A Multi-center, Prospective Cohort Study on the Diagnostic Value and Prognostic Factors of the RUCAM Scale in Patients With Acute Drug-induced Liver Injury Based on Chronic Liver Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 主要终点
- ALT
研究概览
简要总结
This study is a multi-center, prospective, non-interventional cohort study with an estimated enrollment of 600 patients with acute DILI. According to the inclusion and exclusion criteria, the RUCAM scale and/or expert evaluation, patients with a clinical diagnosis of acute DILI will be included in the study to establish a multi-center, prospective DILI cohort. Depending on the presence or absence of associated chronic liver disease, the patients will be divided into the basic DILI group with chronic liver disease and basic DILI group without chronic liver disease. All enrolled patients should complete at least six months of follow-up.
详细描述
This study is a multi-center, prospective, non-interventional cohort study with an estimated enrollment of 600 patients with acute DILI. According to the inclusion and exclusion criteria, the RUCAM scale and/or expert evaluation, patients with a clinical diagnosis of acute DILI will be included in the study to establish a multi-center, prospective DILI cohort. Depending on the presence or absence of associated chronic liver disease, the patients will be divided into the basic DILI group with chronic liver disease and basic DILI group without chronic liver disease. All enrolled patients should complete at least six months of follow-up.
This research will propose a new or optimized DILI diagnostic scheme based on the analysis of the problems existing in the practice of RUCAM scale, the clinical characteristics and prognosis of DILI, the exploration of biomarkers, and all the comprehensive information of big data from Hepatox platform, and establish a big data-based diagnosis model or auxiliary diagnosis decision system.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No restriction on age and gender.
- •Patients need to meet one of the following biochemical thresholds for acute liver injury recommended by the international consensus:
- •ALT < 5 x ULN
- •ALP < 2 x ULN
- •ALT 3 ULN and TBIL 2 ULN
- •The duration of liver biochemical abnormalities does not exceed 90 days.
- •For the clinical diagnosis of acute drug-induced liver injury, the RUCAM scale ≥ 6 points is required. However, if the RUCAM scale score is 3-5 points, the opinions of 3 experts are needed to confirm the diagnosis of DILI, and the patients can only be enrolled after the experts agree to it.
- •The patient signs the informed consent form after fully understanding the nature of the study, the nature of his/her disease, related treatment methods, and the potential risks associated with participating in the trial.
排除标准
- •Non-drug induced liver injury
- •An inability to complete the visits prescribed by the study
结局指标
主要结局
ALT
时间窗: 6 months
U/L
ALP
时间窗: 6 months
U/L
TBIL
时间窗: 6 months
umol/L
Clinical symptoms and signs
时间窗: 6 months
fatigue, anorexia, abdominal distention, jaundice, nausea, vomiting, gingival bleeding, epistaxis, liver pain, hepatomegaly, splenomegaly, fever, rashes, joint pain, skin itching, etc.
Adverse events
时间窗: 6 months
Adverse events, severity and time
次要结局
未报告次要终点