Clinical trial NCT03162419: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute-On-Chronic Liver Failure
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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:

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

Primary outcomes:
measure: Transplant free survival
timeFrame: 28 days
Secondary outcomes:
measure: Improvement in biochemical parameter which is defined as > 20% reduction from baseline in both groups
timeFrame: Day 14
measure: Improvement in biochemical parameter which is defined as > 20% reduction from baseline in both groups
timeFrame: Day 28
measure: Improvement in clinical parameters which is defined as > 20% reduction from baseline in both groups
timeFrame: Day 14
measure: Improvement in clinical parameters which is defined as > 20% reduction from baseline in both groups
timeFrame: Day 28
measure: Improvement in APACHEII (by 2 points )
timeFrame: 2 years
measure: Improvement in MELD (by 2 points )
timeFrame: 2 years
measure: Improvement in SIRS by 2 points
timeFrame: 2 years
measure: Improvement in SOFA (by 2 points )
timeFrame: 2 years
measure: Incidence of new onset sepsis and SIRS in both groups.
timeFrame: Day 28
measure: Side effects of therapy in both groups
timeFrame: 2 years
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
References: