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

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.

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03162419

Enrollment

Registered

2017-05-22

Start date

2017-05-01

Completion date

2019-04-25

Last updated

2018-12-03

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

Conditions

Acute-On-Chronic Liver Failure

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

Interventions

DRUGStandard Medical Therapy

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.

BIOLOGICALPlasma Exchange

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

BIOLOGICALGCSF

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Transplant free survival	28 days

Secondary

Measure	Time frame
Improvement in SOFA (by 2 points )	2 years
Incidence of new onset sepsis and SIRS in both groups.	Day 28
Side effects of therapy in both groups	2 years
Improvement in SIRS by 2 points	2 years
Improvement in clinical parameters which is defined as > 20% reduction from baseline in both groups	Day 14
Improvement in APACHEII (by 2 points )	2 years
Improvement in MELD (by 2 points )	2 years
Improvement in biochemical parameter which is defined as > 20% reduction from baseline in both groups	Day 14

Countries

India

Outcome results

None listed

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