Suspended

A Randomized Controlled Trial of Efficacy and Safety of Hemoperfusion or Plasma Exchange Compared to Standard Medical Therapy in Patients With Acute on Chronic Liver Failure

What is being tested

Haemoperfusion

+ Standard Medical Treatment

+ Plasma Exchange

DrugOther

Who is being recruted

Digestive System Diseases+3

+ Liver Diseases

+ Liver Failure

From 18 to 65 Years

+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: July 2019

See protocol details

Summary

Principal SponsorInstitute of Liver and Biliary Sciences, India

Study ContactDr Vinay Kumar, MD

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 9, 2019

Actual date on which the first participant was enrolled.

The study is done with the aim of finding the association between the bilirubin and bile acids / DAMPS molecule with organ failures and sepsis in the patients with acute on chronic liver failure . in this study there are 2 parts in the first part people who satisfy the eligibility criteria will be recruited and blood samples will be taken and above mentioned molecules will be analyzed and association ,if any with occurrences of organ failures / new onset sepsis will be analyzed . In the second part of the study the patients who meet the criteria will be randomized to either receive standard medical therapy or with either haemoperfusion or therapeutic plasma exchange with standard medical therapy . blood samples will be taken and stored, bile acids (primary and secondary bile acids, bilirubin and damps molecules will be analysed .the patients are followed for 90 days , then statistical analysis will be done to find the association with organ failures and new onset sepsis .

Official TitleA Randomized Controlled Trial of Efficacy and Safety of Hemoperfusion or Plasma Exchange Compared to Standard Medical Therapy in Patients With Acute on Chronic Liver Failure

NCT04013113

Principal SponsorInstitute of Liver and Biliary Sciences, India

Study ContactDr Vinay Kumar, MD

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

250 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesLiver DiseasesLiver FailureLiver Failure, AcuteHepatic InsufficiencyAcute-On-Chronic Liver Failure

Criteria

2 inclusion criteria required to participate

Patients diagnosed with ACLF as per APASL criteria will be included.

Age : 18-65 yrs.

5 exclusion criteria prevent from participating

Patient with chronic renal insufficiency.

Patient with ischemic heart disease

Patient with chronic obstructive disease.

Patient with hepato cellular carcinoma.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Active Comparator

Group A will be given standard medical therapy only included as per requirement.nutritional therapy ( high calorie intake- 2400 Kcal/ day) Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Institute of Liver & Biliary Sciences

New Delhi, IndiaOpen Institute of Liver & Biliary Sciences in Google Maps

SuspendedOne Study Center