BIOmarkers of TRAumatic Brain Injury Spain (BIOTRABIS)

NCT04641767 | Completed

• 1 other identifier: BIOTRABIS_FMM-AP171562019
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Mild Traumatic Brain Injury; Moderate Traumatic Brain Injury

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

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

Study Sites (9)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Sant Joan Deu Barcelona

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Complejo Hospitalario La Mancha Centro

Alcázar de San Juan, Ciudad Real, 13600, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, Mallorca, 07120, Spain

Location

Hospital Virgen del Rocio

Seville, Seville, 41013, Spain

Location

Hospital Clinic Barcelona

Barcelona, 08036, Spain

Location

Hospital Infantil Niño Jesus

Madrid, 28009, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Virgen Macarena

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Joan Montaner, MD, PhD

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 24, 2020
• Study Start: October 28, 2020
• Primary Completion: February 14, 2022
• Study Completion: February 21, 2022
• Last Updated: February 22, 2022

Record last verified: 2022-02

Locations

ES (9)