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 Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Chronic Liver Disease

Intervention / Treatment
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* Biological: High Volume Plasma Exchange
* Other: Standard Medical Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Volume Plasma Exchange with SMT<br>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<br>* 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<br>Other: Standard Medical Treatment<br>* Standard Medical Treatment (Albumin+High caloric diet)<br>|
| Active Comparator: Standard Medical Treatment<br>Standard Medical Treatment (Albumin + High Caloric Diet) | Other: Standard Medical Treatment<br>* Standard Medical Treatment (Albumin+High caloric diet)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |