Clinical Trial: To Study the Influence of GCSF on Natural History of Acute On Chronic Liver Failure After the Acute Phase

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: To Study the Influence of GCSF on Natural History of Acute On Chronic Liver Failure After the Acute Phase - A Randomized Controlled Study

Brief Summary: 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).

Detailed Summary:
Sponsor: Institute of Liver and Biliary Sciences, India

Current Primary Outcome: Transplant free survival in both groups [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
  • Reduction in HVPG (Hepatic Venous Pressure Gradient) in both groups [ Time Frame: 1 year ]
  • Reduction in HBV DNA level in both groups. [ Time Frame: 1 year ]
  • Number of patients who will restart alcohol abuse during the follow up period in both groups. [ Time Frame: 1 year ]


Original Secondary Outcome: Same as current

Information By: Institute of Liver and Biliary Sciences, India

Dates:
Date Received: March 22, 2016
Date Started: May 2016
Date Completion: May 2017
Last Updated: November 28, 2016
Last Verified: November 2016