An observational study in MTBI - Mild Traumatic Brain Injury and Moderate Traumatic Brain Injury, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-04.
Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Observational
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.
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's planned enrollment of 800 is above the median of 100 across 690 observational studies indexed under Brain Injuries.
Browse Brain Injuries studies →First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.
Counted across the registry records on this site, refreshed daily.
TBI patients will be recruited from the emergency department of hospital.
Exclusion Criteria:
patients diagnosed with mild to moderate traumatic brain injury within 1 week after onset of TBI.
Device: MRI, CT, and serum biomarkers
Patients with isolated orthopaedic trauma were identified and enrolled using the same process as that for patients with TBI.
Device: MRI, CT, and serum biomarkers
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.
Device: MRI, CT, and serum biomarkers
magnetic resonance image Imaging data were collected in a strong magnetic field, and collected the serum of participants.
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;
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: baseline (early injury)
Change from baseline brain structure measures at 3 months
The changes of brain volume (mm3) are evaluated by structural MRI
Time frame: 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
Time frame: 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
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.
The white matter integrity are characterized by fractional anisotropy (FA) which calculated by diffusion tensor imaging.
Time frame: baseline (early injury), post-traumatic for 3 months,6 months, and 12 months.
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First Affiliated Hospital Xi'an Jiaotong University