Rapid Diagnosis and Prognosis Recognition of Imaging and Biomarkers in Mild to Moderate Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- The concentration of serum biomarkers.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
The concentration of serum biomarkers.
时间窗: 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.
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- Change from baseline brain structure measures at 3 months(baseline (early injury), post-traumatic for 3 months.)
- Change from baseline brain structure measures at 12 months(baseline (early injury), post-traumatic for 12 months.)
- Change from baseline brain structure measures at 6 months(baseline (early injury), post-traumatic for 6 months.)
- White matter integrity at baseline (early injury), post-traumatic for 3 months,6 months, and 12 months.(baseline (early injury), post-traumatic for 3 months,6 months, and 12 months.)