Iron Substitution After Upper Gastro-Intestinal Bleeding

This study has been completed.
Sponsor:
Collaborators:
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
Vifor Pharma
Information provided by (Responsible Party):
Palle Bager, University of Aarhus
ClinicalTrials.gov Identifier:
NCT00978575
First received: September 16, 2009
Last updated: April 4, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Gastrointestinal Hemorrhage
Anemia
Drug: ferricarboxymaltose
Drug: Ferrosulfate
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • haemoglobin [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life Health economics [ Time Frame: 13 weeks, 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 97
Study Start Date: April 2010
Study Completion Date: April 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute upper gastrointestinal bleeding
  • Anemia

Exclusion Criteria:

  • Liver disease
  • Terminal cancer
  • Kidney disease
  • variceal bleeding
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00978575

Locations
Denmark
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
  More Information

No publications provided by University of Aarhus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Palle Bager, Clinical Nurse Specialist, RN, MPH, University of Aarhus
ClinicalTrials.gov Identifier: NCT00978575     History of Changes
Other Study ID Numbers: Iron Gab
Study First Received: September 16, 2009
Last Updated: April 4, 2013
Health Authority: Denmark: Danish Medicines Agency

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

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

ClinicalTrials.gov processed this record on October 01, 2014