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
2297 participants
OBSERVATIONAL
2022-03-01
2025-03-30
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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BRAINI2-ELDERLY DIAGNOSTIC & PROGNOSTIC
2370 patients suffering mild Traumatic brain injury
GFAP and UCH-L1
2x5mL blood samples will be used to determine the performance of the automated VIDAS TBI platform in assessing serum concentrations of GFAP and UCH-L1 to rule out the need for a CT-scan after mTBI.
BRAINI2-ELDERLY REFERENCE
480 non-tbi elderly reference patients
GFAP and UCH-L1
2x5mL blood samples will be used to determine the performance of the automated VIDAS TBI 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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GFAP and UCH-L1
2x5mL blood samples will be used to determine the performance of the automated VIDAS TBI 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
* Patients ≥65 years of age
* Mild TBI (GCS 13-15 on admission) with indication of brain CT scan in the 12 hours after injury ;
* Blood sample obtained ≤12 h after injury and CT scan preferably ≤6h from blood sample.
* BRAINI2-ELDERLY REFERENCE:
* Non TBI patients ≥65 years of age
Exclusion Criteria
* Age below 65 years.
* 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 from the trauma scene or prehospital management.
* Venipuncture not feasible
* No realization of brain CT-scan
* Subject under judiciary control
* Subject in inclusion period of a drug interventional study
* BRAINI2-ELDERLY REFERENCE:
* Subject in inclusion period of another drug interventional study
* Patients harboring a brain tumor
* Patients that have had a stroke or neurosurgical operation 1 month prior to the inclusion in the study.
65 Years
ALL
Yes
Sponsors
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Technical University of Munich
OTHER
University Hospital, Grenoble
OTHER
University Hospital, Clermont-Ferrand
OTHER
Hospital Vall d'Hebron
OTHER
BioMérieux
INDUSTRY
EIT Health
OTHER
Hospital Universitario 12 de Octubre
OTHER
Responsible Party
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Alfonso Lagares Gómez-Abascal
Department of Neurosurgery, Head
Principal Investigators
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Alfonso Lagares Gómez-Abascal, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario 12 de Octubre
Locations
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CHU Clermont-Ferrand
Clermont-Ferrand, , France
CHU Grenoble-Alpes
Grenoble, , France
Hôpital Edouard HERRIOT
Lyon, , France
Hôpital Lyon Sud HCL
Lyon, , France
Klinikum rechts der Isar
Munich, , Germany
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Countries
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References
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Lagares A, Payen JF, Biberthaler P, Poca MA, Mejan O, Pavlov V, Viglino D, Sapin V, Lassaletta A, de la Cruz J; Braini2_elderly_investigators Collaborative group. Study protocol for investigating the clinical performance of an automated blood test for glial fibrillary acidic protein and ubiquitin carboxy-terminal hydrolase L1 blood concentrations in elderly patients with mild traumatic BRAIN Injury and reference values (BRAINI-2 Elderly European study): a prospective multicentre observational study. BMJ Open. 2023 Jul 17;13(7):e071467. doi: 10.1136/bmjopen-2022-071467.
Other Identifiers
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EIT-HEALTH 220325
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HU 12Octubre
Identifier Type: -
Identifier Source: org_study_id