Effects of drug (Tenofovir, FMT, Plasma Exchange therapy) in Liver Disease (ACLF-HBV).
Not Applicable
- Conditions
- Health Condition 1: B181- Chronic viral hepatitis B withoutdelta-agentHealth Condition 2: K769- Liver disease, unspecified
- Registration Number
- CTRI/2020/06/026062
- 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 - 18-75 years
2) Patients with ACLF - HBV reactivation according to APASL guidelines.
3) MELD < 30 WITH AKI,HE
4) MELD < 30 WITH OUT EXTRAHEPATIC FAILURE
Exclusion Criteria
1) MELD > 30
2) Co existing hepatitis A,E,D
3) HCC
4) Sepsis
5) Alcohol intake, substance abuse, HIV, IBD, chronic constipation or diarrhoea
6) Allergy to plasma, protamine or heparin,
7) Active hemorrhage or disseminated intravascular coagulation (DIC)
8) Unstable hemodynamics (e.g., blood pressure <90/60 mmHg, heart rate >100 bpm),
9) Cerebral or myocardiac infarction
10) Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival at 28 days.Timepoint: 28 days
- Secondary Outcome Measures
Name Time Method Adverse Events in both groupsTimepoint: 90 days;Change in microbiota bacteria profileTimepoint: 10,30,60 and 90 days;Change in plasma cytokine profileTimepoint: 10,28 and 60 days;Improvement in CTP and MELD ScoresTimepoint: 14,30,60 and 90 days;Overall survival at 3 monthsTimepoint: 3 months;Reduction in HBV DNA levelTimepoint: 14,60 and 90 days