Mild Traumatic Brain InjuryNCT06327776
New Protein Biomarkers and Technology for Improving Diagnosis and Outcome Prediction in Mild TBI
An observational study of Mild Traumatic Brain Injury, run by Hospital Universitario 12 de Octubre at 1 site in Spain.
Trial summary
Mild traumatic brain injury(mTBI) is a common cause of consultation to the emergency rooms worldwide and is the most common form of traumatic brain injury. Though classified as mild, as many as 40% of patients suffering mTBI do not make complete recoveries or present persistent symptoms. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- Serum and saliva biomarkers
- How many people
- 1,000 participants
- Where
- 1 siteSpain
- Study dates
- 4 Mar 2022to 31 Dec 2025
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 1000 participants suffering mild TBI
Who may be able to join
- Mild TBI (GCS 13-15 on admission)
- Blood sample obtained ≤24h after injury
Who cannot join
- GCS 3-12 on admission
- Time of injury unknown
- Time to injury exceeding 24 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
- Subject under judiciary control
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Alfonso Lagares, MD, PhD, +34917792389, alfonso.lagares@salud.madrid.org
About this study
Official title: Nuevos Biomarcadores y Tecnologia Para Una Mejores Reglas de predicción en el Traumatismo craneoncefálico Leve
Mild traumatic brain injury(mTBI) is a common cause of consultation to the emergency rooms worldwide and is the most common form of traumatic brain injury. Though classified as mild, as many as 40% of patients suffering mTBI do not make complete recoveries or present persistent symptoms. The present study is intended to determine long term outcome of patients suffering mTBI and to establish new prognostic models with the use of serum and saliva based biomarkers. For this purpose this study will not exclude patients regarding their comorbidities.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- Serum and saliva biomarkers
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum and saliva biomarkersOther
2x5mL blood samples and saliva samples will be used to determine the performance of different blood based and saliva biomarkers for determining diagnostic management and prognosis in mTBI patients.
| Study group | Role | What they receive |
|---|---|---|
| MILD TBI Diagnostic and long term prognostic study | 1000 patients suffering mild Traumatic Brain Injury Receives: Other: Serum and saliva biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers diagnostic performance
Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of GFAP and UCHL-1, S100B, Osteopontin, SAA1, YKL-40, Copeptin, NSE, C reactive protein, procalcitonin to detect the presence or absence of intracranial lesions on CT scan
Measured: 24 hours after mild TBI
Secondary outcomes (5)
Determination of the potential of the biomarkers in predicting neurological symptoms after TBI
Early and midterm biomarker predictive performance in terms of predicting neurological outcome. Neurological status at 1 week, 3 months, 6 months and 1 year after TBI and Rivermead post concussion questionnaire.
Measured: 1 week, 3 months, 6 months and 1 year
Determination of the potential of the biomarkers in predicting neurological outcome assessed by the Extended Glasgow Outcome Score (GOSE) after TBI
Early, midterm and long term biomarker predictive performance in terms of predicting neurological outcome. Extended Glasgow Outcome Score (GOSE)
Measured: 1 week, 3 months, 6 months and 1 year
Determination of the potential of the biomarkers in predicting quality of life assessed by Qolibri-OS after TBI
Early, midterm and longterm biomarker predictive performance in terms of predicting quality of life after mild TBI assessed by Qolibri-OS
Measured: 1 week, 3 months, 6 months and 1 year
Determination of the potential of the biomarkers in predicting quality of life assessed by EQ-5D-5L after TBI
Mid and longterm biomarker predictive performance in terms of predicting quality of life after mild TBI assessed by EQ-5D-5L
Measured: 3 months, 6 months and 1 year
Determination of the potential of the biomarkers in predicting quality of sleep assessed by the Epworth and Pittsburgh Scales
Mid and longterm biomarker predictive performance in terms of quality of sleep
Measured: 3 months, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start4 Mar 2022
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario 12 de Octubre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327776
- Sponsor's protocol ID
- 21/709
- Status last verified
- Oct 2023
- First submitted
- 18 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nuevos Biomarcadores y Tecnologia Para Una Mejores Reglas de predicción en el Traumatismo craneoncefálico Leve
- ClinicalTrials.gov ID
- NCT06327776
- Acronym / sponsor ID
- 21/709
- Conditions
- Mild Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hospital Universitario 12 de OctubreUniversity, hospital or other
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Mar 2024 (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.
Mild traumatic brain injury(mTBI) is a common cause of consultation to the emergency rooms worldwide and is the most common form of traumatic brain injury. Though classified as mild, as many as 40% of patients suffering mTBI do not make complete recoveries or present persistent symptoms. The present study is intended to determine long term outcome of patients suffering mTBI and to establish new prognostic models with the use of serum and saliva based biomarkers. For this purpose this study will not exclude patients regarding their comorbidities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MILD TBI Diagnostic and long term prognostic study | – | Other: Serum and saliva biomarkers1000 patients suffering mild Traumatic Brain Injury |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1000 participants suffering mild TBI
Key inclusion criteria (2 listed)
- Mild TBI (GCS 13-15 on admission)
- Blood sample obtained ≤24h after injury
Key exclusion criteria (8 listed)
- GCS 3-12 on admission
- Time of injury unknown
- Time to injury exceeding 24 hours
- Primary admission for non-traumatic neurological disorder (e.g., stroke, spontaneous, intracranial hematoma)
- Penetrating head trauma
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 |
|---|---|---|
| Serum and saliva biomarkers2x5mL blood samples and saliva samples will be used to determine the performance of different blood based and saliva biomarkers for determining diagnostic management and prognosis in mTBI patients. | Other | MILD TBI Diagnostic and long term prognostic study |
Primary outcome
Biomarkers diagnostic performance
Time frame: 24 hours after mild TBI
Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of GFAP and UCHL-1, S100B, Osteopontin, SAA1, YKL-40, Copeptin, NSE, C reactive protein, procalcitonin to detect the presence or absence of intracranial lesions on CT scan
5 secondary outcomes
Determination of the potential of the biomarkers in predicting neurological symptoms after TBI
Time frame: 1 week, 3 months, 6 months and 1 year
Determination of the potential of the biomarkers in predicting neurological outcome assessed by the Extended Glasgow Outcome Score (GOSE) after TBI
Time frame: 1 week, 3 months, 6 months and 1 year
Determination of the potential of the biomarkers in predicting quality of life assessed by Qolibri-OS after TBI
Time frame: 1 week, 3 months, 6 months and 1 year
Determination of the potential of the biomarkers in predicting quality of life assessed by EQ-5D-5L after TBI
Time frame: 3 months, 6 months and 1 year
Determination of the potential of the biomarkers in predicting quality of sleep assessed by the Epworth and Pittsburgh Scales
Time frame: 3 months, 6 months and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Individual participant dataSharing planned: No
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.
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, 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 2 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: status not confirmed, as of the sponsor's last update on 25 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alfonso Lagares, MD, PhD (+34917792839, alfonso.lagares@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers diagnostic performance (time frame: 24 hours after mild TBI). 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 25 Mar 2024.