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
200 participants
OBSERVATIONAL
2020-10-28
2022-02-21
Brief Summary
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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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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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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.
No interventions assigned to this group
BIOTRABIS>18 - Control patients
Group that includes adult control patients. Those with very mild TBI will be recruited (GCS: 15) without symptoms
No interventions assigned to this group
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).
No interventions assigned to this group
BIOTRABIS<18 - Control patients
Group that includes paediatric control patients. Those with very mild TBI will be recruited (GCS: 15) without symptoms
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Mild TBI patients the first 24 hours after trauma with GCS of 14-15 points.
* Presence of any of the following symptoms:
* Loss of consciousness less than 30 minutes, the first 20 minutes after trauma
* Post-traumatic amnesia less than 24 hours, the first 30 minutes after trauma:
* Persistent headache
* Nausea / vomiting
* Vertigo / dizziness
* Confusion / disorientation
* 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:
* Loss of consciousness less than 30 minutes, the first 20 minutes after trauma
* Post-traumatic amnesia less than 24 hours, the first 30 minutes after trauma:
* Persistent headache
* Nausea / vomiting
* Vertigo / dizziness
* Confusion / disorientation
Exclusion Criteria
* Refusal to participate in the study
* Evidence of alcohol or other substance intoxication
* Epilepsy
* Schizophrenia
BIOTRABIS\<18 (paediatric patients)
* Recent history (\<1 month) of TBI
* Refusal to participate in the study
* Evidence of alcohol or other substance intoxication
* Epilepsy
* Schizophrenia
ALL
No
Sponsors
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Hospital Miguel Servet
OTHER
Hospitales Universitarios Virgen del Rocío
OTHER
Germans Trias i Pujol Hospital
OTHER
Hospital Sant Joan de Deu
OTHER
Hospital Universitario La Paz
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 Universitario Virgen Macarena
OTHER
Responsible Party
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Joan Montaner Villalonga
Joan Montaner, MD, PhD
Locations
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Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Sant Joan Deu Barcelona
Esplugues de Llobregat, Barcelona, Spain
Complejo Hospitalario La Mancha Centro
Alcázar de San Juan, Ciudad Real, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Mallorca, Spain
Hospital Virgen del Rocio
Seville, Seville, Spain
Hospital Clinic Barcelona
Barcelona, , Spain
Hospital Infantil Niño Jesus
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Virgen Macarena
Seville, , Spain
Countries
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Other Identifiers
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BIOTRABIS_FMM-AP171562019
Identifier Type: -
Identifier Source: org_study_id
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