To Study the Safety and Efficacy of G-CSF Therapy on the CD 34 Cell Mobilization and Outcome of Patients With ACLF
Overview
- Phase
- Not Applicable
- Intervention
- Granulocyte Colony Stimulating Factor
- Conditions
- Acute on Chronic Liver Failure
- Sponsor
- Govind Ballabh Pant Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- mobilization of CD34 cells in the peripheral blood
- Last Updated
- 16 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with acute hepatic insult manifesting as jaundice (Sr. Bil. ≥5 mg/dL) and coagulopathy (INR≥1.5), complicated within 4 weeks by ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease.(APASL criteria)
Exclusion Criteria
- •HCC or portal vein thrombosis. Refusal to participate in the study. Sepsis ( Any culture positive: blood, urine, focus of infection on Xray chest, any other obvious source of infection: UTI, SBP) Multi organ failure. Grade 3 or 4 hepatic encephalopathy.
Arms & Interventions
G-CSF group
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.
Intervention: Granulocyte Colony Stimulating Factor
Placebo
After baseline characterization and work up for underlying acute and chronic liver disease, patients were given placebo along with the standard therapy
Intervention: Normal Saline
Outcomes
Primary Outcomes
mobilization of CD34 cells in the peripheral blood
Time Frame: 1 month
Secondary Outcomes
- clinical/ biochemical improvement in liver function profile(2 months)
- frequency of multi-organ failure(2 months)