Efficacy and Safety of Therapeutic Plasma Exchange vs Standard Medical Therapy in Severe Autoimmune Hepatitis. A Pilot Randomized Controlled Study.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Reduction in AST,ALT,Bilirubin
研究概览
简要总结
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Study population: Patients presenting with severe autoimmune hepatitis and MELD>24 with no liver transplant option.
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Study design: A Pilot Randomised control trial
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Study period: 2 year
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Sample size:
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There is no studies of PE in severe AIH, assuming effect of PE in ACLF group
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Survival rate with plasma exchange was assumed to be 60 % and 20 % without PE.
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Further assuming 95% power and alpha 5 %.
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We need to enroll 46 cases i.e. 23 in each group
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Further assuming % defaulter rate, it is further decided to enroll 25 cases in each group.
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Patients will be randomly allocated in 2 groups by 1:1 block randomisation and will be implemented by IWRS facility taking block size 10.
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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.
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Interim analysis would be done to check efficacy and safety of TPE in severe autoimmune hepatitis.
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Adverse effects:
Therapeutic Plasma Exchange is associated with risk of adverse events like infections,Fluid overload or circulatory insufficiency, Hypersensitivity to blood products.
- Stopping rule:
Study will be stopped in case of life- threatening events occur in patient after randomisation
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18-60 years
- •Acute severe autoimmune hepatitis with MELD more than 24
- •No liver transplant option less than 28 days.
- •ACLF and Non ACLF
- •Auto immune hepatitis: Diagnosis by simplified AIH score more than equals to 6.
排除标准
- •Patients with Active sepsis
- •Patients with Active bleeding
- •Patients allergic to FFP and blood products
- •Patients with unstable hemodynamics ( eg BP less than 90 by 60 mmhg,HR more than 100bpm)
- •Patients with post renal obstructive AKI, AKI suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis
- •Pregnancy related liver failure
- •Comorbidities associated with poor outcome (Extrahepatic neoplasia, severe cardiopulmonary disease defined by a New York Heart Association score more than 3, or oxygen/steroid-dependent chronic obstructive pulmonary disease)
- •Refusal to participate in the study
- •Patients who are eligible to transplant
- •Patients who received steroids or on steroids last 7 days.
结局指标
主要结局
Reduction in AST,ALT,Bilirubin
时间窗: 28 days
次要结局
- Infections at 28 days.(28 days)
- Liver transplant free survival at 28 days(28 days)
- Development of adverse event due to TPE.(28 days)
- Development of clinical infection during study period.(28 days)
- Mortality during hospital stay.(28 days)
- Post therapy assessment in the form of clinical improvement (hepatic encephalopathy, ascites , improvement in jaundice)(both ascites and HE if present).(28 days)
- Frequency of decompensation events on follow up period.(28 days)
研究者
Dr JGnana Kavitha
Institute of Liver and Biliary Sciences