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Iron Substitution After Upper Gastro-Intestinal Bleeding

Sponsor
University of Aarhus (Other)
Overall Status
Completed
CT.gov ID
NCT00978575
Collaborator
GCP-unit at Aarhus University Hospital, Aarhus, Denmark (Other), Vifor Pharma (Industry)
97
Enrollment
1
Location
3
Arms
36
Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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
Phase 4

Study Design

Study Type:
Interventional
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 :
Apr 1, 2010
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Apr 1, 2013

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. haemoglobin [13 weeks]

    Secondary Outcome Measures

    1. Quality of life Health economics [13 weeks, 6 and 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aarhus University Hospital Aarhus Denmark 8000

    Sponsors and Collaborators

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

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Palle Bager, Clinical Nurse Specialist, RN, MPH, University of Aarhus
    ClinicalTrials.gov Identifier:
    NCT00978575
    Other Study ID Numbers:
    • Iron Gab
    First Posted:
    Sep 17, 2009
    Last Update Posted:
    Apr 5, 2013
    Last Verified:
    Apr 1, 2013
    Keywords provided by Palle Bager, Clinical Nurse Specialist, RN, MPH, University of Aarhus
    Iron treatment
    Upper gastrointestinal bleeding
    Additional relevant MeSH terms:
    Gastrointestinal Hemorrhage
    Hemorrhage

    Study Results

    No Results Posted as of Apr 5, 2013