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临床试验/NCT03976492
NCT03976492招募中不适用

The Research for New Clinical Diagnostic Strategy of Specific Biomarkers for Traumatic Brain Injury

Baiyun Liu1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2020年12月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
450
试验地点
1
主要终点
Discovery of metabolic biomarkers in plasma that will lead to the early detection of traumatic brain injury

研究概览

简要总结

Traumatic brain injury (TBI) is the most common type of nerve injury and it severely endangers the public health. It is necessary to accurately measure the early neurological function of brain injury for monitoring its prognosis and therapeutic interventions. Glasgow Coma Score (GCS) and Computed Tomography (CT) are often used to diagnose the severity of TBI. However, GCS has its drawbacks in the observation of prognosis, because it is interfered by analgesics, sedatives and relaxants in the evaluation of neurological function. CT may miss the diagnosis of diffuse axonal injury (DAI) and the monitoring of intracranial pressure (ICP). Secondary injuries after TBI, such as oxidative stress, inflammatory damage, and abnormal metabolism, can destroy cerebral blood vessels and structures, which also affect the diagnosis of injury. Therefore, there is an urgent need for new methods to quickly identify which patients are likely to suffer brain injury or even cause persistent disability. Detection of brain injury biomarkers based on blood and brain tissue has long been used to assess the severity of TBI, but no biomarkers have been found for early diagnosis of mTBI and prognosis of different degrees of brain injury. Protein and metabolic product differences were detected from blood or the lesion samples of normal population, patients with traumatic brain injury and/or non-brain injury using mass spectrometry proteomics and metabolomics analysis platform, and diagnostic markers of potential traumatic brain injury were found, and their differential and diagnostic values were discussed.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and Female, aged from 18 to
  • Patients with brain injury within 24 hours after injury
  • Non-brain injury group refers to patients with limb injury or systemic injury except brain injury.
  • The subject reads and fully understands the instructions of the patients and signs the informed consent.

排除标准

  • Male or female, aged below
  • Patients with definite history of central nervous system or cardiovascular system or taking drugs affecting the central nervous system.
  • Patients with severe metabolic diseases.

结局指标

主要结局

Discovery of metabolic biomarkers in plasma that will lead to the early detection of traumatic brain injury

时间窗: One year

Metabolic biomarkers in plasma, such as methionine、glycine、cysteine、gamma-glutamylleucine、5-oxoproline、alpha-ketobutyrate、2-hydroxybutyrate, etal.. assessed by the metabolomics of the one year after traumatic brain injury.

Protein levels of GFAP、UCH-L1、H-FABP、Aβ40、Aβ42、IL-10、NF-L、S100B and tau

时间窗: One year

The difference protein levels of GFAP、UCH-L1、H-FABP、Aβ40、Aβ42、IL-10、NF-L、S100B and tau assessed by the proteomics of the one year after traumatic brain injury.

次要结局

未报告次要终点

研究者

发起方
Baiyun Liu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Baiyun Liu

professor

Beijing Tiantan Hospital

研究点 (1)

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