Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1501 participants
OBSERVATIONAL
2019-08-10
2021-09-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Mild TBI
Mild TBI (GCS 13-15 on admission) within 12 hours after injury
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Locations
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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, , France
Hospital de La Princesa
Madrid, , Spain
Hospital del Tajo
Madrid, , Spain
Hospital Gregorio Maranon
Madrid, , Spain
Hospital Universitario de 12 Octubre
Madrid, , Spain
Countries
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References
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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.
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.
Other Identifiers
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2019-A01525-52
Identifier Type: OTHER
Identifier Source: secondary_id
38RC19.176
Identifier Type: -
Identifier Source: org_study_id
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