Effect of Single vs Repeated Cycles of a Combination of Granulocyte Colony Stimulating Factor and Darbepoetin vs Standard Medical Treatment on Immunometabolic Profile in Patient With Early Decompensated Cirrhosis.

Aim: To study the efficacy of single vs repeated cycle of Granulocyte Colony Stimulating Factor+ darbopoetin vs standard medical treatmenton immunometabolic profile in patient with early decompensated cirrhosis

Study population:

• Age 18-70 years
• Early decompensated cirrhosis MELD < 16 , CTP < 9B
• Uncomplicated ascites
• A Prospective Randomized Controlled Trial.
• Single Centre.
• Open label.
• Block Randomization will be done , it will be implemented by IWRS method.
• The study will be conducted in Department of Hepatology, ILBS.

Inclusion criteria

• Age 18-70 years
• Decompensated cirrhosis patients
• Uncomplicated ascites,
• CTP ≤ 9B and MELD <16
• BM Hematopoietic stem cell reserve > 0.4
• Given informed consent

Exclusion criteria

• Patients with age less than 18 years or more than 65 years
• Lack of informed consent
• Patients with a history of serious allergic reactions to the active component, filgrastim, other human granulocyte colony-stimulating factors, or any of the ingredients
• Evidence of alcoholic hepatitis/active alcohol abuse last intake ≤ 3 months
• Suspected autoimmune hepatitis (ANA/ASMA-positive in titers 1:80 and/ or IgG 1.5 times upper limit of normal),
• Hemolytic anaemia -Sickle cell disease or thalassemia
• Patients with Grade III ascites /complicated ascites
• Patients with large spleen (size ≥ 15cm)
• Recent variceal bleeding in less than 42 days
• Patients with any focus of sepsis as proven by culture positivity or presence of spontaneous Bacterial Peritonitis (SBP)
• H/o Seizures
• Hepatocellular Carcinoma (HCC) or other malignancy
• Acute Kidney Injury (AKI) with serum Creatinine >1.5 mg/ dl,
• Multi-organ failure,
• Hepatic Encephalopathy or prior history of HE in less than 6months
• HIV seropositivity,
• Uncontrolled essential hypertension, CAD /Stroke
• Massive hydrothorax
• Pregnancy
• Viral etiology of liver disease
• Chronic kidney disease
• Portal vein thrombosis
• Planned for LT
• Bone marrow hematopoietic stem cells < 0.4