Efficacy and Safety of Therapeutic Plasma Exchange vs Standard Medical Therapy in Severe Autoimmune Hepatitis.

• Study population: Patients presenting with severe autoimmune hepatitis and MELD>24 with no liver transplant option.
• Study design: A Pilot Randomised control trial
• Study period: 2 year
• Sample size:
• There is no studies of PE in severe AIH, assuming effect of PE in ACLF group
• Survival rate with plasma exchange was assumed to be 60 % and 20 % without PE.
• Further assuming 95% power and alpha 5 %.
• We need to enroll 46 cases i.e. 23 in each group
• Further assuming % defaulter rate, it is further decided to enroll 25 cases in each group.
• Patients will be randomly allocated in 2 groups by 1:1 block randomisation and will be implemented by IWRS facility taking block size 10.
• 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.
• Interim analysis would be done to check efficacy and safety of TPE in severe autoimmune hepatitis.
• 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

Inclusion criteria

• Age 18-60 years
• Acute severe autoimmune hepatitis with MELD >24
• No liver transplant option < 28 days.
• -ACLF + Non ACLF
• Auto immune hepatitis: Diagnosis by simplified AIH score ≥6

Exclusion criteria

• Patients with Active sepsis
• Patients with Active bleeding
• Patients allergic to FFP and blood products
• Patients with unstable hemodynamics ( eg:BP<90/60 mmhg,HR >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 >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