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

Primary Purpose

Acute-On-Chronic Liver Failure

Status
Withdrawn
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Standard Medical Therapy
Plasma Exchange
GCSF
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute-On-Chronic Liver Failure

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- 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.

Exclusion Criteria:

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

Sites / Locations

  • Institute of Liver and Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Standard Medical Therapy

Standard Medical Therapy + Plasma exchange + GCSF

Standard Medical Therapy + GCSF

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Transplant free survival

Secondary Outcome Measures

Improvement in biochemical parameter which is defined as > 20% reduction from baseline in both groups
Improvement in biochemical parameter which is defined as > 20% reduction from baseline in both groups
Improvement in clinical parameters which is defined as > 20% reduction from baseline in both groups
Improvement in clinical parameters which is defined as > 20% reduction from baseline in both groups
Improvement in APACHEII (by 2 points )
Improvement in MELD (by 2 points )
Improvement in SIRS by 2 points
Improvement in SOFA (by 2 points )
Incidence of new onset sepsis and SIRS in both groups.
Side effects of therapy in both groups

Full Information

First Posted
April 20, 2017
Last Updated
November 30, 2018
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT03162419
Brief Title
To Assess the Efficacy of High-Volume Plasma Exchange and GCSF Versus GCSF Alone in Patients of Acute on Chronic Liver Failure (ACLF).
Official Title
To Assess the Efficacy of High-Volume Plasma Exchange and GCSF Versus GCSF Alone in Patients of Acute on Chronic Liver Failure (ACLF)-A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of Funds.
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
April 25, 2019 (Anticipated)
Study Completion Date
April 25, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute-On-Chronic Liver Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Medical Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard Medical Therapy + Plasma exchange + GCSF
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Medical Therapy + GCSF
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Standard Medical Therapy
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Plasma Exchange
Intervention Description
High volume plasma exchange sessions till a maximum of ten sessions.
Intervention Type
Biological
Intervention Name(s)
GCSF
Intervention Description
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
Primary Outcome Measure Information:
Title
Transplant free survival
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Improvement in biochemical parameter which is defined as > 20% reduction from baseline in both groups
Time Frame
Day 14
Title
Improvement in biochemical parameter which is defined as > 20% reduction from baseline in both groups
Time Frame
Day 28
Title
Improvement in clinical parameters which is defined as > 20% reduction from baseline in both groups
Time Frame
Day 14
Title
Improvement in clinical parameters which is defined as > 20% reduction from baseline in both groups
Time Frame
Day 28
Title
Improvement in APACHEII (by 2 points )
Time Frame
2 years
Title
Improvement in MELD (by 2 points )
Time Frame
2 years
Title
Improvement in SIRS by 2 points
Time Frame
2 years
Title
Improvement in SOFA (by 2 points )
Time Frame
2 years
Title
Incidence of new onset sepsis and SIRS in both groups.
Time Frame
Day 28
Title
Side effects of therapy in both groups
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - 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. Exclusion Criteria: 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
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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