Iron Substitution After Upper Gastro-Intestinal Bleeding

April 4, 2013 updated by: Palle Bager, University of Aarhus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acute upper gastrointestinal bleeding
  • Anemia

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
haemoglobin
Time Frame: 13 weeks
13 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life Health economics
Time Frame: 13 weeks, 6 and 12 months
13 weeks, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

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

Investigators

  • Study Chair: Hendrik Vilstrup, Professor, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

September 16, 2009

First Submitted That Met QC Criteria

September 16, 2009

First Posted (Estimate)

September 17, 2009

Study Record Updates

Last Update Posted (Estimate)

April 5, 2013

Last Update Submitted That Met QC Criteria

April 4, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Iron Gab

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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