DRUG
To Study the Influence of GCSF on Natural History of Acute On Chronic Liver Failure After the Acute Phase
Status
Terminated
Phase
Not applicable
Enrollment
14
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
All consecutive ACLF (Acute on Chronic Liver failure) patients presenting to the institute of liver and biliary sciences, irrespective of the etiology , who have survived the acute phase (i.e. 90 days of onset of the acute on chronic liver failure) and who are willing to participate in the study would be enrolled. After performing baseline biochemical tests, patients will undergo transjugular liver biopsy (TJLB), HVPG (Hepatic Venous Pressure Gradient), Circulating CD34 cells, Bone marrow aspiration and biopsy (Histopathological and immunohistochemical examination will be done).
Interventions
Treatment arms and agents.
BIOLOGICAL
20% Albumin
DIETARY_SUPPLEMENT
Nutrition
OTHER
Bowel wash
DRUG
Terlipressin 1- 4mg,if indicated
DRUG
Meropenem or Imepenem, if indicated
DRUG
Placebo
Timeline
From registration to results.
First posted
Jun 2, 2016
Study start
May 1, 2016
Primary completion
Jul 15, 2017
Study completion
Jul 15, 2017
Results posted
Not reported
Registry updated
Feb 6, 2018
Outcomes
What the study measures.
Primary outcomes
Transplant free survival in both groups
Time frame · 1 year
Secondary outcomes
Quantitative assessment of CD34 positive cells in serum in both groups.
Time frame · 1 year
On Immunohistochemistry of liver biopsy tissue,quantification of + ve CD34 cells will be done
Quantitative assessment of CD34 positive cells in liver biopsy samples in both groups.
Time frame · 1 year
On Immunohistochemistry of liver biopsy tissue,quantification of + ve CD34 cells will be done
Reduction in liver disease severity indices like CTP (Child-Turcotte-Pugh) by more than one point in both groups.
Time frame · 1 year
Reduction in liver disease severity indices like MELD Na ((Model for End Stage liver disease) by more than 2 points in both groups.
Time frame · 1 year
Development of new onset complications such as hepatic encephalopathy in both groups.
Time frame · 1 year
Development of new onset complications such as hepatorenal syndrome in both groups.
Time frame · 1 year
Development of new onset complications such as sepsis in both groups.
Time frame · 1 year
Development of new onset complications such as Hepatocellular carcinoma (HCC).
Time frame · 1 year
Total number of CD34 positive cells in histopathological examination of bone marrow in both groups
Time frame · 1 year
No of adverse events in both groups
Time frame · 1 year
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Subjects aged 18-65 years * All patients who were known to have ACLF and have survived 3 months of the onset of acute event * Patients willing to participate in the study Exclusion Criteria: * Presence of AKI (Acute Kidney Injury) * Active sepsis (Blood/ urine culture positive, SBP (Spontaneous bacterial Peritonitis, LRTI (lower Respiratory Tract infection) * Sickle cell anemia * HepatoCellular Carcinoma * Hematological malignancies * Multi organ failure * Grade 3/ 4 HE (Hepatic Encephalopathy) * HIV seropositivity * Pregnancy * Patients being taken up for transplant * Refusal to participate in the study
Study locations
1 registered sites.
India. Showing up to 24 locations stored in the fast local snapshot.
Institute of liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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