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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.

Not Applicable
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
Inclusion Criteria
  • Age-18-70 years

  • Preferably Biopsy proven or history suggestive of DILI (Drug Induced Liver Injury)

    1. Grade IV DILI With T.B > 15
    2. DILI Manifesting as ACLF (Acute on chronic Liver failure) /ALF (Acute Liver Failure) with no transplant option
Exclusion Criteria
  • 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
NameTimeMethod
Transplant free survival in both groupDay 28
Secondary Outcome Measures
NameTimeMethod
Number of participants with the development of organ dysfunction or failure in both groupDay 28

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences

🇮🇳

New Delhi, Delhi, India

Institute of Liver & Biliary Sciences
🇮🇳New Delhi, Delhi, India

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