BIOmarkers of TRAumatic Brain Injury Spain (BIOTRABIS)
Spain200 participantsStarted 2020-10-28
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Brain damage diagnostic accuracy
Timeframe: through study completion, an average of 2 years
2
Brain damage long term diagnostic accuracy
Timeframe: through study completion, an average of 2 years