Development and Validation of a Risk Prediction Model for Severe Autoimmune Encephalitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- CASE
研究概览
简要总结
A prospective study aims to establish a multicenter clinical diagnosis and treatment database for patients with autoimmune encephalitis (AE). The study will analyze the characteristics of disease progression, changes in immune-inflammatory markers, immunotherapy regimens, and patient outcomes. It seeks to identify clinical indicators for the early recognition of severe AE patients, develop and validate a predictive model for severe AE, and explore effective treatment strategies to rapidly control disease progression during the acute phase of severe AE.
详细描述
To develop and validate a predictive model for severe autoimmune encephalitis (AE), a prospective multicenter study will be conducted. Clinical data of hospitalized AE patients will be collected consecutively, and a multicenter integrated database will be established. This database will include information on the characteristics of disease progression, changes in blood and cerebrospinal fluid immune-inflammatory markers, specific immunotherapy regimens, patient outcomes, and long-term prognoses. The study will analyze the clinical and immunological characteristics of AE patients, identify clinical indicators for early recognition of severe AE, and develop and validate a predictive model for severe AE. Additionally, the study will evaluate the efficacy of early plasma exchange/plasma adsorption therapy and targeted immunotherapy on AE outcomes and long-term prognosis, aiming to explore effective treatment strategies for rapidly controlling disease progression in the acute phase of severe AE.
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
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 14-80 years
- •no restriction on gender
- •meets the diagnostic criteria for confirmed AE, with a clearly identified pathogenic antibody
- •within 3 months of AE
- •patients voluntarily sign the informed consent form; if unable to express their will or sign, the consent form can be signed by a close relative on their behalf
排除标准
- •no lumbar puncture performed for CSF antibody testing
- •did not receive immunotherapy
- •pre-onset modified Rankin Scale (mRS) score ≥3
结局指标
主要结局
CASE
时间窗: 2 months of enrollment
The unabbreviated scale title is the clinical assessment scale for autoimmune encephalitis. The CASE includes a total score of 0-27.The higher the score, the worse the prognosis.
次要结局
- CASE(1 month of enrollment)
- mRS(1 months, 2 months of enrollment)
- GCS(1 months, 2 months of enrollment)
- Prognostic scores (CASE)(6 months, 12 months of enrollment)
- Prognostic scores (mRS)(6 months, 12 months of enrollment)