MTBI - Mild Traumatic Brain InjuryNCT05108909
Rapid Diagnosis and Prognosis Recognition of Imaging and Biomarkers in Mild to Moderate Traumatic Brain Injury
An observational study of MTBI - Mild Traumatic Brain Injury and Moderate Traumatic Brain Injury, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
The investigators will carry out multi-center and large sample research based on the Chinese population, screen the optimal diagnostic and prognosis recognition biomarkers and analyze the diagnostic critical cutoff values in patients with mild to moderate traumatic brain injury, so as to provide a substantial basis… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- MTBI - Mild Traumatic Brain Injury, Moderate Traumatic Brain Injury
- What is being tested?
- MRI, CT, and serum biomarkers
- Type of treatment
- Medical device
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 31 Aug 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: TBI patients will be recruited from the emergency department of hospital.
Who may be able to join
- age 18-75 years at time of recruitment.
- Glasgow Coma Scale (GCS) score of 9-15 at the time of informed consent.
- non-penetrating TBI resulting from an external force.
- diagnosed within 1 week after onset of TBI.
- provision of informed written consent.
Who cannot join
- acute suspected stroke, neurosurgery, stroke or TIA within the last 30 days.
- neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumors.
- a history of a previous brain injury, or a history of concurrent substance or alcohol abuse;
- the manifestation of TBI caused by medications, alcohol, drugs for other injuries (such as systemic injuries, facial injuries, or intubation).
- pregnancy or breastfeeding.
- Patients with contraindications to MRI scanning (such as patients with metal implants in their bodies, cardiac pacemakers, dentures, etc.)
- participation in a clinical research study with potential to affect the results of this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
Ming Zhang, phD, 0086-18991232265, zmmri@163.com
Lijun Bai, phD, 0086-15129034948, bailijun@xjtu.edu.cn
About this study
The investigators will carry out multi-center and large sample research based on the Chinese population, screen the optimal diagnostic and prognosis recognition biomarkers and analyze the diagnostic critical cutoff values in patients with mild to moderate traumatic brain injury, so as to provide a substantial basis for clinical diagnosis and prognosis recognition.
Read the detailed description
Traumatic brain injury (TBI) is a complex disorder that comprises a spectrum of intracranial pathologies, many of which present diagnostic challenges. Detection of intracranial injuries after TBI relies on head CT, which is overused and resource intensive. Prior studies have shown the potential for blood-based brain injury biomarkers to predict the absence of intracranial injury after TBI and aid in reducing unnecessary head CT use. Furthermore, plasma biomarker concentrations in the acute phase after TBI identified patients with a suspected TBI and normal head CT who had detectable pathology on MRI. However, most of the current studies are based on the European and American population, and whether the research results are applicable to the Chinese population remains to be studied. Therefore, the investigators will carry out multi-center and large sample research based on the Chinese population, screen the optimal diagnostic and prognosis recognition biomarkers and analyze the diagnostic critical cutoff values, so as to provide a substantial basis for clinical diagnosis and prognosis recognition.
- Being tested
- MRI, CT, and serum biomarkers
- Keywords
- mild to moderate traumatic brain injury, biomarkers, magnetic resonance image, CT, diagnosis, Prognostic identification
- Medical subject headings
- Brain Concussion, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI, CT, and serum biomarkersDevice
magnetic resonance image Imaging data were collected in a strong magnetic field, and collected the serum of participants.
| Study group | Role | What they receive |
|---|---|---|
| mild to moderate traumatic brain injury | patients diagnosed with mild to moderate traumatic brain injury within 1 week after onset of TBI. Receives: Device: MRI, CT, and serum biomarkers | |
| isolated orthopaedic trauma patients | Patients with isolated orthopaedic trauma were identified and enrolled using the same process as that for patients with TBI. Receives: Device: MRI, CT, and serum biomarkers | |
| healthy non-injury control | Healthy non-injured controls were recruited either via a relationship with a TRACK-TBI participant or through public advertisement within TRACK-TBI institutions, and were able to provide informed consent. Receives: Device: MRI, CT, and serum biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
The concentration of serum biomarkers.
the concentration of GFAP with pg/mL, S-100B with pg/mL，IL-6 with pg/mL, IL-8 with pg/mL, IL-10 with pg/mL, IL-1β with pg/mL, TNF-α with pg/mL, UCH-L1 with pg/mL, NSE with pg/mL, T-Tau with pg/mL, P-Tau with pg/mL, NFL with pg/mL, BDNF with pg/mL, and VEGF with pg/mL;
Measured: baseline (early injury), post-traumatic for 3 months, 6 months, and 12 months.
Score of Extended Glasgow Outcome Scale.
The functional outcome of TBI patients. The minimum value is 1, and the maximum value is 8. The higher scores mean a better outcome.
Measured: post-traumatic for 3 months
Score of Extended Glasgow Outcome Scale.
The functional outcome of TBI patients. The minimum value is 1, and the maximum value is 8. The higher scores mean a better outcome.
Measured: post-traumatic for 6 months
Score of Extended Glasgow Outcome Scale.
The functional outcome of TBI patients. The minimum value is 1, and the maximum value is 8. The higher scores mean a better outcome.
Measured: post-traumatic for 12 months
Number of participants with positive head CT scan
CT-positive was defined as the presence of one or more of the following injuries: acute epidural haematoma, acute subdural haematoma, indeterminate extraaxial haemorrhage, intraventricular haemorrhage, parenchymal haematoma, petechial haemorrhagic or bland sheer injury, subarachnoid haemorrhage, brain oedema, brain herniation, non-haemorrhagic contusion, ventricular compression, ventricular trapping, cranial fractures, depressed skull fractures, facial fractures, scalp injury, or skull base fractures.
Measured: baseline (early injury)
Number of participants with MRI abnormalities
MRI abnormalities were quantified according to common data elements standards and definitions by three board-certified neuroradiologists masked to the identity and clinical history of the patient. MRI scans were read as positive if there was evidence of acute intracranial pathology consistent with TBI (eg, contusion, traumatic axonal injury, diffuse axonal injury).
Measured: baseline (early injury)
Secondary outcomes (4)
Change from baseline brain structure measures at 3 months
The changes of brain volume (mm3) are evaluated by structural MRI
Measured: baseline (early injury), post-traumatic for 3 months.
Change from baseline brain structure measures at 6 months
The changes of brain volume (mm3) are evaluated by structural MRI
Measured: baseline (early injury), post-traumatic for 6 months.
Change from baseline brain structure measures at 12 months
The changes of brain volume (mm3) are evaluated by structural MRI
Measured: baseline (early injury), post-traumatic for 12 months.
White matter integrity at baseline (early injury), post-traumatic for 3 months,6 months, and 12 months.
The white matter integrity are characterized by fractional anisotropy (FA) which calculated by diffusion tensor imaging.
Measured: baseline (early injury), post-traumatic for 3 months,6 months, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start1 Sep 2021
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MTBI - Mild Traumatic Brain InjuryStudies 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
- 800 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Xi'an Jiaotong University, Second Affiliated Hospital of Wenzhou Medical University, Central South University, Xijing Hospital
- Responsible party
- Sponsor
- Investigators
- Ming Zhang, phD, Principal investigator, First Affiliated Hospital of Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108909
- Sponsor's protocol ID
- 82071993-2
- Status last verified
- Oct 2021
- First submitted
- 24 Sep 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Diagnosis and Prognosis Recognition of Imaging and Biomarkers in Mild to Moderate Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05108909
- Acronym / sponsor ID
- 82071993-2
- Keywords
- mild to moderate traumatic brain injury, biomarkers, magnetic resonance image, CT, diagnosis, Prognostic identification
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Xi'an Jiaotong University, Second Affiliated Hospital of Wenzhou Medical University, Central South University, Xijing Hospital
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 5 Nov 2021 (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.
The investigators will carry out multi-center and large sample research based on the Chinese population, screen the optimal diagnostic and prognosis recognition biomarkers and analyze the diagnostic critical cutoff values in patients with mild to moderate traumatic brain injury, so as to provide a substantial basis for clinical diagnosis and prognosis recognition.
Detailed description
Traumatic brain injury (TBI) is a complex disorder that comprises a spectrum of intracranial pathologies, many of which present diagnostic challenges. Detection of intracranial injuries after TBI relies on head CT, which is overused and resource intensive. Prior studies have shown the potential for blood-based brain injury biomarkers to predict the absence of intracranial injury after TBI and aid in reducing unnecessary head CT use. Furthermore, plasma biomarker concentrations in the acute phase after TBI identified patients with a suspected TBI and normal head CT who had detectable pathology on MRI. However, most of the current studies are based on the European and American population, and whether the research results are applicable to the Chinese population remains to be studied. Therefore, the investigators will carry out multi-center and large sample research based on the Chinese population, screen the optimal diagnostic and prognosis recognition biomarkers and analyze the diagnostic critical cutoff values, so as to provide a substantial basis for clinical diagnosis and prognosis recognition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mild to moderate traumatic brain injury | – | Device: MRI, CT, and serum biomarkerspatients diagnosed with mild to moderate traumatic brain injury within 1 week after onset of TBI. |
| isolated orthopaedic trauma patients | – | Device: MRI, CT, and serum biomarkersPatients with isolated orthopaedic trauma were identified and enrolled using the same process as that for patients with TBI. |
| healthy non-injury control | – | Device: MRI, CT, and serum biomarkersHealthy non-injured controls were recruited either via a relationship with a TRACK-TBI participant or through public advertisement within TRACK-TBI institutions, and were able to provide informed consent. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- TBI patients will be recruited from the emergency department of hospital.
Key inclusion criteria (5 listed)
- age 18-75 years at time of recruitment.
- Glasgow Coma Scale (GCS) score of 9-15 at the time of informed consent.
- non-penetrating TBI resulting from an external force.
- diagnosed within 1 week after onset of TBI.
- provision of informed written consent.
Key exclusion criteria (7 listed)
- acute suspected stroke, neurosurgery, stroke or TIA within the last 30 days.
- neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumors.
- a history of a previous brain injury, or a history of concurrent substance or alcohol abuse;
- the manifestation of TBI caused by medications, alcohol, drugs for other injuries (such as systemic injuries, facial injuries, or intubation).
- pregnancy or breastfeeding.
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 |
|---|---|---|
| MRI, CT, and serum biomarkersmagnetic resonance image Imaging data were collected in a strong magnetic field, and collected the serum of participants. | Device | healthy non-injury control, isolated orthopaedic trauma patients, mild to moderate traumatic brain injury |
Primary outcome
The concentration of serum biomarkers.
Time frame: baseline (early injury), post-traumatic for 3 months, 6 months, and 12 months.
the concentration of GFAP with pg/mL, S-100B with pg/mL，IL-6 with pg/mL, IL-8 with pg/mL, IL-10 with pg/mL, IL-1β with pg/mL, TNF-α with pg/mL, UCH-L1 with pg/mL, NSE with pg/mL, T-Tau with pg/mL, P-Tau with pg/mL, NFL with pg/mL, BDNF with pg/mL, and VEGF with pg/mL;
Score of Extended Glasgow Outcome Scale.
Time frame: post-traumatic for 3 months
The functional outcome of TBI patients. The minimum value is 1, and the maximum value is 8. The higher scores mean a better outcome.
Score of Extended Glasgow Outcome Scale.
Time frame: post-traumatic for 6 months
The functional outcome of TBI patients. The minimum value is 1, and the maximum value is 8. The higher scores mean a better outcome.
Score of Extended Glasgow Outcome Scale.
Time frame: post-traumatic for 12 months
The functional outcome of TBI patients. The minimum value is 1, and the maximum value is 8. The higher scores mean a better outcome.
Number of participants with positive head CT scan
Time frame: baseline (early injury)
CT-positive was defined as the presence of one or more of the following injuries: acute epidural haematoma, acute subdural haematoma, indeterminate extraaxial haemorrhage, intraventricular haemorrhage, parenchymal haematoma, petechial haemorrhagic or bland sheer injury, subarachnoid haemorrhage, brain oedema, brain herniation, non-haemorrhagic contusion, ventricular compression, ventricular trapping, cranial fractures, depressed skull fractures, facial fractures, scalp injury, or skull base fractures.
Number of participants with MRI abnormalities
Time frame: baseline (early injury)
MRI abnormalities were quantified according to common data elements standards and definitions by three board-certified neuroradiologists masked to the identity and clinical history of the patient. MRI scans were read as positive if there was evidence of acute intracranial pathology consistent with TBI (eg, contusion, traumatic axonal injury, diffuse axonal injury).
4 secondary outcomes
Change from baseline brain structure measures at 3 months
Time frame: baseline (early injury), post-traumatic for 3 months.
Change from baseline brain structure measures at 6 months
Time frame: baseline (early injury), post-traumatic for 6 months.
Change from baseline brain structure measures at 12 months
Time frame: baseline (early injury), post-traumatic for 12 months.
White matter integrity at baseline (early injury), post-traumatic for 3 months,6 months, and 12 months.
Time frame: baseline (early injury), post-traumatic for 3 months,6 months, and 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
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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. This study is not recruiting at the moment.
Ming Zhang, phD principal investigator
First Affiliated Hospital of Xian Jiaotong University
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 MTBI - Mild Traumatic Brain Injury and Moderate Traumatic Brain Injury, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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 7 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 4 Jan 2022. 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 China. 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 Ming Zhang, phD (0086-18991232265, zmmri@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The concentration of serum biomarkers. (time frame: baseline (early injury), post-traumatic for 3 months, 6 months, and 12 months.). The study lists 6 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 4 Jan 2022.