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| Name | Class |
|---|---|
| Hospitales Universitarios Virgen del Rocío | OTHER |
| Germans Trias i Pujol Hospital | OTHER |
| Hospital Sant Joan de Deu | OTHER |
| Hospital Universitario La Paz |
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Traumatic brain injury (TBI) is defined as a structural alteration of brain function caused by external causes, where mild traumatic brain injury (mTBI) represents approximately 80% of all TBI, and although its prognosis is relatively good, it represents a significant cost to the system due to the need to perform a cranial computed tomography (CT) scan, a test of high economic value and not without risks such as irradiation, especially important and dangerous in the pediatric age.
The investigators aim to set-up a point of-care (POC) device to validate a biomarker (H-FABP) able to diagnose the presence of brain damage in children and adults with mTBI at trauma and paediatric Emergency Departments using a blood sample, in order to save resources and avoid subjecting patients to a potentially damaging imaging test. But also, to assess whether the incorporation of new biomarkers improves the prediction of brain damage that can be done with H-FABP.
For that, the investigators will recruit a 400 patients' cohort with blood samples using the available POC device for H-FABP biomarker.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIOTRABIS>18 - Pathologic patients | Group that includes adult patients under study. Those with mild TBI will be recruited. In order to determine the severity of the mild TBI, the doctor uses a scale called the Glasgow GCS scale and mild TBI is understood as those with GCS: 14-15. | ||
| BIOTRABIS>18 - Control patients | Group that includes adult control patients. Those with very mild TBI will be recruited (GCS: 15) without symptoms | ||
| BIOTRABIS<18 - Pathologic patients | Group of paediatric patients under study. This will recruit those who come to the emergency department with mild TBI (GCS 14-15) or moderate (GCS 9-13). | ||
| BIOTRABIS<18 - Control patients | Group that includes paediatric control patients. Those with very mild TBI will be recruited (GCS: 15) without symptoms |
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| Measure | Description | Time Frame |
|---|---|---|
| Brain damage diagnostic accuracy | Brain damage diagnostic in mild TBI patients during hospital admission [% brain damage versus % non brain damage] will be determined by clinical and neuroimaging criteria (CT) at emergency departments arrivals and compared with diagnostic accuracy of a blood biomarker based test. | through study completion, an average of 2 years |
| Brain damage long term diagnostic accuracy | Brain damage diagnostic in mild TBI patients after 3 months [% brain damage long term versus % non brain damage long term ] will be determined by Glasgow Outcome Score (GOSe) through telephone call and compared with previous diagnostic accuracy of a blood biomarker based test. | through study completion, an average of 2 years |
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BIOTRABIS>18 (adult patients)
Inclusion Criteria:
Patients over 18 years old
Mild TBI patients the first 24 hours after trauma with GCS of 14-15 points.
Presence of any of the following symptoms:
Exclusion Criteria:
BIOTRABIS<18 (paediatric patients)
Inclusion Criteria:
Patients between 0 and 17 years old.
Mild TBI (GCS 14-15) and moderate TBI (GCS 9-13) patients the first 24 hours after trauma.
Presence of any of the following symptoms:
Exclusion Criteria:
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BIOTRABIS> 18: Group that includes adult patients. Those with mild TBI will be recruited. In order to determine the severity of the TBI, the doctor uses a scale called the Glasgow GCS scale and mild TBI is understood as those with GCS: 14-15.
BIOTRABIS <18: Group of pediatric patients. This will recruit those who come to the emergency department with mild TBI (GCS 14-15) or moderate (GCS 9-13).
Each group is subdivided into pathological patients (those under study) or control patients.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain | ||
| Hospital Sant Joan Deu Barcelona |
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| Label | URL |
|---|---|
| Biotrabis study website | View source |
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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 |
| Hospital Infantil Universitario Niño Jesús, Madrid, Spain | OTHER |
| Hospital Clinic of Barcelona | OTHER |
| Complejo Hospitalario La Mancha Centro | OTHER |
| Hospital Son Espases | OTHER |
| Hospital Miguel Servet | OTHER |
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| Esplugues de Llobregat |
| Barcelona |
| 08950 |
| Spain |
| Complejo Hospitalario La Mancha Centro | Alcázar de San Juan | Ciudad Real | 13600 | Spain |
| Hospital Universitario Son Espases | Palma de Mallorca | Mallorca | 07120 | Spain |
| Hospital Virgen del Rocio | Seville | Seville | 41013 | Spain |
| Hospital Clinic Barcelona | Barcelona | 08036 | Spain |
| Hospital Infantil Niño Jesus | Madrid | 28009 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Virgen Macarena | Seville | 41009 | Spain |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |