Efficacy of Plasmapheresis in Patients of Drug-Induced Liver Injury (DILI) With Underlying Chronic Liver Disease

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.

Inclusion criteria

• 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).

Exclusion criteria

• Active infection
• Contraindications to plasmapheresis (e.g., severe coagulopathy, hemodynamic instability, patients with sepsis, shock, poor P/F ratio).
• Pregnant or breastfeeding women.
• HCC or any malignancy
• UGI bleed, uncontrolled HE
• Option LTx being considered
• S. Creatinine > 2mg/dL
• DILI ALF
• Alcoholic Hepatitis