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Clinical Trials/CTRI/2022/11/047650
CTRI/2022/11/047650
Completed
Phase 4

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 sites92 target enrollmentTBD
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ConditionsHealth Condition 1: K746- Other and unspecified cirrhosis ofliver

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Sponsor
AIIMS New Delhi
Enrollment
92
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
May 1, 2023
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
AIIMS New Delhi

Eligibility 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

  • •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)

Outcomes

Primary Outcomes

Not specified

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