Overview

G-CSF and Erythropoetin in Survival of Patients With Decompensated Liver Disease

Status:
Completed

Trial end date:
2013-03-01

Target enrollment:
0

Participant gender:
All

Summary

Study Design 50 patients will be enrolled and randomized into patients (Group IA) and controls (Group I B) Investigations: Hematology CBC, Prothrombin time and INR Peripheral smear, Retics Biochemistry Liver function testing, AFP Kidney function testing Etiology of chronic liver disease Infectious etiology: total antiHBc, anti HCV, HCV RNA, HBV DNA Non infectious etiology: Autoimmune markers, copper studies, iron studies, HOMA IR, FBS Etiology of decompensation Variceal bleed Infection ( blood culture, urine culture, sputum culture, chest xray) Surgery Drugs Alcohol intake Ascitic fluid analysis UGI endoscopy Imaging USG abdomen with Doppler for spleno-portal axis CECT- Triple phase upper abdomen Liver regenerative potential efficacy testing Histology ( by transjugular liver biopsy) Liver Dendritic cells ( CD11c, CD40, CD 54, CD 123, BDCA 2 staining) by flow cytometry CD 34+ cells, CD 45+ cells and CD 133+ cells measurement in hepatic venous blood, peripheral blood and liver biopsy by flow cytometry Markers of proliferation like Ki- 67, proliferating cell nuclear antigen (PCNA) in liver biopsy Markers of angiogenesis like VEGF, v WF in hepatic venous blood Measurement of Hepatic venous pressure gradient ( HVPG)

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Institute of Liver and Biliary Sciences, India

Treatments:

Epoetin Alfa
Lenograstim

Criteria

Inclusion Criteria:

- All patients who were known to have cirrhosis of liver with portal hypertension, now
decompensated with ascites/ jaundice/ bleed/ HE/ HRS

Exclusion Criteria:

- Age <12 or > 75 years

- Autoimmune disorders

- HCC

- Sepsis ( Any culture positive: blood, urine, any other obvious source of
infection: UTI, SBP)

- Multi organ failure

- Grade 4 HE

- HIV seropositivity / pregnancy

- Essential Hypertension

- Patients being taken up for transplant

- Refusal to participate in the study