BIOmarkers of TRAumatic Brain Injury Spain (BIOTRABIS)

Mild Traumatic Brain Injury Clinical Trial

— BIOTRABIS  

Official title:

"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."

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04641767
• Other study ID #: BIOTRABIS_FMM-AP171562019
• Status: Completed
• Start date: October 28, 2020
• Est. completion date: February 21, 2022

Study information

• Verified date: February 2022
• Source: Hospital Universitario Virgen Macarena
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 21, 2022
• Est. primary completion date: February 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:
• 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:

• Recent history (<1 month) of TBI
• Refusal to participate in the study
• Evidence of alcohol or other substance intoxication
• Epilepsy
• Schizophrenia 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:
• 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:

• Recent history (<1 month) of TBI
• Refusal to participate in the study
• Evidence of alcohol or other substance intoxication
• Epilepsy
• Schizophrenia

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury
• Moderate Traumatic Brain Injury
• Wounds and Injuries

Locations

Country	Name	City	State
Spain	Complejo Hospitalario La Mancha Centro	Alcázar De San Juan	Ciudad Real
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clinic Barcelona	Barcelona
Spain	Hospital Sant Joan Deu Barcelona	Esplugues De Llobregat	Barcelona
Spain	Hospital Infantil Niño Jesus	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Son Espases	Palma De Mallorca	Mallorca
Spain	Hospital Virgen del Rocio	Sevilla	Seville
Spain	Hospital Virgen Macarena	Sevilla

Sponsors (10)

Lead Sponsor	Collaborator
Hospital Universitario Virgen Macarena	Complejo Hospitalario La Mancha Centro, Germans Trias i Pujol Hospital, Hospital Clinic of Barcelona, Hospital Infantil Universitario Niño Jesús, Madrid, Spain, Hospital Miguel Servet, Hospital Sant Joan de Deu, Hospital Son Espases, Hospital Universitario La Paz, Hospitales Universitarios Virgen del Rocío

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Biotrabis study website