Efficacy of Plasmapheresis in Patients of severe Drug-Induced Liver Injury (DILI) with underlying chronic liver disease: An open labelled RCT.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Liver Transplant free survival at the end of 30 days between two groups.
研究概览
简要总结
DILI is an underdiagnosed and under appreciated causal or contributing factor to liver injury. DILI can mimics features of the entire spectrum of acute and chronic liver disease.
Asia–Pacifc region is characterized by two unique features; the high prevalence of tuberculosis (TB) in the population and the ubiquitous use of traditional and complimentary medicines.Current definition of Hy’s law presents significant difficulties when dealing with patients with preexisting CLD in clinical trials. Hallmark of the hepatic manifestation in these patients is hyperbilirubinemia and coagulopathy rather than ALT elevation.
Study Design Single-center, non-blinded, parallel group, randomized controlled trial. Allocation ratio between two groups: 1:1.
Study population: Adults aged 18-75 years with previously known or unknown underlying CLD. Diagnosis of DILI-based causality of assessment by RECAM. Severe DILI with bilirubin > 12mg/dl or INR>2, S.Bili >5 mg/dl Consent to participate in the study (based on biopsy, imaging or clinical criteria).
Study design: RCT
Study period: 1 year
Sample size: 96
Intervention: Patients after screening for all exclusion criteria will be randomized into either the standard treatment group or the plasma exchange group.
Monitoring and assessment: All patients would undergo vital and baseline parameter screening before randomization. Based on randomization they will receive either steroid or plasma exchange followed by steroid.
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 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18-75 years with previously known or unknown underlying CLD
- •Diagnosis of DILI based causality of assessment by RECAM.
- •Severe DILI with bilirubin more than 12mg/dl or INR ore than 2, S.Bili more than 5 mg per dl
- •Consent to participate in the study (based on biopsy/imaging/or clinical criteria).
排除标准
- •Active infection
- •Contraindications to plasmapheresis (e.g., severe coagulopathy, hemodynamic instability, patients with sepsis, shock, poor PF ratio).
- •Pregnant or breastfeeding women.
- •HCC or any malignancy
- •UGI bleed, uncontrolled HE
- •Option LTx being considered
- •Creatinine more than 2mg/dL
- •Alcoholic Hepatitis.
结局指标
主要结局
Liver Transplant free survival at the end of 30 days between two groups.
时间窗: 30 days
次要结局
- Changes in arterial lactate levels, on lactate clearance at 0, 3, 5 days(0, 3, 5 days)
- Change in serum bilirubin and bile acids clearance at 0, 3, 5,30 and 90 days(0, 3, 5,30 and 90 days)
- Reduction in von Willebrand factor levels, endothelial function, and coagulopathy at 0 and 30 day.(0 and 30 day.)
- Changes in arterial lactate levels, on lactate clearance at 0,3 days(0,3 days)
- Changes in the inflammatory milieu, IL6, IL10, and TNF alpha at 0 and 30 day(0 and 30 day)
- Change in liver-related decompensation events (ascites, HE, variceal bleed) at 0, 3, 5,30, and 90 days.(0, 3, 5,30, and 90 days)
- Change in serum bilirubin and bile acids clearance at 0, 3, 5,30 and 90 days.(0, 3, 5,30 and 90 days.)
研究者
Dr Khushboo Yadav
Institute of Liver and Biliary Sciences