To Assess the Efficacy of High-Volume Plasma Exchange and GCSF Versus GCSF Alone in Patients of Acute on Chronic Liver Failure (ACLF).

NCT03162419 | Withdrawn

• 1 other identifier: ILBS-ACLF-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Study design-Open label randomized controlled trial Study period-2 years Study population-All patients of ACLF admitted to ILBS for a period of two years from Feb 2017 to Dec 2018 All the patients of ACLF will receive standard medical therapy and will be randomized within 48 hours of admission into three groups after screening for exclusion and inclusion criteria.(1:2:2) Group A-Standard Medical Therapy only Group B-Standard Medical therapy + Plasma exchange + GCSF Group C-Standard Medical Therapy + GCSF

Conditions

Acute-On-Chronic Liver Failure

Outcome Measures

Primary Outcomes (1)

• Transplant free survival

  28 days

Secondary Outcomes (10)

• Improvement in biochemical parameter which is defined as > 20% reduction from baseline in both groups

  Day 14

• Improvement in biochemical parameter which is defined as > 20% reduction from baseline in both groups

  Day 28

• Improvement in clinical parameters which is defined as > 20% reduction from baseline in both groups

  Day 14

• Improvement in clinical parameters which is defined as > 20% reduction from baseline in both groups

  Day 28

• Improvement in APACHEII (by 2 points )

  2 years

Study Arms (3)

Standard Medical Therapy

ACTIVE COMPARATOR

The patients in group A will be given standard medical therapy only as per requirement. Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded.

Drug: Standard Medical Therapy

Standard Medical Therapy + Plasma exchange + GCSF

EXPERIMENTAL

The patients in group B shall be given GCSF in a dose of 5 ug/kg/day on day 1,2,3,4,5 followed by every 3rd day till day 28 along with alternate day high volume plasma exchange sessions till a maximum of ten sessions.

Drug: Standard Medical Therapy; Biological: Plasma Exchange; Biological: GCSF

Standard Medical Therapy + GCSF

EXPERIMENTAL

The patients in this will be given standard medical therapy only as per requirement. Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded. The GCSF in a dose of 5 ug/kg/day on day 1,2,3,4,5 followed by every 3rd day till day 28

Drug: Standard Medical Therapy; Biological: GCSF

Interventions

Standard Medical Therapy DRUG

The patients in group A will be given standard medical therapy only as per requirement. Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded.

Standard Medical Therapy; Standard Medical Therapy + GCSF; Standard Medical Therapy + Plasma exchange + GCSF

Plasma Exchange BIOLOGICAL

High volume plasma exchange sessions till a maximum of ten sessions.

Standard Medical Therapy + Plasma exchange + GCSF

GCSF BIOLOGICAL

The GCSF in a dose of 5 ug/kg/day on day 1,2,3,4,5 followed by every 3rd day till day 28

Standard Medical Therapy + GCSF; Standard Medical Therapy + Plasma exchange + GCSF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All consecutive patients in age group of 18-70 years with acute on chronic liver failure as defined by APASL criteria shall be included in the study.Only those patients who wish to be enrolled in the trial shall be included in the study.

You may not qualify if:

• Steroid eligible patients with severe alcoholic hepatitis
• Cirrhosis of liver with previous history of decompensation
• Patients with severe cardiopulmonary disease
• Pregnancy
• Human Immmunodeficiency Virus infection
• Hepatocellular carcinoma or extrahepatic malignancy
• Chronic renal insufficiency on treatment with haemodialysis
• Uncontrolled bleed or patients in disseminated intravascular coagulopathy
• Patient with expected survival of less than 48 hours
• Patients with moderate-severe acute respiratory distress syndrome
• Hemodynamic instability with noradrenaline requirement of more than \>0.5ug/kg/min or requirement of dual vasopressors
• Patients with leukemoid reaction or total leucocyte count \> 40,000/mm3
• Patients diagnosed with Hemophagocytic Lymphohistiocytosis
• Patients with known hypersensitivity to Granulocyte colony stimulating factor

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: May 22, 2017
• Study Start: May 1, 2017
• Primary Completion: April 25, 2019
• Study Completion: April 25, 2019
• Last Updated: December 3, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)