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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04641767
Recruitment Status : Recruiting
First Posted : November 24, 2020
Last Update Posted : January 12, 2021
Sponsor:
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

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

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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

Resource links provided by the National Library of Medicine


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



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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04641767


Contacts
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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
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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
Additional Information:
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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    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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