The Prevalence and Severity of HCV Infection in Thalassemia Major and Thalassemia Intermedia in Siriraj Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Prevalence and genotypes of HCV infection in thalassemia major and thalassemia intermediate patients who have received blood transfusion in the Department of Medicine, Faculty of Medicine Siriraj Hospital
研究概览
简要总结
The primary objective is to assess the prevalence and genotypes of HCV infection in thalassemia major and thalassemia intermediate patients who have received blood transfusion in the Department of Medicine, Faculty of Medicine Siriraj Hospital.
The secondary objective is to identify the effect of HCV infection as well as the risk factors of advanced liver disease and liver cirrhosis in these patients
The third objective is to identify the role of serum HA level and fibrotest in the prediction of cirrhosis in these patients.
详细描述
Study protocol
Data collection:
The eligible patients will be asked to participate in the study. After signing informed consent, the patients will be asked to complete questionnaire, all clinical and laboratory data of the patients will be retrieved from out-patient electronic or paper medical records, electronic laboratory results. The data will include the followings:
- Clinical data
- Demographic information (age, gender, ethnicity, education, marital status)
- Family history of liver disease
- Current relevant medication
- Weight, height and body mass index (BMI) at the time of enrollment
- History of blood or blood product transfusion, last transfusion
- History of alcohol consumption
- History of active liver disease
- Laboratory data
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously diagnosed thalassemia major, for example homozygous beta thalassemia or beta thalassemia/hemoglobin E disease or thalassemia intermedia such as hemoglobin H disease or homozygous Hb CS
- •Age equal to or more than 18 years
- •Previous history of blood transfusion
排除标准
- •Patients who have hepatocellular carcinoma, ascites or pregnancy will be excluded from the study due to the limitation of result interpretation.
- •Unwilling to participate
- •Patient who receiving or completed treatment of hepatitis C
结局指标
主要结局
Prevalence and genotypes of HCV infection in thalassemia major and thalassemia intermediate patients who have received blood transfusion in the Department of Medicine, Faculty of Medicine Siriraj Hospital
时间窗: 1 year
次要结局
- Role of serum HA level and fibrotest in the prediction of cirrhosis in thalassemia major and thalassemia intermediate patients who have received blood transfusion in the Department of Medicine, Faculty of Medicine Siriraj Hospital.(1 year)
- Effect of HCV infection and the risk factors of advanced liver disease and liver cirrhosis in thalassemia major and thalassemia intermediate patients who have received blood transfusion(1 year)