Efficacy and Safety of Plasma Exchange Compared to Standard Medical Therapy in Patients With Severe Drug Induced Liver Injury With or Without Underlying Chronic Liver Disease.
- Conditions
- Chronic Liver Disease
- Registration Number
- NCT04015570
- Lead Sponsor
- Institute of Liver and Biliary Sciences, India
- Brief Summary
In this randomized study subject will be randomized into two groups Group A will receive Standard Medical Treatment (Albumin + High Caloric Diet) Group B will continue Standard Medical Treatment with High Volume Plasma Exchange. All other interventions will be at the discretion of clinicians.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
-
Age-18-70 years
-
Preferably Biopsy proven or history suggestive of DILI (Drug Induced Liver Injury)
- Grade IV DILI With T.B > 15
- DILI Manifesting as ACLF (Acute on chronic Liver failure) /ALF (Acute Liver Failure) with no transplant option
- Evidence of active infection
- Refusal of consent or assent
- Patients with clinical suspicion of irreversible brain injury
- Pregnancy
- HCC (Hepatocellular Carcinoma) or any other malignancy
- Kidney failure
- Portal vein thrombosis
- Upper GastroIntestinal bleed
- Transplant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Transplant free survival in both group Day 28
- Secondary Outcome Measures
Name Time Method Number of participants with the development of organ dysfunction or failure in both group Day 28
Related Research Topics
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Trial Locations
- Locations (1)
Institute of Liver & Biliary Sciences
🇮🇳New Delhi, Delhi, India
Institute of Liver & Biliary Sciences🇮🇳New Delhi, Delhi, India