

Conditions

Brain Concussion

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 25, 2019
• Study Start: August 10, 2019
• Primary Completion: June 30, 2021
• Study Completion: September 28, 2021
• Last Updated: March 2, 2022

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4); FR (12)