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

• ClinicalTrials.gov Identifier: NCT04641767
• Recruitment Status: Recruiting
• First Posted: November 24, 2020
• Last Update Posted: January 12, 2021
• Sponsor: Hospital Universitario Virgen Macarena
• Collaborators: Hospitales Universitarios Virgen del Rocío; Germans Trias i Pujol Hospital; Hospital Sant Joan de Deu; Hospital Universitario La Paz; Hospital Infantil Universitario Niño Jesús, Madrid, Spain; Hospital Clinic of Barcelona; Complejo Hospitalario La Mancha Centro; Hospital Son Espases; Hospital Universitario Miguel Servet
• Information provided by (Responsible Party): Joan Montaner Villalonga, Hospital Universitario Virgen Macarena

Study Description

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.

Condition or disease
Mild Traumatic Brain Injury; Moderate Traumatic Brain Injury

Study Design

• Study Type: Observational
• Estimated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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."
• Actual Study Start Date: October 28, 2020
• Estimated Primary Completion Date: February 28, 2022
• Estimated Study Completion Date: December 31, 2022

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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:

• Dementia or other pre-existing neurological condition that makes evaluation difficult
• Recent history (<1 month) of TBI
• Refusal to participate in the study
• Evidence of alcohol or other substance intoxication
• Previous stroke
• Previous severe TBI
• Epilepsy
• Schizophrenia
• Neurodegenerative disease

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:

• Dementia or other pre-existing neurological condition that makes evaluation difficult
• Recent history (<1 month) of TBI
• Refusal to participate in the study
• Evidence of alcohol or other substance intoxication
• Previous stroke
• Previous severe TBI
• Epilepsy
• Schizophrenia
• Neurodegenerative disease

Contacts and Locations

Contacts

Contact: Elvira Chocano, MSc; +34 93 4893000 ext 4941; elvira.chocano@vhir.org

Contact: Luis Sempere, PhD; +34 955 012 638; lluissemperebordes@gmail.com

Locations

Spain

Hospital Germans Trias i Pujol; Recruiting

Badalona, Barcelona, Spain, 08916

Principal Investigator: Roser García, MD

Sub-Investigator: Belén Menéndez, MD

Principal Investigator: María Méndez, MD

Hospital Sant Joan Deu Barcelona; Recruiting

Esplugues De Llobregat, Barcelona, Spain, 08950

Principal Investigator: Carles Luaces, MD

Sub-Investigator: Victoria Trenchs, MD

Complejo Hospitalario La Mancha Centro; Recruiting

Alcázar De San Juan, Ciudad Real, Spain, 13600

Principal Investigator: Ángel Luis Laguna, MD

Hospital Universitario Son Espases; Recruiting

Palma De Mallorca, Mallorca, Spain, 07120

Principal Investigator: Elena Miravet, MD

Hospital Virgen del Rocio; Recruiting

Sevilla, Seville, Spain, 41013

Contact: Luis Sempere, PhD +34 955 012 638 lluissemperebordes@gmail.com

Principal Investigator: María Jesús Sánchez, MD

Principal Investigator: Ana Díez, MD

Hospital Clinic Barcelona; Recruiting

Barcelona, Spain, 08036

Principal Investigator: Arrate Placer, MD

Hospital Infantil Niño Jesus; Recruiting

Madrid, Spain, 28009

Principal Investigator: José Antonio Alonso, MD

Hospital Universitario La Paz; Recruiting

Madrid, Spain, 28046

Principal Investigator: Manuel Quintana, MD

Sub-Investigator: Nataly Cancelliere, MD

Hospital Virgen Macarena; Recruiting

Sevilla, Spain, 41009

Principal Investigator: Paula de la Torre, MD

Principal Investigator: Carmen Navarro, MD

Hospital Universitario Miguel Servet; Recruiting

Zaragoza, Spain, 50009

Principal Investigator: Carmen Campos, MD

Sponsors and Collaborators

Hospital Universitario Virgen Macarena

Hospitales Universitarios Virgen del Rocío

Germans Trias i Pujol Hospital

Hospital Sant Joan de Deu

Hospital Universitario La Paz

Hospital Infantil Universitario Niño Jesús, Madrid, Spain

Hospital Clinic of Barcelona

Complejo Hospitalario La Mancha Centro

Hospital Son Espases

Hospital Universitario Miguel Servet

More Information

Additional Information:

Biotrabis study website 

• Responsible Party: Joan Montaner Villalonga, Joan Montaner, MD, PhD, Hospital Universitario Virgen Macarena
• ClinicalTrials.gov Identifier: NCT04641767
• Other Study ID Numbers: BIOTRABIS_FMM-AP171562019
• First Posted: November 24, 2020
• Last Update Posted: January 12, 2021
• Last Verified: January 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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