Efficacy of Plasma Exchange (procedure) Severe Alcoholic Hepatitis (liver disease).
Phase 3
- Conditions
- Health Condition 1: K746- Other and unspecified cirrhosis ofliver
- Registration Number
- CTRI/2024/03/064592
- Lead Sponsor
- Institute of Liver and Biliary Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Age 18 to 60 years
2.Severe alcoholic hepatitis with DFmore than 80 and less than 120 or MELD more than 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 more than 1.5mg per 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 (less than 7.6 mg per dl)
9.Failure to give consent
10.Financial issues to bear cost of Plasma exchange
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method iver transplant free survival at 28 days, 90 days.Timepoint: 28 days, 90 days.
- Secondary Outcome Measures
Name Time Method End of study period (90 Days)Timepoint: 90 days;Frequency of decompensation events on follow up periodTimepoint: 28 days;Mortality at 28 daysTimepoint: 28 days;Post therapy assessment in the form of clinical improvement (hepatic encephalopathy, ascites , improvement in jaundice)(both ascites and HE if present)Timepoint: 28 days