Iron Substitution After Upper Gastro-Intestinal Bleeding

University of Aarhus

Status and phase: Completed; Phase 4

Conditions: Anemia; Gastrointestinal Hemorrhage

Treatments: Drug: Placebo; Drug: ferricarboxymaltose; Drug: Ferrosulfate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00978575

Iron Gab

Details and patient eligibility

About

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.

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute upper gastrointestinal bleeding
• Anemia

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

97 participants in 3 patient groups, including a placebo group

Intravenous iron

Active Comparator group

Treatment:

Drug: ferricarboxymaltose

Oral iron

Active Comparator group

Treatment:

Drug: Ferrosulfate

Isotonic Sodium and placebo tablets

Placebo Comparator group

Treatment:

Drug: Placebo