Efficacy of plasma exchange in patients with acute on chronic Liver failure A randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- To compare survival over 30 days in PLEX and SMT arm
研究概览
简要总结
ACLF has a high short term mortality with the Standard Medical Treatment (SMT). Liver Transplantation (LT) is the only curative treatment. There are many devices that aim to artificially support liver function to bridge patients to liver transplantation and eventually allow for recompensation. Theraupeutic plasma exchange (PLEX) has shown to improve survival in few studies but has not been validated yet. Purpose of this study is to statistically compare and evaluate the 30 day survival in ACLF patients in PLEX patients vs SMT group. Also, improvement in renal failure , hepatic encephalopathy , PLEX related complications , duration of hospital stay , serial vWF levels are compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •All ethologies of ACLF as per APASAL criteria will be included in the study.
排除标准
- •Active sepsis Hemodynamic instability HIV infection Malignancy HCC Pregnancy Alcoholic hepatitis and Severe Alcoholic hepatitis.
结局指标
主要结局
To compare survival over 30 days in PLEX and SMT arm
时间窗: To compare survival over 30 days in PLEX and SMT arm
次要结局
- Improvement in renal dysfunction(Improvement in hepatic encephalopathy)
研究者
Dr Sandeep Nijhawan
SMS Medical College and Hospital, Jaipur
