Iron Substitution After Upper Gastro-Intestinal Bleeding
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
1 other identifier
interventional
97
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2010
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2009
CompletedFirst Posted
Study publicly available on registry
September 17, 2009
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedApril 5, 2013
April 1, 2013
2.8 years
September 16, 2009
April 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
haemoglobin
13 weeks
Secondary Outcomes (1)
Quality of life Health economics
13 weeks, 6 and 12 months
Study Arms (3)
Intravenous iron
ACTIVE COMPARATOROral iron
ACTIVE COMPARATORIsotonic Sodium and placebo tablets
PLACEBO COMPARATORInterventions
Single dose of maximum 1000 mg ferricarboxymaltose intravenous
Eligibility Criteria
You may qualify if:
- Acute upper gastrointestinal bleeding
- Anemia
You may not qualify if:
- Liver disease
- Terminal cancer
- Kidney disease
- variceal bleeding
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- GCP-unit at Aarhus University Hospital, Aarhus, Denmarkcollaborator
- Vifor Pharmacollaborator
Study Sites (1)
Aarhus University Hospital
Aarhus, Aarhus, 8000, Denmark
Related Publications (1)
Bager P, Dahlerup JF. Randomised clinical trial: oral vs. intravenous iron after upper gastrointestinal haemorrhage--a placebo-controlled study. Aliment Pharmacol Ther. 2014 Jan;39(2):176-87. doi: 10.1111/apt.12556. Epub 2013 Nov 19.
PMID: 24251969DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hendrik Vilstrup, Professor
Aarhus University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Nurse Specialist, RN, MPH
Study Record Dates
First Submitted
September 16, 2009
First Posted
September 17, 2009
Study Start
April 1, 2010
Primary Completion
January 1, 2013
Study Completion
April 1, 2013
Last Updated
April 5, 2013
Record last verified: 2013-04