BIOmarkers of TRAumatic Brain Injury Spain (BIOTRABIS)

Andalusian Health Service

Status: Completed

Conditions: Moderate Traumatic Brain Injury; Mild Traumatic Brain Injury

Study type: Observational

Funder types: Other

Identifiers

NCT04641767

BIOTRABIS_FMM-AP171562019

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

200 participants in 4 patient groups

BIOTRABIS>18 - Pathologic patients

Description:

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

Description:

Group that includes adult control patients. Those with very mild TBI will be recruited (GCS: 15) without symptoms

BIOTRABIS<18 - Pathologic patients

Description:

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

Description:

Group that includes paediatric control patients. Those with very mild TBI will be recruited (GCS: 15) without symptoms