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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.

Primary Purpose

Chronic Liver Disease

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
High Volume Plasma Exchange
Standard Medical Treatment
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Liver Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Liver & Biliary SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Volume Plasma Exchange with SMT

Standard Medical Treatment

Arm Description

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)

Standard Medical Treatment (Albumin + High Caloric Diet)

Outcomes

Primary Outcome Measures

Transplant free survival in both group

Secondary Outcome Measures

Number of participants with the development of organ dysfunction or failure in both group
Number of participants with the development of organ dysfunction or failure in both group
Number of participants with the development of organ dysfunction or failure in both group

Full Information

First Posted
July 8, 2019
Last Updated
July 9, 2019
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT04015570
Brief Title
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.
Official Title
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
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 9, 2019 (Actual)
Primary Completion Date
July 1, 2020 (Anticipated)
Study Completion Date
July 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Liver Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Volume Plasma Exchange with SMT
Arm Type
Experimental
Arm Description
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)
Arm Title
Standard Medical Treatment
Arm Type
Active Comparator
Arm Description
Standard Medical Treatment (Albumin + High Caloric Diet)
Intervention Type
Biological
Intervention Name(s)
High Volume Plasma Exchange
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Standard Medical Treatment
Intervention Description
Standard Medical Treatment (Albumin+High caloric diet)
Primary Outcome Measure Information:
Title
Transplant free survival in both group
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Number of participants with the development of organ dysfunction or failure in both group
Time Frame
Day 7
Title
Number of participants with the development of organ dysfunction or failure in both group
Time Frame
Day 15
Title
Number of participants with the development of organ dysfunction or failure in both group
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Satyam Sinha, MD
Phone
01146300000
Email
satyamsinhacmc5@gmail.com
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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.

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