Efficacy of Plasmapheresis in Patients of Drug-Induced Liver Injury (DILI) With Underlying Chronic Liver Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High volume Plasma Exchange, Standard Medical Treatment.
- Who it may be relevant to
- Registry conditions: Drug Induced Liver Injury, Chronic Liver Disease. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Plasmapheresis in Patients of Drug-Induced Liver Injury (DILI) With Underlying Chronic Liver Disease: An Open Labelled RCT
Overview
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.
Detailed description
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.
Interventions
- Biological High volume Plasma Exchange
High volume Plasma Exchange with minimum 3 sessions on alternate days - Other Standard Medical Treatment
Standard Medical Treatment includes stopping the offending drug,nutrition,injection NAC,Tablet UDCA,steroid in DILI AIH
Primary outcome measures
- Liver Transplant free survival at the end of 30 days between two groups. [Time frame: 30 days]
Secondary outcome measures (5)
- Changes in arterial lactate levels, on lactate clearance at 0, 3, 5 days [Time frame: 0, 3, 5 days]
- Reduction in von Willebrand factor levels, endothelial function, and coagulopathy at 0 and 30 day. [Time frame: 0 and 30 day.]
- Changes in the inflammatory milieu, IL6, IL10, and TNF alpha at 0 and 30 day. [Time frame: 0 and 30 day.]
- Change in liver-related decompensation events (ascites, HE, variceal bleed) at 0, 3, 5,30, and 90 days. [Time frame: 0, 3, 5,30, and 90 days.]
- Change in serum bilirubin and bile acids clearance at 0, 3, 5,30 and 90 days. [Time frame: 0, 3, 5,30 and 90 days.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
India · 1 center
- Institute of Liver & Biliary Sciences (ILBS) — New Delhi
Identifiers
NCT: NCT06797011 · ILBS-DILI-01