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Iron Substitution After Upper Gastro-Intestinal Bleeding

Primary Purpose

Gastrointestinal Hemorrhage, Anemia

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
ferricarboxymaltose
Ferrosulfate
Placebo
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Hemorrhage focused on measuring Iron treatment, Upper gastrointestinal bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Acute upper gastrointestinal bleeding
  • Anemia

Exclusion Criteria:

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

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Intravenous iron

Oral iron

Isotonic Sodium and placebo tablets

Arm Description

Outcomes

Primary Outcome Measures

haemoglobin

Secondary Outcome Measures

Quality of life Health economics

Full Information

First Posted
September 16, 2009
Last Updated
April 4, 2013
Sponsor
University of Aarhus
Collaborators
GCP-unit at Aarhus University Hospital, Aarhus, Denmark, Vifor Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00978575
Brief Title
Iron Substitution After Upper Gastro-Intestinal Bleeding
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 Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
Collaborators
GCP-unit at Aarhus University Hospital, Aarhus, Denmark, Vifor Pharma

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Hemorrhage, Anemia
Keywords
Iron treatment, Upper gastrointestinal bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous iron
Arm Type
Active Comparator
Arm Title
Oral iron
Arm Type
Active Comparator
Arm Title
Isotonic Sodium and placebo tablets
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ferricarboxymaltose
Other Intervention Name(s)
Ferinject
Intervention Description
Single dose of maximum 1000 mg ferricarboxymaltose intravenous
Intervention Type
Drug
Intervention Name(s)
Ferrosulfate
Other Intervention Name(s)
FerroDuretter
Intervention Description
200mg daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
100 mg isotonic sodium and 2 placebo tablets daily
Primary Outcome Measure Information:
Title
haemoglobin
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Quality of life Health economics
Time Frame
13 weeks, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute upper gastrointestinal bleeding Anemia Exclusion Criteria: Liver disease Terminal cancer Kidney disease variceal bleeding Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hendrik Vilstrup, Professor
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
24251969
Citation
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.
Results Reference
derived

Learn more about this trial

Iron Substitution After Upper Gastro-Intestinal Bleeding

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