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.

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.

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Liver Disease
• Intervention / Treatment: Biological: High Volume Plasma Exchange; Other: Standard Medical Treatment

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Recruiting
      • Institute of Liver & Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	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)
Active Comparator: Standard Medical Treatment; Standard Medical Treatment (Albumin + High Caloric Diet)	Other: Standard Medical Treatment; Standard Medical Treatment (Albumin+High caloric diet)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Transplant free survival in both group	Day 28

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2019
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: July 9, 2019
• First Posted (Actual): July 11, 2019

Study Record Updates

• Last Update Posted (Actual): July 11, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Digestive System Diseases; Drug-Related Side Effects and Adverse Reactions; Poisoning; Liver Diseases; Chemical and Drug Induced Liver Injury
• Other Study ID Numbers: ILBS-Cirrhosis-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No