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.

Institute of Liver and Biliary Sciences, India

Status: Unknown

Conditions: Chronic Liver Disease

Treatments: Other: Standard Medical Treatment; Biological: High Volume Plasma Exchange

Study type: Interventional

Funder types: Other

Identifiers

NCT04015570

ILBS-Cirrhosis-24

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

High Volume Plasma Exchange with SMT

Experimental group

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)

Treatment:

Other: Standard Medical Treatment

Biological: High Volume Plasma Exchange

Standard Medical Treatment

Active Comparator group

Description:

Standard Medical Treatment (Albumin + High Caloric Diet)

Treatment:

Other: Standard Medical Treatment