Mild Traumatic Brain InjuryBIOTRABISNCT04641767
BIOmarkers of TRAumatic Brain Injury Spain (BIOTRABIS)
An observational study of Mild Traumatic Brain Injury and Moderate Traumatic Brain Injury, run by Hospital Universitario Virgen Macarena at 9 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mild Traumatic Brain Injury, Moderate Traumatic Brain Injury
- How many people
- 200 participants
- Where
- 9 sitesSpain
- Study dates
- 28 Oct 2020to 21 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Show all 18Show fewer
- Nausea / vomiting
- Vertigo / dizziness
- Confusion / disorientation
- 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
Who cannot join
- 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)
Show all 11Show fewer
- Recent history (<1 month) of TBI
- Refusal to participate in the study
- Evidence of alcohol or other substance intoxication
- Epilepsy
- Schizophrenia
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
Complejo Hospitalario La Mancha Centro
Alcázar de San Juan, Ciudad Real, 13600
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Clinic Barcelona
Barcelona, 08036
Hospital Sant Joan Deu Barcelona
Esplugues de Llobregat, Barcelona, 08950
Hospital Infantil Niño Jesus
Madrid, 28009
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Son Espases
Palma de Mallorca, Mallorca, 07120
Hospital Virgen del Rocio
Seville, Seville, 41013
Hospital Virgen Macarena
Seville, 41009
About this study
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."
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.
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain damage diagnostic accuracy
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.
Measured: through study completion, an average of 2 years
Brain damage long term diagnostic accuracy
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.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start28 Oct 2020
- Primary completion14 Feb 2022
- Study completion21 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen Macarena
- Sponsor type
- University, hospital or other
- 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 Miguel Servet
- Responsible party
- Principal investigator, Joan Montaner Villalonga, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641767
- Sponsor's protocol ID
- BIOTRABIS_FMM-AP171562019
- Acronym
- BIOTRABIS
- Status last verified
- Feb 2022
- First submitted
- 18 Nov 2020
- Last updated
- 22 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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."
- ClinicalTrials.gov ID
- NCT04641767
- Acronym / sponsor ID
- BIOTRABIS / BIOTRABIS_FMM-AP171562019
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hospital Universitario Virgen MacarenaUniversity, hospital or other
- 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 Miguel Servet
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 21 Feb 2022 (actual)
- First posted
- 24 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (18 listed)
- 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:
- 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.
Key exclusion criteria (11 listed)
- Recent history (<1 month) of TBI
- Refusal to participate in the study
- Evidence of alcohol or other substance intoxication
- Epilepsy
- Schizophrenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
Related trials for Mild Traumatic Brain Injury
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Recruiting
Virtual Reality in Rehabilitation of Executive Functions in Children With Mild or Moderate Traumatic Brain Injury
Traumatic Brain Injury
Active, not recruiting
Pilot TMS in Mild TBI
Persistent Post Concussive Headache, Mild Traumatic Brain Injury
Recruiting
Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
Mild Traumatic Brain Injury, Post Concussion Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Traumatic Brain Injury and Moderate Traumatic Brain Injury, run by Hospital Universitario Virgen Macarena at 9 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain damage diagnostic accuracy (time frame: through study completion, an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.