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The purpose of the study is to determine whether Granulocyte Colony Stimulating factor(G-CSF) therapy is effective in the treatment of patients with Acute on chronic liver failure(ACLF). The investigators hypothesize that ACLF is a disease where severe hepatic impairment is accompanied by impaired hepatic regeneration. BMC mobilization using G-CSF therapy, or G-CSF therapy per se would increase the regenerative capacity of the liver and shall lead to clinical, biochemical and histological improvements in patients with ACLF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G-CSF group | Active Comparator | Patients with Acute on chronic liver failure after baseline investigations for the etiology of the acute event and the underlying chronic disease were given Granulocyte Colony Stimulating Factor therapy for a total duration of one month. |
|
| Placebo | Placebo Comparator | After baseline characterization and work up for underlying acute and chronic liver disease, patients were given placebo along with the standard therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Granulocyte Colony Stimulating Factor | Drug | Dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5, and then every 3rd day till day 28 (total 12 doses) along with the standard therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| mobilization of CD34 cells in the peripheral blood | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| clinical/ biochemical improvement in liver function profile | 2 months | |
| frequency of multi-organ failure | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shiv K Sarin, MD, DM | G B Pant Hospital, New Delhi, India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shiv K Sarin | Recruiting | New Delhi | New Delhi | 110002 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22119930 | Derived | Garg V, Garg H, Khan A, Trehanpati N, Kumar A, Sharma BC, Sakhuja P, Sarin SK. Granulocyte colony-stimulating factor mobilizes CD34(+) cells and improves survival of patients with acute-on-chronic liver failure. Gastroenterology. 2012 Mar;142(3):505-512.e1. doi: 10.1053/j.gastro.2011.11.027. Epub 2011 Nov 23. |
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| ID | Term |
|---|---|
| D065290 | Acute-On-Chronic Liver Failure |
| ID | Term |
|---|---|
| D017114 | Liver Failure, Acute |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| Normal Saline | Drug | dose of 1ml s/c at days 1, 2, 3, 4, 5, and then every 3rd day till day 28 (total 12 doses) along with the standard therapy. |
|
| D004066 |
| Digestive System Diseases |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |