BIOTRABIS
"Fast Heart Fatty Acid Binding Protein (H-FABP) Determination to Rule Out Brain Damage in Mild Traumatic Brain Injury (TBI): the First Multicenter Study Using a Point of Care Device at Trauma and Pediatric Emergency Departments."
Sponsor study identifier
observational
200
1 country
9
Study Start
October 28, 2020
Actual (reported)Primary Completion
February 14, 2022
Actual (reported)Study Completion
February 21, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 21, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 28, 2020
Actual (reported)November 18, 2020
Actual (reported)November 24, 2020
Actual (reported)February 14, 2022
Actual (reported)February 21, 2022
Actual (reported)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
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.
Group that includes adult control patients. Those with very mild TBI will be recruited (GCS: 15) without symptoms
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).
Group that includes paediatric control patients. Those with very mild TBI will be recruited (GCS: 15) without symptoms
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.
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Sant Joan Deu Barcelona
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
200 participants (actual enrollment reported by the registry).
First Submitted
November 18, 2020
First Posted
November 24, 2020
Study Start
October 28, 2020
Actual (reported)Validation of Cognitive Enhancement Techniques for Mild Traumatic Brain Injury
Contact the study team to confirm eligibility.
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Virgen Macarena
Seville, 41009, Spain
Primary Completion
February 14, 2022
Actual (reported)Study Completion
February 21, 2022
Actual (reported)Last Updated
February 22, 2022
Record last verified: 2022-02
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Source: ClinicalTrials.gov.
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