Ignite Creation Date:
2024-05-05 @ 11:39 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01384565
Status:
COMPLETED
Last Update Posted:
2013-07-31
First Post:
2011-06-28
Brief Title:
G-CSF and Erythropoetin in Survival of Patients With Decompensated Liver Disease
Sponsor:
Institute of Liver and Biliary Sciences India
Organization:
Institute of Liver and Biliary Sciences India
Study Overview
Official Title:
A Prospective Randomized Double Blind Trial to Study the Efficacy of G-CSF and Erythropoetin in Survival of Patients With Decompensated Liver Disease
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None