Evaluation of the Role of Plasma Biomarkers for Portal Hypertension Progression and Oxidative Damage in Decompensation of Cirrhotic Patient.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Identification of predictive biomarkers for the deficit development in patients with compensated cirrhosis.
研究概览
简要总结
This is a single-center and prospective study to identify specific biomarker in order to predict development of decompensation in cirrhotic patients.
The duration of the study is 36 months and it provides a cohort of 200 patients.
详细描述
At screening, patient will have taken blood samples and performed hepatic vein pressure gradient.
After randomization, patient will be seen at follow up every 3 months to do blood sample and every 12 months to undergo hepatic vein pressure gradient , according to the guidelines.
In addition, metabolomics analysis will be performed at screening and every 3 months. The results will be analyzed in relation to emergence of decompensation during follow up period, in order to identify specific metabolomics characteristics that may be able to predict decompensation.
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
- 否
入选标准
- •Diagnosis of liver cirrhosis
- •Aged between 18 and 75 years
- •Obtaining written informed consent
- •Absence of exclusion criteria
排除标准
- •Diagnosis of hepatocellular carcinoma
- •Presence of portal vein thrombosis
- •Liver transplantation
结局指标
主要结局
Identification of predictive biomarkers for the deficit development in patients with compensated cirrhosis.
时间窗: December 2018
Patients will be subject to blood sample periodically and following exams will be made: * Chemistry and hematology to define liver function * Intestinal Fatty Acid Binding Protein * 16S, ribosomal deoxyribonucleic acid * Cluster of differentiation 14 * Interleukin 6 * Asymmetrical dimethylarginine * Tissue factor According to current guidelines, patients will be submitted to: * Hepatic vein pressure gradient AND combined right heart catheterization * Liver elastography
次要结局
- Finding of serum metabolomic features of cirrhotic patients.(December 2018)
研究者
ERICA VILLA
Professor
University of Modena and Reggio Emilia