Iron Substitution After Upper Gastro-Intestinal Bleeding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00978575
Recruitment Status : Completed
First Posted : September 17, 2009
Last Update Posted : April 5, 2013
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
Vifor Pharma
Information provided by (Responsible Party):
Palle Bager, 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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Hemorrhage Anemia Drug: ferricarboxymaltose Drug: Ferrosulfate Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : April 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Intravenous iron Drug: ferricarboxymaltose
Single dose of maximum 1000 mg ferricarboxymaltose intravenous
Other Name: Ferinject
Active Comparator: Oral iron Drug: Ferrosulfate
200mg daily for 12 weeks
Other Name: FerroDuretter
Placebo Comparator: Isotonic Sodium and placebo tablets Drug: Placebo
100 mg isotonic sodium and 2 placebo tablets daily

Primary Outcome Measures :
  1. haemoglobin [ Time Frame: 13 weeks ]

Secondary Outcome Measures :
  1. Quality of life Health economics [ Time Frame: 13 weeks, 6 and 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Acute upper gastrointestinal bleeding
  • Anemia

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00978575

Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
Vifor Pharma
Study Chair: Hendrik Vilstrup, Professor Aarhus University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Palle Bager, Clinical Nurse Specialist, RN, MPH, University of Aarhus Identifier: NCT00978575     History of Changes
Other Study ID Numbers: Iron Gab
First Posted: September 17, 2009    Key Record Dates
Last Update Posted: April 5, 2013
Last Verified: April 2013

Keywords provided by Palle Bager, University of Aarhus:
Iron treatment
Upper gastrointestinal bleeding

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Trace Elements
Growth Substances
Physiological Effects of Drugs