Treatment of iron deficiency anemia with intravenous ferric carboxymaltose versus oral carbonyl iron in patients with cirrhosis

Phase 4

Completed

• Conditions: Health Condition 1: K746- Other and unspecified cirrhosis ofliver

• Registration Number: CTRI/2022/11/047650
• Lead Sponsor: AIIMS New Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-05-01
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 92

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified