Back to resultsTrial Comparing the Safety of Two Different Intravenous Iron Formulations
Primary Purpose
Iron Deficiency Anemia, Perioperative Blood Conservation
Status
Suspended
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Iron dextran
Iron sucrose
Sponsored by
About this trial
This is an interventional treatment trial for Iron Deficiency Anemia focused on measuring Intravenous Iron, Safety, Perioperative, Iron deficiency, Non hemodialysis population, Perioperative blood conservation
Eligibility Criteria
Inclusion Criteria:
- Age 18 to 100
- To be receiving intravenous iron
Exclusion Criteria:
- Age < 18
- Hemodialysis
- Previous exposure to intravenous iron
- Unable to provide written consent
Sites / Locations
- London Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Iron Dextran
Iron Sucrose
Arm Description
Outcomes
Primary Outcome Measures
Incidence of severe adverse drug reactions (ADRs)
Secondary Outcome Measures
Incidence of serious adverse drug reactions (ADRs)
Incidence of anaphylactic/anaphylactoid ADRs
Incidence of combined mild and moderate ADRs
Incidence of delayed ADRs
Incidence of all-cause mortality
Physician and nursing time required to manage ADRs
Response in laboratory parameters
Cost effectiveness
Full Information
NCT ID
NCT00593619
First Posted
January 3, 2008
Last Updated
March 2, 2009
Sponsor
London Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT00593619
Brief Title
Trial Comparing the Safety of Two Different Intravenous Iron Formulations
Official Title
A Randomized Double-Blind Safety Comparison of Intravenous Iron Dextran Versus Iron Sucrose in an Adult Non-Hemodialysis Outpatient Population: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Suspended
Why Stopped
Interim Analysis and review by Data Safety Monitoring Board
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
London Health Sciences Centre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this trial is to compare the safety profile using equal doses of intravenous iron dextran versus iron sucrose. The researchers hypothesize that significantly more patients receiving intravenous iron dextran (using the current intermediate molecular weight product) will have severe adverse outcomes than patients receiving iron sucrose in the adult non-hemodialysis outpatient population. Secondly, since these severe reactions may require additional nursing time and physician interventions that may negate any cost advantage of iron dextran, the researchers hypothesize that iron sucrose will be more cost-effective than iron dextran.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia, Perioperative Blood Conservation
Keywords
Intravenous Iron, Safety, Perioperative, Iron deficiency, Non hemodialysis population, Perioperative blood conservation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Iron Dextran
Arm Type
Active Comparator
Arm Title
Iron Sucrose
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Iron dextran
Other Intervention Name(s)
Infufer, Sandoz Canada Incorporated, DIN 02221780
Intervention Description
300mg in 250cc normal saline given over 2 hours
Intervention Type
Drug
Intervention Name(s)
Iron sucrose
Other Intervention Name(s)
Venofer, Luitpold Pharmaceuticals Inc., DIN 02243716
Intervention Description
300mg in 250cc normal saline given over 2 hours
Primary Outcome Measure Information:
Title
Incidence of severe adverse drug reactions (ADRs)
Time Frame
Immediate - during infusion
Secondary Outcome Measure Information:
Title
Incidence of serious adverse drug reactions (ADRs)
Time Frame
Immediate and delayed - within 24hrs post infusion
Title
Incidence of anaphylactic/anaphylactoid ADRs
Time Frame
Immediate - during infusion
Title
Incidence of combined mild and moderate ADRs
Time Frame
Immediate - during infusion
Title
Incidence of delayed ADRs
Time Frame
delayed - within 24hrs post infusion
Title
Incidence of all-cause mortality
Time Frame
Immediate and delayed - within 24hrs post infusion
Title
Physician and nursing time required to manage ADRs
Time Frame
Immediate and delayed - within 24hrs post infusion
Title
Response in laboratory parameters
Time Frame
Within 1 month
Title
Cost effectiveness
Time Frame
Completion of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 to 100
To be receiving intravenous iron
Exclusion Criteria:
Age < 18
Hemodialysis
Previous exposure to intravenous iron
Unable to provide written consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian H Chin-Yee, MD, FRCPC
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fiona E Ralley, MB ChB, FRCA
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cyrus C Hsia, MD,FRCPC
Organizational Affiliation
London Health Sciences Centre
Official's Role
Study Director
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Trial Comparing the Safety of Two Different Intravenous Iron Formulations
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