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

RECRUITINGN/ASponsored by Institute of Liver and Biliary Sciences, India
Actively Recruiting
PhaseN/A
SponsorInstitute of Liver and Biliary Sciences, India
Started2024-04-09
Est. completion2025-02-28
Eligibility
Age18 Years – 60 Years
Healthy vol.Accepted

Summary

Alcoholic hepatitis, the most florid form of alcoholic liver disease, has a very high short-term mortality of up to 50% and no specific therapies are available other than steroids. Steroids also only show a limited utility in improving the short-term survival and boast no evidence of any long-term benefits. Additionally, only a small proportion of patients with alcoholic hepatitis are eligible to receive steroids. Thus, a large number of patients are either not eligible or do not respond to steroids and this group outnumbers those who do respond to steroids, leaving us without any specific therapeutic options for a majority of these individuals.\[1\] Even liver transplantation is not feasible in most cases due to the presence of sepsis or recent alcohol consumption and many ethical and logistic issues are involved despite the documented safety and survival benefits of early liver transplantation in patients with severe alcoholic hepatitis (SAH) not responding to medical management.\[2,8\] Therefore, newer, more effective, and nontransplant therapeutic options for managing severe alcoholic hepatitis are needed. TPE is expected to be an effective and well-tolerated bridge therapy in patients with severe alcoholic hepatitis of moderate severity not improving on SMT and without immediate prospects for liver transplantation.

Eligibility

Age: 18 Years – 60 YearsHealthy volunteers accepted
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

Conditions2

Alcoholic HepatitisLiver Disease

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