BIOmarkers of TRAumatic Brain Injury Spain (BIOTRABIS) (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."

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.

Study Overview

• Status: Completed
• Conditions: Mild Traumatic Brain Injury; Moderate Traumatic Brain Injury

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic Barcelona
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28009
    • Hospital Infantil Niño Jesus
  • Sevilla, Spain, 41009
    • Hospital Virgen Macarena
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Germans Trias i Pujol
    • Esplugues De Llobregat, Barcelona, Spain, 08950
      • Hospital Sant Joan Deu Barcelona
  • Ciudad Real
    • Alcázar De San Juan, Ciudad Real, Spain, 13600
      • Complejo Hospitalario La Mancha Centro
  • Mallorca
    • Palma De Mallorca, Mallorca, Spain, 07120
      • Hospital Universitario Son Espases
  • Seville
    • Sevilla, Seville, Spain, 41013
      • Hospital Virgen Del Rocio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Biotrabis study website

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 28, 2020
• Primary Completion (ACTUAL): February 14, 2022
• Study Completion (ACTUAL): February 21, 2022

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (ACTUAL): November 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: BIOTRABIS_FMM-AP171562019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No