Mild Traumatic Brain Injury (mTBI)IMPACTS-BRAININCT07311486
Implementation of Biomarker-Based Care for mTBI - IMPACTS-BRAINI Study
An observational study of Mild Traumatic Brain Injury (mTBI), run by Hospital Universitario 12 de Octubre at 1 site in Spain.
Trial summary
This study aims to evaluate the real-world applicability and clinical added value of a new management pathway for patients presenting to the emergency department (ER) with mild traumatic brain injury (mTBI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Traumatic Brain Injury (mTBI)
- What is being tested?
- GFAP and UCH-L1
- How many people
- 1,000 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jul 2025to 1 May 2026
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mild traumatic brain injured patients admitted in the ER less than 12 hours after injury
Who may be able to join
- -All adult patients suffering mild TBI:( Defined by at least criterion a) and d) and one or more of the other criteria)
- The presence of a plausible traumatic mechanism observed/or related by the patient´s recount of the injury event.
- Presence of one or more clinical signs attributable to brain injury: Loss of consciousness immediately following injury, alteration of mental status immediately following the injury, posttraumatic amnesia or any neurological abnormality.
- At least two acute symptoms related to the injury: feeling confused or disoriented, headache, nausea, vomiting, dizziness, vision problems, memory problems, emotional lability or irritability.
- a GCS between 15 and 13, at least 30 minutes after injury.
- Blood sample obtained ≤12 h after injury and ideally before any imaging prescription.
Who cannot join
- · GCS 3-12 on admission
- Age Below 18 years
- Time of injury unknown
- Time to injury exceeding 12 hours
- Primary admission for non-traumatic neurological disorder (e.g., stroke, spontaneous, intracranial hematoma)
- Penetrating head trauma
- Patient with mechanical ventilation from the trauma scene or prehospital management
- Venipuncture not feasible
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Alfonso Lagares, MD, PhD, +349138000 ext. 4590, alfonso.lagares@salud.madrid.org
About this study
Official title: BLOOD BIOMARKERS TO IMPROVE MANAGEMENT OF MILD TRAUMATIC BRAIN INJURY IMPLIMENTACIÓN STUDY
This study aims to evaluate the real-world applicability and clinical added value of a new management pathway for patients presenting to the emergency department (ER) with mild traumatic brain injury (mTBI). The pathway includes the use of the VIDAS® TBI in vitro diagnostic assay, which measures the blood biomarkers GFAP and UCH-L1 within 12 hours of injury to determine whether a CT scan is necessary.
The study seeks to answer two primary questions:
Read more
- Safety and effectiveness: Whether the VIDAS® TBI test can safely and accurately rule out the need for head CT in mTBI patients in routine emergency care.
- Clinical and operational impact: Whether incorporating this test reduces the number of CT scans performed and shortens ER length of stay for patients with mild TBI.
To assess these outcomes, researchers will compare patient management using the new biomarker-based pathway to a historical cohort of mTBI patients who were managed without the biomarker test.
Read the detailed description
GENERAL OBJECTIVE To assess the applicability and added value of a new clinical management pathway for patients with mild TBI presenting to the emergency department (ER), including the use of an in vitro diagnostic assay measuring the biomarkers GFAP and UCH-L1 in the serum, within the first 12 hours post-injury, to rule out the need for CT scan in mild TBI patients.
PRINCIPAL OBJECTIVE To evaluate the diagnostic performance of the VIDAS TBI (GFAP\&UCH-L1) test in determining the need for CT-scan in patients with mild TBI admitted to the ER of Hospital 12 de Octubre.
To determine the safety of a management protocol including the use of the VIDAS GFAP\&UCH-L1 test for patients with mTBI, in terms of complications or unforeseen neurological deterioration following the injury.
To estimate the reduction of CTs achieved using the biomarker test, by comparison with the management of TBI during the six months preceding the study (reference pathway).
METHODOLOGY The study will compare the different outcome measures between a historic group obtained 6 months before the initiation of the new management protocol and the group of patients admitted in the ER with a diagnosis of a mTBI after the initiation of the new bundle of care. Therefore the methodology of the study is an ambispective (or mixed) cohort study with historical controls.
The combined GFAP\&UCH-L1 test has been included in the new bundle of care of mTBI for the management in the ER of all patients with mTBI. In summary the test will be performed to all patients with mTBI admitted to the ER of Hospital 12 de Octubre and included in the new management pathway of patients with mTBI incorporated in our hospital. All patients suffering a mTBI(GCS 15-13) and admitted within 12 hours of the TBI will be included in this pathway. If the patient is included in this pathway, the prescription of cranial CT will be performed following the results of the VIDAS TBI test if the patient has had a significant TBI and a GCS of 14 or 15. Those patients with GCS of 13 or a focal neurological deficit will receive both biomarkers and CT for their management during the study period. The VIDAS TBI test interpretation as defined by the manufacturer, bioMérieux, takes into account the responses of the two biomarkers: the VIDAS TBI test is negative if the two markers GFAP and UCH-L1 are negative (below the previously defined threshold concentration for each of the biomarkers). The test is positive if at least one of the two GFAP or UCH-L1 biomarkers is positive (beyond the threshold concentration). This test is already CE marked and has already been tested on a large number of European patients and has demonstrated good safety and reliability profiles.
STUDY POPULATION Mild TBI patients with significant brain trauma admitted in the ER of Hospital 12 de Octubre
NUMBER OF SUBJECTS The implementation study will last for 6 months. The number of patients that are normally treated for this pathology is around 3000 patients each year. During the 6 months of the study around 1000 patients will at least be triaged for mild TBI EXPECTED IMPACT This study will demonstrate the feasibility of using a bundle of care based on the determination of blood-based brain biomarkers in the management of patients with mTBI, in a real-life setting. It will also determine the time needed for obtaining results of these blood derived biomarkers and if there is reduction in associated cost and CT prescription related to its use related to a historical control cohort.
- Conditions
- Mild Traumatic Brain Injury (mTBI)
- Being tested
- GFAP and UCH-L1
- Keywords
- Biomarker, GFAP, UCH-L1, Implementation
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GFAP and UCH-L1Diagnostic test
Serum test to measure the concentration of GFAP and UCH-L1
| Study group | Role | What they receive |
|---|---|---|
| Pre-implemetation Mild TBI cohort | Mild TBI patients managed before the implementation of the combined GFAP UCH-L1 test | |
| Post-implementation Mild TBI cohort | Prospective Mild TBI patients managed following a clinical pathway including the use of the combined GFAP UCH-L1 diagnostic test in a real world enviroment Receives: Diagnostic Test: GFAP and UCH-L1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of the biomarker test
Sensitivity, specificity and NPV of the combined biomarker test to determine the presence of lesions on CT
Measured: 12 hours after mild TBI
Proportion (%) of CT scan prescribed in the ER over the period of the study for patients with mTBI
Proportion of patients in whom a CT scan has been performed for screening of intracranial lesiones
Measured: 12 hours after mild TBI
Secondary outcomes (2)
Time spent in the ED
Time from admission to discharge. Time from admission to sample obtention. Time from venipuncture to availability of biomarker results.
Measured: 12 hours after mild TBI
Compliance with proposed algorithm
Number of patients in whom a CT scan has been performed despinte negative biomarker test
Measured: 12 hours after mild TBI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start15 Jul 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Traumatic Brain Injury (mTBI)Studies 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
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Hospital Universitario 12 de Octubre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfonso Lagares Gómez-Abascal, Hospital Universitario 12 de Octubre
- Investigators
- Alfonso Lagares, MD, PhD, Principal investigator, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311486
- Sponsor's protocol ID
- TP25/0144
- Acronym
- IMPACTS-BRAINI
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (de-identified) that underlie the results reported in this study will be made available only upon request, after publication of the main results, to researchers who provide a methodologically sound proposal. Data will be shared in accordance with applicable ethical and regulatory requirements, and a data-sharing agreement will be required.
Publications
Lagares A, Maldonado M, Baciu A, Tosi L, Loynaz C, Martinez S, Castano Leon AM, Hernandez-Sanchez J, Garcia Barrio N, de la Cruz J, Sanchez S, Lopez Jimenez A, Cueto-Felgueroso C, Carrasco L, Marquez E, Maria Fernandez Del Pozo A, Amil C, Arias A, Mejan O. Study protocol for investigating real-world implementation of a combined glial fibrillary acidic protein (GFAP) and ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) blood test in the management of adult mild traumatic brain injury in a single-centre European emergency department: the IMPACTS-BRAINI study. BMJ Open. 2026 Jun 18;16(6):e120021. doi: 10.1136/bmjopen-2026-120021.
PubMed 42315262
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BLOOD BIOMARKERS TO IMPROVE MANAGEMENT OF MILD TRAUMATIC BRAIN INJURY IMPLIMENTACIÓN STUDY
- ClinicalTrials.gov ID
- NCT07311486
- Acronym / sponsor ID
- IMPACTS-BRAINI / TP25/0144
- Conditions
- Mild Traumatic Brain Injury (mTBI)
- Keywords
- Biomarker, GFAP, UCH-L1, Implementation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hospital Universitario 12 de OctubreUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 31 Dec 2025 (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.
This study aims to evaluate the real-world applicability and clinical added value of a new management pathway for patients presenting to the emergency department (ER) with mild traumatic brain injury (mTBI). The pathway includes the use of the VIDAS® TBI in vitro diagnostic assay, which measures the blood biomarkers GFAP and UCH-L1 within 12 hours of injury to determine whether a CT scan is necessary.
The study seeks to answer two primary questions:
- Safety and effectiveness: Whether the VIDAS® TBI test can safely and accurately rule out the need for head CT in mTBI patients in routine emergency care.
- Clinical and operational impact: Whether incorporating this test reduces the number of CT scans performed and shortens ER length of stay for patients with mild TBI.
To assess these outcomes, researchers will compare patient management using the new biomarker-based pathway to a historical cohort of mTBI patients who were managed without the biomarker test.
Detailed description
GENERAL OBJECTIVE To assess the applicability and added value of a new clinical management pathway for patients with mild TBI presenting to the emergency department (ER), including the use of an in vitro diagnostic assay measuring the biomarkers GFAP and UCH-L1 in the serum, within the first 12 hours post-injury, to rule out the need for CT scan in mild TBI patients.
PRINCIPAL OBJECTIVE To evaluate the diagnostic performance of the VIDAS TBI (GFAP\&UCH-L1) test in determining the need for CT-scan in patients with mild TBI admitted to the ER of Hospital 12 de Octubre.
To determine the safety of a management protocol including the use of the VIDAS GFAP\&UCH-L1 test for patients with mTBI, in terms of complications or unforeseen neurological deterioration following the injury.
To estimate the reduction of CTs achieved using the biomarker test, by comparison with the management of TBI during the six months preceding the study (reference pathway).
METHODOLOGY The study will compare the different outcome measures between a historic group obtained 6 months before the initiation of the new management protocol and the group of patients admitted in the ER with a diagnosis of a mTBI after the initiation of the new bundle of care. Therefore the methodology of the study is an ambispective (or mixed) cohort study with historical controls.
The combined GFAP\&UCH-L1 test has been included in the new bundle of care of mTBI for the management in the ER of all patients with mTBI. In summary the test will be performed to all patients with mTBI admitted to the ER of Hospital 12 de Octubre and included in the new management pathway of patients with mTBI incorporated in our hospital. All patients suffering a mTBI(GCS 15-13) and admitted within 12 hours of the TBI will be included in this pathway. If the patient is included in this pathway, the prescription of cranial CT will be performed following the results of the VIDAS TBI test if the patient has had a significant TBI and a GCS of 14 or 15. Those patients with GCS of 13 or a focal neurological deficit will receive both biomarkers and CT for their management during the study period. The VIDAS TBI test interpretation as defined by the manufacturer, bioMérieux, takes into account the responses of the two biomarkers: the VIDAS TBI test is negative if the two markers GFAP and UCH-L1 are negative (below the previously defined threshold concentration for each of the biomarkers). The test is positive if at least one of the two GFAP or UCH-L1 biomarkers is positive (beyond the threshold concentration). This test is already CE marked and has already been tested on a large number of European patients and has demonstrated good safety and reliability profiles.
STUDY POPULATION Mild TBI patients with significant brain trauma admitted in the ER of Hospital 12 de Octubre
NUMBER OF SUBJECTS The implementation study will last for 6 months. The number of patients that are normally treated for this pathology is around 3000 patients each year. During the 6 months of the study around 1000 patients will at least be triaged for mild TBI EXPECTED IMPACT This study will demonstrate the feasibility of using a bundle of care based on the determination of blood-based brain biomarkers in the management of patients with mTBI, in a real-life setting. It will also determine the time needed for obtaining results of these blood derived biomarkers and if there is reduction in associated cost and CT prescription related to its use related to a historical control cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-implemetation Mild TBI cohort | – | –Mild TBI patients managed before the implementation of the combined GFAP UCH-L1 test |
| Post-implementation Mild TBI cohort | – | Diagnostic Test: GFAP and UCH-L1Prospective Mild TBI patients managed following a clinical pathway including the use of the combined GFAP UCH-L1 diagnostic test in a real world enviroment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mild traumatic brain injured patients admitted in the ER less than 12 hours after injury
Key inclusion criteria (6 listed)
- -All adult patients suffering mild TBI:( Defined by at least criterion a) and d) and one or more of the other criteria)
- Blood sample obtained ≤12 h after injury and ideally before any imaging prescription.
Key exclusion criteria (8 listed)
- · GCS 3-12 on admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GFAP and UCH-L1Serum test to measure the concentration of GFAP and UCH-L1 | Diagnostic test | Post-implementation Mild TBI cohort |
Primary outcome
Diagnostic performance of the biomarker test
Time frame: 12 hours after mild TBI
Sensitivity, specificity and NPV of the combined biomarker test to determine the presence of lesions on CT
Proportion (%) of CT scan prescribed in the ER over the period of the study for patients with mTBI
Time frame: 12 hours after mild TBI
Proportion of patients in whom a CT scan has been performed for screening of intracranial lesiones
2 secondary outcomes
Time spent in the ED
Time frame: 12 hours after mild TBI
Compliance with proposed algorithm
Time frame: 12 hours after mild TBI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Derived from this study: PubMed 42315262Lagares A, Maldonado M, Baciu A, Tosi L, Loynaz C, Martinez S, Castano Leon AM, Hernandez-Sanchez J, Garcia Barrio N, de la Cruz J, Sanchez S, Lopez Jimenez A, Cueto-Felgueroso C, Carrasco L, Marquez E, Maria Fernandez Del Pozo A, Amil C, Arias A, Mejan O. Study protocol for investigating real-world implementation of a combined glial fibrillary acidic protein (GFAP) and ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) blood test in the management of adult mild traumatic brain injury in a single-centre European emergency department: the IMPACTS-BRAINI study. BMJ Open. 2026 Jun 18;16(6):e120021. doi: 10.1136/bmjopen-2026-120021.
- Individual participant dataSharing planned: Yes. Individual participant data (de-identified) that underlie the results reported in this study will be made available only upon request, after publication of the main results, to researchers who provide a methodologically sound proposal. Data will be shared in accordance with applicable ethical and regulatory requirements, and a data-sharing agreement will be required.
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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.
Alfonso Lagares, MD, PhD principal investigator
Hospital Universitario 12 de Octubre
1 site 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 (mTBI), run by Hospital Universitario 12 de Octubre at 1 site 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alfonso Lagares, MD, PhD (+34913908000 ext. 4590, alfonlag@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of the biomarker test (time frame: 12 hours after mild TBI). 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?
On the ClinicalTrials.gov record for NCT07311486, which also lists 1 linked publication.
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 31 Dec 2025.