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NCT Number: NCT04641767

BIOmarkers of TRAumatic Brain Injury Spain (BIOTRABIS)

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.

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Key information

Conditions

Mild Traumatic Brain Injury Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Moderate Traumatic Brain Injury Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Brain damage diagnostic accuracy

    Time frame: through study completion, an average of 2 years

    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.

  2. Brain damage long term diagnostic accuracy

    Time frame: through study completion, an average of 2 years

    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.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Virgen Macarena

Other

Collaborators

  • 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

Registry information

Official study 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."

Acronym: BIOTRABIS

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 24, 2020
Registry last updated
Feb 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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