Clinical trial NCT04641767: BIOmarkers of TRAumatic Brain Injury Spain (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."
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Traumatic Brain Injury
Moderate Traumatic Brain Injury
Lead sponsor: Hospital Universitario Virgen Macarena
Sponsor class: OTHER
Collaborators: name: Hospitales Universitarios Virgen del Rocío
name: Germans Trias i Pujol Hospital
name: Hospital Sant Joan de Deu
name: Hospital Universitario La Paz
name: Hospital Infantil Universitario Niño Jesús, Madrid, Spain
name: Hospital Clinic of Barcelona
name: Complejo Hospitalario La Mancha Centro
name: Hospital Son Espases
name: Hospital Miguel Servet
First posted: 2020-11-24
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Brain damage diagnostic accuracy
timeFrame: through study completion, an average of 2 years
measure: Brain damage long term diagnostic accuracy
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Esplugues De Llobregat
country: Spain
facility: Hospital Sant Joan Deu Barcelona
state: Barcelona
city: Alcázar De San Juan
country: Spain
facility: Complejo Hospitalario La Mancha Centro
state: Ciudad Real
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Mallorca
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
state: Seville
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Madrid
country: Spain
facility: Hospital Infantil Niño Jesus
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
Study officials:
References: