Status:
UNKNOWN
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.
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Chronic Liver Disease
Eligibility:
All Genders
18-70 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04015570
Start Date
July 9 2019
End Date
July 1 2020
Last Update
July 11 2019
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070