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Completed

NCT Number: NCT00978575

Iron Substitution After Upper Gastro-Intestinal Bleeding

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.

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Key information

Conditions

Gastrointestinal Hemorrhage Anemia Digestive System Diseases Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute upper gastrointestinal bleeding
  • Anemia

Exclusion criteria

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

Treatment and study plan

ferricarboxymaltose

Drug

Single dose of maximum 1000 mg ferricarboxymaltose intravenous

Other names: Ferinject

Ferrosulfate

Drug

200mg daily for 12 weeks

Other names: FerroDuretter

Placebo

Drug

100 mg isotonic sodium and 2 placebo tablets daily

Primary outcomes

  1. haemoglobin

    Time frame: 13 weeks

Secondary outcomes

  1. Quality of life Health economics

    Time frame: 13 weeks, 6 and 12 months

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • GCP-unit at Aarhus University Hospital, Aarhus, Denmark
  • Vifor Pharma

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 17, 2009
Registry last updated
Apr 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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