GCSF in Alcoholic Hepatitis

The requested reference [dad7e44da6af212dea959801e6b64b5cc6980c2f] no longer exists in our database. It has been replaced by the current reference: [4262e9377fe36e531703a7bc975649e1c1359b9b]

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2017
Detailed Description: Patients with severe alcoholic hepatitis, admitted to Department of Hepatology PGIMER, Chandigarh will be included in the study. METHODS This will be an open label trial. A randomization code is generated by random number table. The patients will be randomized to receive standard medical therapy (SMT) only as control and therapy of G‐CSF as case. There will be one control and one case as below: 1) SMT (control) 2) G‐CSF (case): G‐CSF 5 mcg/kg every 12 hourly for consecutive 5 days This will be a single time therapy. Patients will be admitted in the department of hepatology and will be assessed everyday clinically as well as by laboratory tests during therapy to assess safety and effects of treatment. 1. Total leukocytes count will be assessed daily. 2. Circulating CD 34 positive cells will be measured on day 0 and 6 of G‐CSF therapy. 3. In addition, ultrasonography will be performed at day 1 and 6 in order to evaluate difference in spleen size and portal vein flow. 4. Biochemical, coagulation, and hematological parameters (Liver function tests, Renal Function Tests, Prothrombin Time, International Normalised Ratio, etc.) will be monitored periodically, daily for 1 week, then weekly for 1month and monthly for three month. All patients will be followed at weekly interval for 1 month and then monthly for 3 months. Outcome: Primary Objectives: Survival at 3 months Secondary Objectives: Mobilisation of CD34 positive cells in peripheral blood.Clinical/biochemical improvement in liver function profile.Improvement in prognostic scores‐Maddrey's Discriminant function, MELD score, and Child score. Safety and efficacy of G‐CSF in alcoholic hepatitis
Epistemonikos ID: 16b2156b985dc175c1d50aa1b9acd6b1ca47d32c
First added on: May 21, 2024