Brain Injuries, TraumaticNCT06854835
The Value of Combined Detection of Different Blood Biomarkers in the Diagnosis and Treatments of Traumatic Brain Injury
An observational study of Brain Injuries, Traumatic and Biomarkers, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial summary
TBI, as a potential risk factor, causes a 1.5 times higher risk of neurodegenerative disease to up to 30-70% of TBI patients with neurological symptoms. Brain trauma is an important global medical, public health and social problem. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Brain Injuries, Traumatic, Biomarkers
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2025to 31 Jul 2027
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eighty voluntary TBI patients were recruited prospectively in strict accordance with the inclusion and exclusion criteria. Patients with TBI were divided into three groups: mild to moderate and severe according to GCS scores. At the same time, 80 limb fracture control group matched by gender, age and education were recruited.
Who may be able to join
- Age: 18-65 years old
- Time of injury: patients with acute traumatic brain injury within 24h
- Glasgow Coma Scale (Glasgow Coma Scale, GCS) score: 13 to 15 for patients with mild traumatic brain injury, 9 to 12 for moderate traumatic brain injury, and 3 to 8 for patients with severe traumatic brain injury
- No other system damage has occurred
- Admitted to hospital for the first diagnosis after the injury
Who cannot join
- With a history of neurological or psychiatric disorders
- Traumatic brain injury occurred before the injury
- History of alcohol or substance abuse
- Mild brain trauma is a complication of other injuries (systemic trauma, facial trauma, or spinal cord trauma) or other causes (psychological trauma, language impairment)
- Patients without visits, and incomplete data during treatment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
TBI, as a potential risk factor, causes a 1.5 times higher risk of neurodegenerative disease to up to 30-70% of TBI patients with neurological symptoms. Brain trauma is an important global medical, public health and social problem. Early diagnosis and effective treatment can effectively reduce the disability rate of patients and the incidence of neurological sequelae, and has increasingly become the focus of the international scientific research community. Exploring blood-based biomarkers has potential clinical value, which can greatly help clinicians to evaluate patients' conditions and develop reasonable plans, and then improve the clinical management and treatment of patients with craniocerebral trauma. Further research work is needed to be done to identify the most effective and efficient biomarker or combination marker strategies for integration into clinical treatment.
Read the detailed description
Over the entire injury time phase of the TBI, the sampling of blood samples in the study was set within 24 hours, aiming to identify a set of biomarkers with assessment significance early after TBI. 1. The aim of this study was to investigate the correlation of different markers concentrations in blood and prognosis in patients with TBI. 2. Identify a set of biomarkers with assessment significance in the early period after TBI.
This project prospectively recruited 80 volunteer patients with voluntary TBI strictly in accordance with the inclusion and exclusion criteria, and 80 control groups matched by gender, age and education. 1 For patients who met the inclusion criteria, cranial MR and CT scans were performed at day 3 and discharge on admission, and clinical neuropsychological scale evaluation and peripheral whole blood collection were performed within 24 hours before each scan. 2. All fracture controls matched for sex, age, education and hands will complete primary MRI and CT examination, clinical neuropsychological scale evaluation and peripheral whole blood collection.Specific study contents include: 1. TBI patients were divided into mild, moderate and severe groups according to GCS scores, Together with the fracture patients in the control group, Blood and cerebrospinal fluid were collected from patients with TBI (mild: two blood collection after admission and discharge; Moderate and severe levels: admission, day 3, discharge, Take blood for three times and take cerebrospinal fluid once at admission); Blood of fracture patients (at admission) 2. Statistical analysis of clinical data. 3. Biomarker concentration determination: blood: NSE, GFAP, S100B, Tau, MBP (myelin basic protein), NFL; CSF: NSE, GFAP, Tau, NFL blood-brain barrier index (cerebrospinal fluid albumin / serum albumin). Among them, there was no dynamic monitoring, and comparison of blood and CSF markers in different groups. 4. Correlation analysis of blood markers, cerebrospinal fluid markers and the degree of brain injury (Spearman correlation analysis) shows the correlation between biomarkers and early assessment of the degree of TBI. 5. Follow-up was 3M / 6M, according to the GOS score: good prognosis and poor prognosis. 6. The correlation of serum and / or cerebrospinal fluid biomarker levels at admission and at discharge with GOS score (ROC curve).
- Conditions
- Brain Injuries, Traumatic, Biomarkers
- Medical subject headings
- Brain Injuries, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Full Outline of Unresponsiveness, FOUR
The FOUR is an questionnaire which has four main assessments: eye opening, exercise, brain stem reflex, and respiratory function. Each item has a full score of 4 and a total score of 16. Brainstem reflex and respiratory function of FOUR are more sensitive than the GCS language score for predicting mortality risk in ICU patients. The total score was 0 to 16, with lower scores indicating a greater probability of death and disability.
Measured: On admission (within 24 hours), 3 days of admission and at discharge (up to 24 weeks)
Glasgow Outcome Scale-Extended, GOS-E
GOS-E is a clinical assessment tool for assessing function and quality of life in patients with head trauma. This is an expanded version of the Glasgow Rating Scale, designed to provide a more comprehensive assessment to better understand the patient's recovery. The GOS-E scores were divided into the following categories: 1= death, 2= vegetative state, 3= severe disability, 4= moderate to severe disability, 5= moderate disability, 6= mild disability, 7= good recovery, and 8= complete recovery
Measured: On admission (within 24 hours), 3 days of admission and at discharge (up to 24 weeks)
Head MRI
The MRI scan sequence includes the following:
- 3-pl (positioning image requires preservation of the whole brain, including overhead scalp to all cerebellum) (check the parameters before scanning)
- T2-FLAIR (predict brain conditions, if abnormal lesions, stop scanning immediately)
- ESWAN
- T1-weighted 3D-MPRAGE
- DTI
- Resting State (BOLD) (positioning line is parallel to AC-PC line)
- ASL
- Axial-T1
Measured: On admission (within 24 hours), 3 days of admission and at discharge (up to 24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start15 Mar 2025 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854835
- Sponsor's protocol ID
- XJTU1AF2020LSYY-G-269-01
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2025
- Last updated
- 3 Mar 2025
- 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 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Combined Detection of Different Blood Biomarkers in the Diagnosis and Treatments of Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06854835
- Acronym / sponsor ID
- XJTU1AF2020LSYY-G-269-01
- Conditions
- Brain Injuries, Traumatic, Biomarkers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 3 Mar 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.
TBI, as a potential risk factor, causes a 1.5 times higher risk of neurodegenerative disease to up to 30-70% of TBI patients with neurological symptoms. Brain trauma is an important global medical, public health and social problem. Early diagnosis and effective treatment can effectively reduce the disability rate of patients and the incidence of neurological sequelae, and has increasingly become the focus of the international scientific research community. Exploring blood-based biomarkers has potential clinical value, which can greatly help clinicians to evaluate patients' conditions and develop reasonable plans, and then improve the clinical management and treatment of patients with craniocerebral trauma. Further research work is needed to be done to identify the most effective and efficient biomarker or combination marker strategies for integration into clinical treatment.
Detailed description
Over the entire injury time phase of the TBI, the sampling of blood samples in the study was set within 24 hours, aiming to identify a set of biomarkers with assessment significance early after TBI. 1. The aim of this study was to investigate the correlation of different markers concentrations in blood and prognosis in patients with TBI. 2. Identify a set of biomarkers with assessment significance in the early period after TBI.
This project prospectively recruited 80 volunteer patients with voluntary TBI strictly in accordance with the inclusion and exclusion criteria, and 80 control groups matched by gender, age and education. 1 For patients who met the inclusion criteria, cranial MR and CT scans were performed at day 3 and discharge on admission, and clinical neuropsychological scale evaluation and peripheral whole blood collection were performed within 24 hours before each scan. 2. All fracture controls matched for sex, age, education and hands will complete primary MRI and CT examination, clinical neuropsychological scale evaluation and peripheral whole blood collection.Specific study contents include: 1. TBI patients were divided into mild, moderate and severe groups according to GCS scores, Together with the fracture patients in the control group, Blood and cerebrospinal fluid were collected from patients with TBI (mild: two blood collection after admission and discharge; Moderate and severe levels: admission, day 3, discharge, Take blood for three times and take cerebrospinal fluid once at admission); Blood of fracture patients (at admission) 2. Statistical analysis of clinical data. 3. Biomarker concentration determination: blood: NSE, GFAP, S100B, Tau, MBP (myelin basic protein), NFL; CSF: NSE, GFAP, Tau, NFL blood-brain barrier index (cerebrospinal fluid albumin / serum albumin). Among them, there was no dynamic monitoring, and comparison of blood and CSF markers in different groups. 4. Correlation analysis of blood markers, cerebrospinal fluid markers and the degree of brain injury (Spearman correlation analysis) shows the correlation between biomarkers and early assessment of the degree of TBI. 5. Follow-up was 3M / 6M, according to the GOS score: good prognosis and poor prognosis. 6. The correlation of serum and / or cerebrospinal fluid biomarker levels at admission and at discharge with GOS score (ROC curve).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eighty voluntary TBI patients were recruited prospectively in strict accordance with the inclusion and exclusion criteria. Patients with TBI were divided into three groups: mild to moderate and severe according to GCS scores. At the same time, 80 limb fracture control group matched by gender, age and education were recruited.
Key inclusion criteria (5 listed)
- Age: 18-65 years old
- Time of injury: patients with acute traumatic brain injury within 24h
- Glasgow Coma Scale (Glasgow Coma Scale, GCS) score: 13 to 15 for patients with mild traumatic brain injury, 9 to 12 for moderate traumatic brain injury, and 3 to 8 for patients with severe traumatic brain injury
- No other system damage has occurred
- Admitted to hospital for the first diagnosis after the injury
Key exclusion criteria (5 listed)
- With a history of neurological or psychiatric disorders
- Traumatic brain injury occurred before the injury
- History of alcohol or substance abuse
- Mild brain trauma is a complication of other injuries (systemic trauma, facial trauma, or spinal cord trauma) or other causes (psychological trauma, language impairment)
- Patients without visits, and incomplete data during treatment
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
Full Outline of Unresponsiveness, FOUR
Time frame: On admission (within 24 hours), 3 days of admission and at discharge (up to 24 weeks)
The FOUR is an questionnaire which has four main assessments: eye opening, exercise, brain stem reflex, and respiratory function. Each item has a full score of 4 and a total score of 16. Brainstem reflex and respiratory function of FOUR are more sensitive than the GCS language score for predicting mortality risk in ICU patients. The total score was 0 to 16, with lower scores indicating a greater probability of death and disability.
Glasgow Outcome Scale-Extended, GOS-E
Time frame: On admission (within 24 hours), 3 days of admission and at discharge (up to 24 weeks)
GOS-E is a clinical assessment tool for assessing function and quality of life in patients with head trauma. This is an expanded version of the Glasgow Rating Scale, designed to provide a more comprehensive assessment to better understand the patient's recovery. The GOS-E scores were divided into the following categories: 1= death, 2= vegetative state, 3= severe disability, 4= moderate to severe disability, 5= moderate disability, 6= mild disability, 7= good recovery, and 8= complete recovery
Head MRI
Time frame: On admission (within 24 hours), 3 days of admission and at discharge (up to 24 weeks)
The MRI scan sequence includes the following: 1. 3-pl (positioning image requires preservation of the whole brain, including overhead scalp to all cerebellum) (check the parameters before scanning) 2. T2-FLAIR (predict brain conditions, if abnormal lesions, stop scanning immediately) 3. ESWAN 4. T1-weighted 3D-MPRAGE 5. DTI 6. Resting State (BOLD) (positioning line is parallel to AC-PC line) 7. ASL 8. Axial-T1
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 3 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Brain Injuries, Traumatic
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
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
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, Traumatic and Biomarkers, run by First Affiliated Hospital Xi'an Jiaotong University.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Zhuonan Wang (15332359525, wangzhuonan@xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Full Outline of Unresponsiveness, FOUR (time frame: On admission (within 24 hours), 3 days of admission and at discharge (up to 24 weeks)). The study lists 3 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 3 Mar 2025.