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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A01525-52 | Other Identifier | ID RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild TBI | Mild TBI (GCS 13-15 on admission) within 12 hours after injury |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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. | 2 x 5mL blood sample | 12 hours post Traumatic Brain Injury (TBI) |
| Measure | Description | 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 | TCD measures at admission | 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 |
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Inclusion Criteria:
Patients >18 years old (France)
Mild TBI (GCS 13-15 on admission) within 12 hours after injury
Indication of brain CT scan:
Exclusion Criteria:
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1600 patients: 1300 patients in France and 300 patients in Spain
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Annecy Genevois | Annecy | France | ||||
| CHU Bordeaux |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39612652 | Derived | 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. | |
| 33632753 |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Neurological status at 1 week after TBI |
| 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 | Quality of life after brain injury (QOLIBRI) Questionnaire | 7 days after traumatic brain injury (TBI) |
| Determination the potential of the two biomarkers in predicting neurological outcome | Extended Glasgow Outcome Scale (GOSE) | 3 month after TBI |
| Determination of the potential of the two biomarkers in predicting neurological outcome | Quality of life after brain injury (QOLIBRI) Questionnaire) | 3 month after TBI |
| Determination of the potential of the two biomarkers in predicting neurological outcome | EuroQuol 5 dimensions 5 level questionnaire (EQ-5D-5L) | 3 month after TBI |
| Determination of the potential of the two biomarkers in predicting neurological outcome | Rivermead Post-concussion symptoms Questionnaire (RPQ) | 3 month after TBI |
| 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 |
| 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. |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |