Comparing plasma exchange therapy to standard treatment for severe alcoholic hepatitis
Efficacy of Plasma Exchange Therapy vs Standard Medical Therapy in Severe Alcoholic Hepatitis With High Discriminant Function : A Randomised Controlled Trial
This study is testing if a special blood treatment called plasma exchange can help people with severe alcoholic hepatitis live longer compared to regular medical care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Institute of Liver and Biliary Sciences, India Academic / other |
| Locations | 1 site (New Delhi, Delhi) |
| Trial ID | NCT06355726 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of therapeutic plasma exchange compared to standard medical therapy in patients with severe alcoholic hepatitis who have a high discriminant function score. The hypothesis is that plasma exchange may improve overall survival by removing harmful substances from the blood. Patients will be randomly assigned to receive either plasma exchange or standard medical treatment after being assessed for eligibility. The study focuses on individuals who are not candidates for liver transplantation and have limited treatment options.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with severe alcoholic hepatitis and a discriminant function score between 80 and 120, who are not eligible for liver transplantation in the near future.
Not a fit: Patients with active sepsis, chronic kidney disease, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients with severe alcoholic hepatitis who currently have limited treatment options.
How similar studies have performed: While plasma exchange is an emerging treatment, this specific approach has not been widely tested in similar studies, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New Delhi, Delhi
- Institute of Liver & Biliary Sciences (ILBS) — New Delhi, Delhi, India (Recruiting)
Study contacts
- Study coordinator: Dr Jitendra Kumar Singh, MD
- Email: jitendra2602kc@gmail.com
- Phone: 01146300000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.