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.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04015570

Enrollment

Registered

2019-07-11

Start date

2019-07-09

Completion date

2020-07-01

Last updated

2019-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Liver Disease

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.

Interventions

BIOLOGICALHigh 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

OTHERStandard Medical Treatment

Standard Medical Treatment (Albumin+High caloric diet)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Transplant free survival in both group	Day 28

Secondary

Measure	Time frame
Number of participants with the development of organ dysfunction or failure in both group	Day 7

Countries

India

Contacts

Primary ContactDr Satyam Sinha, MD

satyamsinhacmc5@gmail.com01146300000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026