Efficacy of Plasma Exchange Therapy vs Standard Medical Therapy in Severe Alcoholic Hepatitis With High Discriminant Function

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Apr 3, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the effectiveness of a treatment called Plasma Exchange Therapy (TPE) compared to standard medical therapy for people with severe alcoholic hepatitis. Alcoholic hepatitis is a serious liver condition that can be life-threatening, with a high risk of death. Currently, there are limited treatment options available, mainly steroids, which do not work for everyone. The goal of this trial is to see if TPE can provide a better alternative for patients who are not responding to standard treatments and cannot receive a liver transplant right away.

To participate in this study, individuals need to be between 18 and 60 years old and have severe alcoholic hepatitis with specific medical criteria. They should not have any immediate options for a liver transplant and must be able to cover the costs of the plasma exchange themselves. Participants in the trial will receive either TPE or standard therapy and will be monitored throughout the study to see how well the treatments work. This trial is important because it aims to find new and effective ways to help patients who are struggling with this serious condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 to 60 years
• • 2. Severe alcoholic hepatitis with DF\>80\< 120 or MELD \>30
• • 3. No liver transplant option available in near future(for atleast 1 month)
• • 4. Patient able to bear the cost of Plasma exchange by himself/herself
• Exclusion Criteria:
• • 1. Active sepsis
• • 2. S creatinine \>1.5mg/dl
• • 3. Chronic kidney disease
• • 4. Pregnancy
• • 5. HCC or any other malignancy
• • 6. Active Bleeding
• • 7. Allergic to replacement fluid (FFP) in TPE
• • 8. Severe Hypocalcemia (\<7.6 mg/dl)
• • 9. Failure to give consent
• • 10. Financial issues to bear cost of Plasma exchange