NCT00978575

Iron Substitution After Upper Gastro-Intestinal Bleeding

Comparison of the Efficacy of Compliant Oral Iron Treatment (FerroDuretter ®) for 3 Months After Discharge Versus Single-dose of Intravenous Iron (Ferinject ®) Before Discharge in Patients With Acute Bleeding From Upper Gastrointestinal Tract. A Double Blinded Randomized Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gastrointestinal Hemorrhage
• Anemia

Interventions

Type	Name	Description
DRUG	ferricarboxymaltose	Single dose of maximum 1000 mg ferricarboxymaltose intravenous
DRUG	Ferrosulfate	200mg daily for 12 weeks
DRUG	Placebo	100 mg isotonic sodium and 2 placebo tablets daily

Timeline

• Start date: 2010-04-01
• Primary completion: 2013-01-01
• Completion: 2013-04-01
• First posted: 2009-09-17
• Last updated: 2013-04-05

Locations

1 site across 1 country: Denmark