Iron Substitution After Upper Gastro-Intestinal Bleeding

Phase 4

Completed

• Conditions: Gastrointestinal Hemorrhage; Anemia
• Interventions: Drug: ferricarboxymaltose; Drug: Ferrosulfate; Drug: Placebo

• Registration Number: NCT00978575
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-16
• Study First Submitted QC: 2009-09-16
• Study First Posted: 2009-09-17
• Study Start: 2010-04
• Primary Completion: 2013-01
• Status Verified: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2013-04-04
• Last Update Posted: 2013-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

• Acute upper gastrointestinal bleeding
• Anemia

Exclusion Criteria

• Liver disease
• Terminal cancer
• Kidney disease
• variceal bleeding
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous iron	ferricarboxymaltose	-
Oral iron	Ferrosulfate	-
Isotonic Sodium and placebo tablets	Placebo	-

Primary Outcome Measures

Name	Time	Method
haemoglobin	13 weeks

Secondary Outcome Measures

Name	Time	Method
Quality of life Health economics	13 weeks, 6 and 12 months

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark