About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
High volume Plasma Exchange
Biological/VaccineHigh volume Plasma Exchange with minimum 3 sessions on alternate days
Standard Medical Treatment
Other interventionStandard Medical Treatment includes stopping the offending drug,nutrition,injection NAC,Tablet UDCA,steroid in DILI AIH
Treatment groups
Trial outcomes
Primary outcomes
Liver Transplant free survival at the end of 30 days between two groups.
Secondary outcomes
Changes in arterial lactate levels, on lactate clearance at 0, 3, 5 days
Reduction in von Willebrand factor levels, endothelial function, and coagulopathy at 0 and 30 day.
Changes in the inflammatory milieu, IL6, IL10, and TNF alpha at 0 and 30 day.
Change in liver-related decompensation events (ascites, HE, variceal bleed) at 0, 3, 5,30, and 90 days.
Sponsors and contacts
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