Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: Intravenous ferric carboxymaltose: intravenous ferric carboxymaltose (FCM) according to patients weight and hemoglobin of patient
fCM dose as given below-
Hemoglobin 10-14 g/dL with
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Raise in haemoglobin between two groups after 12 weeks post recovery from acute UGI bleedTimepoint: 1.Raise in haemoglobin between two groups after 12 weeks post recovery from acute UGI bleed | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with Hb increase greater than 2 g per dLiter compared to baselineTimepoint: 12 weeks after treatment allocation | — |
Countries
India
Contacts
Public ContactMohammad Tabish
All India Institute of Medical Sciences
Outcome results
None listed