Treatment of iron deficiency anemia with intravenous ferric carboxymaltose versus oral carbonyl iron in patients with cirrhosis after an episode of upper GI bleed: An open label randomised controlled trial

AIIMS New Delhi0 个研究点目标入组 92 人开始时间: 待定最近更新: 2024年5月27日

试验速览

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•Cirrhosis of liver with acute upper GI bleed and subsequent diagnosis of anemia (Hb <10 gm/dl) with iron deficiency (Ferritin < 100 µg/L) not meeting the exclusion criteria

•1.Bleeding secondary to causes other than cirrhosis Eg: extrahepatic venous obstruction, hepatic venous outflow tract obstruction
•2.Past GI surgery, Blood transfusion in last 6 months
•3.Pathologies that could influence the etiology of anemia such as hematological and gastrointestinal tract malignancies, chronic renal failure (rise in serum creatinine >1.5mg/dl in past 3 months), chronic heart failure, Inflammatory bowel disease, coeliac disease, uncontrolled thyroid disorder, Human immunodeficiency virus (I, II) positive, aplastic anemia, previous gastric surgery,
•4.Pregnancy and breastfeeding
•5.Treatment with erythropoietin, iron supplements
•6.History of allergic reaction to iron containing medications
•7.History of drug use known to cause anemia such as ribavirin
•8.Treatment with erythropoietin, iron supplements, folic acid or vitamin B12 in the 3 months prior to inclusion
•9.Acute on chronic liver failure defined according to Asia pacific association of liver disease definition
•10.Patients with cirrhosis with expected survival less than 6 months (child turcott pugh score >13 at presentation)
•11.Patients with alcoholic hepatitis
•12.Patients with evidence of infection at presentation
•a)Spontaneous bacterial peritonitis
•b)urinary tract infection
•c)pneumonia
•d)cellulitis
•e)SARS-COVID infection
•13.Failure to give consent

发起方

AIIMS New Delhi