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| ID | Type | Description | Link |
|---|---|---|---|
| EIT-HEALTH 220325 | Other Grant/Funding Number | European Institute of Innovation and Technology - EU co-fund |
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| Name | Class |
|---|---|
| Technical University of Munich | OTHER |
| University Hospital, Grenoble | OTHER |
| University Hospital, Clermont-Ferrand | OTHER |
| Hospital Vall d'Hebron |
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Mild traumatic brain injury (mTBI) is one of the most frequent emergencies in the elderly population. Despite most mTBI are managed with cranial computed tomography (CT), only 10% of CTs show lesions, determining CT overuse. The use of serum glial fibrillary acidic protein (GFAP) and Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) have shown potential for ruling out the need for cranial CT. However evidence on biomarker use in mild TBI were not based on studies that included aged participants and patients with comorbidities for which biomarker levels could vary. This is why there is a need for a prospective study that assesses the predictive performance of these two biomarkers in the elderly population, both in elderly patients suffering mild TBI and in a reference population, including patients and participants with and without comorbidities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BRAINI2-ELDERLY DIAGNOSTIC & PROGNOSTIC | 2370 patients suffering mild Traumatic brain injury |
| |
| BRAINI2-ELDERLY REFERENCE | 480 non-tbi elderly reference patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GFAP and UCH-L1 | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers diagnostic performance | Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of GFAP and UCHL-1 used separately and in combination to detect the presence or absence of intracranial lesions on CT scan | 12 hours after mild TBI |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the potential of the two biomarkers in predicting neurological symptoms after TBI | Early and midterm biomarker predictive performance in terms of predicting neurological outcome. Neurological status at 1 week and 3 months after TBI and Rivermead post concussion questionnaire. | 1 week and 3 months |
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Inclusion Criteria:
BRAINI2-ELDERLY DIAGNOSTIC & PROGNOSTIC:
BRAINI2-ELDERLY REFERENCE:
Exclusion Criteria:
BRAINI2-ELDERLY DIAGNOSTIC & PROGNOSTIC:
BRAINI2-ELDERLY REFERENCE:
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2370 participants suffering mild TBI; 480 non TBI participants.
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| Name | Affiliation | Role |
|---|---|---|
| Alfonso Lagares Gómez-Abascal, MD, PhD | Hospital Universitario 12 de Octubre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | France | ||||
| CHU Grenoble-Alpes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37460257 | Derived | 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. |
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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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| OTHER |
| BioMérieux | INDUSTRY |
| EIT Health | OTHER |
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Serum
| GFAP reference values |
GFAP serum level distribution in the non-TBI reference population, considering age and comorbidities. |
| 1 Day, day of extraction of the sample |
| UCHL-1 reference values | UCHL-1 serum level distribution in the non-TBI reference population, considering age and comorbidities. | 1 Day, day of extraction of the sample |
| Determination of the potential of the two biomarkers in predicting neurological outcome assessed by the Extended Glasgow Outcome Score (GOSE) after TBI | Early and midterm biomarker predictive performance in terms of predicting neurological outcome. Extended Glasgow Outcome Score (GOSE) | 1 week and 3 months |
| Determination of the potential of the two biomarkers in predicting quality of life assessed by Qolibri-OS after TBI | Early and midterm biomarker predictive performance in terms of predicting quality of life after mild TBI assessed by Qolibri-OS | 1 week and 3 months |
| Determination of the potential of the two biomarkers in predicting quality of life assessed by EQ-5D-5L after TBI | Midterm biomarker predictive performance in terms of predicting quality of life after mild TBI assessed by EQ-5D-5L | 3 months |
| Determination of the potential of the two biomarkers in depression symptoms assessed by PHQ-9 after TBI | Midterm biomarker predictive performance in terms of predicting depression symptoms after mild TBI assessed by PHQ-9 | 3 months |
| 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 | 28041 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |