Iron Substitution After Upper Gastro-Intestinal Bleeding

University of Aarhus97 enrolled

Overview

The trial is a double-blind randomized trial designed to examine whether compliant iron therapy (intravenous or oral) for 3 months after discharge increases hemoglobin levels more and faster than no treatment - in patients with acute bleeding from upper gastrointestinal tract. The trial will include 126 patients at Aarhus University Hospital. In addition to efficacy assessment quality of life assessment and health economic calculations between the treatments will be compared.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Gastrointestinal Hemorrhage Anemia

Interventions

ferricarboxymaltoseDRUG

Single dose of maximum 1000 mg ferricarboxymaltose intravenous

FerrosulfateDRUG

200mg daily for 12 weeks

PlaceboDRUG

100 mg isotonic sodium and 2 placebo tablets daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Acute upper gastrointestinal bleeding * Anemia Exclusion Criteria: * Liver disease * Terminal cancer * Kidney disease * variceal bleeding * Pregnancy

Locations (1)

Aarhus University Hospital

Aarhus, Aarhus, Denmark

Outcomes

Primary Outcomes

haemoglobin

Time frame: 13 weeks

Secondary Outcomes

Quality of life Health economics

Time frame: 13 weeks, 6 and 12 months

Data from ClinicalTrials.gov

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