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

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Jan 27, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the use of a treatment called plasmapheresis for patients who have experienced drug-induced liver injury (DILI) and also have underlying chronic liver disease. DILI can cause serious liver problems, and this study aims to see if plasmapheresis, which helps remove harmful substances from the blood, can improve outcomes for these patients. The trial will focus on adults aged 18 to 75 who meet specific criteria, such as having high levels of bilirubin (a substance that can indicate liver problems) and a diagnosis of DILI.

To participate in the study, individuals must agree to join and meet certain health conditions, including not having active infections or severe health issues that would make plasmapheresis unsafe. Those who are pregnant, have certain cancers, or significant kidney problems are not eligible. While the trial is not yet recruiting participants, if you or a loved one qualifies, you can expect close monitoring and support throughout the study to see how this treatment works for liver injury caused by medications.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults aged 18-75 years with previously known or unknown underlying CLD.
• • 2. Diagnosis of DILI based causality of assessment by RECAM.
• • 3. Severe DILI with bilirubin \> 12mg/dl or INR\>2, S.Bili \>5 mg/dl.
• • 4. Consent to participate in the study (based on biopsy/imaging/or clinical criteria).
• Exclusion Criteria:
• • 1. Active infection
• • 2. Contraindications to plasmapheresis (e.g., severe coagulopathy, hemodynamic instability, patients with sepsis, shock, poor P/F ratio).
• • 3. Pregnant or breastfeeding women.
• • 4. HCC or any malignancy
• • 5. UGI bleed, uncontrolled HE
• • 6. Option LTx being considered
• • 7. S. Creatinine \> 2mg/dL
• • 8. DILI ALF
• • 9. Alcoholic Hepatitis