Comparative Analysis on Short-term Efficacies of Two Kinds of Artificai Liver Method in Treating Severe Hepatitis B.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Number of Participants with death
研究概览
简要总结
This was a non-blinded, prospective clinical study. From June 2020 to October 2021, 254 patients with HBV-ACLF were treated at the Department of Infectious Diseases, Xiangya Hospital, Central South University (Changsha, China). 186 patients who met the enrollment criteria were included in this study. Inclusion criteria were as follows: (1) aged 18-65 years old; (2) patients with ACLF caused by HBV infection; (3) meeting the diagnostic criteria for ACLF by the Asian Pacific Association for the Study of Liver (APASL).The exclusion criteria were as follows: (1) pregnancy or lactation; (2) previous liver transplantation; (3) hepatocellular carcinoma or other malignancy; (4) human immunodeficiency virus(HIV) infection or other immunocompromised states; (5) complicated with underlying diseases such as severe heart, respiratory, and blood system diseases. Based on the inclusion and exclusion criteria, the investigators randomly matched patients at a 1:1:1 ratio to three groups whose age, sex ratio, complication, and liver function were comparable: comprehensive medical treatment (Control group), PE group, and DPMAS plus half-dose sequential PE (DPMAS + PE group). As a result, 62 subjects per group were recruited into the study. This study was approved by the Clinical Research Ethics Committee of Xiangya Hospital, Central South University with informed content obtained from all participants (No. 202201022). The study protocol followed the principles of the Helsinki Declaration strictly.
All the 186 patients enrolled received comprehensive medical treatment after admission to the hospital, including anti-viral treatment, general supportive treatment, supplementation of blood products, such as albumin and plasma, and symptomatic treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •aged 18-65 years old
- •patients with ACLF caused by HBV infection
- •meeting the diagnostic criteria for ACLF by the Asian Pacific Association for the Study of Liver.
排除标准
- •pregnancy or lactation
- •previous liver transplantation
- •hepatocellular carcinoma or other malignancy
- •human immunodeficiency virus(HIV) infection or other immunocompromised state
- •complicated with underlying diseases such as severe heart, respiratory, and blood system diseases
结局指标
主要结局
Number of Participants with death
时间窗: 90 days
Number of Participants with Liver transplantation
时间窗: 90 days
Number of Participants with survival without liver transplantation
时间窗: 90 days
次要结局
- Progress of biochemical indexes(90 days)
