BIOmarkers of TRAumatic Brain Injury Spain (BIOTRABIS)

Completed

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

• Registration Number: NCT04641767
• Lead Sponsor: Hospital Universitario Virgen Macarena

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-28
• Study First Submitted: 2020-11-18
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-24
• Status Verified: 2022-02
• Primary Completion: 2022-02-14
• Study Completion: 2022-02-21
• Last Update Submitted: 2022-02-21
• Last Update Posted: 2022-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brain damage diagnostic accuracy	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.
Brain damage long term diagnostic accuracy	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.

Trial Locations

Locations (9)

Hospital Virgen del Rocio; 🇪🇸 Sevilla, Seville, Spain

Hospital Universitario Son Espases; 🇪🇸 Palma De Mallorca, Mallorca, Spain

Hospital Infantil Niño Jesus; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Complejo Hospitalario La Mancha Centro; 🇪🇸 Alcázar De San Juan, Ciudad Real, Spain

Hospital Virgen Macarena; 🇪🇸 Sevilla, Spain

Hospital Clinic Barcelona; 🇪🇸 Barcelona, Spain

Hospital Sant Joan Deu Barcelona; 🇪🇸 Esplugues De Llobregat, Barcelona, Spain