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.

Overview

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.

Full Title of Study: “A Randomized Controlled Trial to Study the 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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 1, 2020

Interventions

  • Biological: High Volume Plasma Exchange
    • PLASMA EXCHANGE is therapeutic procedure in which blood of the patient is passed through a medical device which separates plasma from other components of blood. The plasma is removed and replaced with a replacement solution such as colloid solution (e.g., albumin and/or plasma) or a combination of crystalloid/colloid solution.Plasma exchange leads to removal of abnormal circulating plasma factor or a physiologic factor produced in excess (IG, NH3,protein bond toxins )and also exert a immunomodulatory activity
  • Other: Standard Medical Treatment
    • Standard Medical Treatment (Albumin+High caloric diet)

Arms, Groups and Cohorts

  • Experimental: High Volume Plasma Exchange with SMT
    • PLASMA EXCHANGE is therapeutic procedure in which blood of the patient is passed through a medical device which separates plasma from other components of blood. The plasma is removed and replaced with a replacement solution such as colloid solution (e.g., albumin and/or plasma) or a combination of crystalloid/colloid solution.Plasma exchange leads to removal of abnormal circulating plasma factor or a physiologic factor produced in excess (IG, NH3,protein bond toxins )and also exert a immunomodulatory activity. Standard Medical Treatment (Albumin + High Caloric Diet)
  • Active Comparator: Standard Medical Treatment
    • Standard Medical Treatment (Albumin + High Caloric Diet)

Clinical Trial Outcome Measures

Primary Measures

  • Transplant free survival in both group
    • Time Frame: Day 28

Secondary Measures

  • Number of participants with the development of organ dysfunction or failure in both group
    • Time Frame: Day 7
  • Number of participants with the development of organ dysfunction or failure in both group
    • Time Frame: Day 15
  • Number of participants with the development of organ dysfunction or failure in both group
    • Time Frame: Day 28

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institute of Liver and Biliary Sciences, India
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Dr Satyam Sinha, MD, 01146300000, satyamsinhacmc5@gmail.com

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