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
• Interventions: Biological: High Volume Plasma Exchange; Other: Standard Medical Treatment

• 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

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-08
• Study Start: 2019-07-09
• Study First Submitted QC: 2019-07-09
• Last Update Submitted: 2019-07-09
• Study First Posted: 2019-07-11
• Last Update Posted: 2019-07-11
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-01

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

Arm && Interventions

Group	Intervention	Description
High Volume Plasma Exchange with SMT	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. Standard Medical Treatment (Albumin + High Caloric Diet)
Standard Medical Treatment	Standard Medical Treatment	Standard Medical Treatment (Albumin + High Caloric Diet)
High Volume Plasma Exchange with SMT	Standard Medical Treatment	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)

Primary Outcome Measures

Name	Time	Method
Transplant free survival in both group	Day 28

Secondary Outcome Measures

Name	Time	Method
Number of participants with the development of organ dysfunction or failure in both group	Day 28

Trial Locations

Locations (1)

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