Trial Comparing the Safety of Two Different Intravenous Iron Formulations

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Double-Blind Safety Comparison of Intravenous Iron Dextran Versus Iron Sucrose in an Adult Non-Hemodialysis Outpatient Population: A Pilot Study

Conditions
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Iron Deficiency Anemia, Perioperative Blood Conservation

Intervention / Treatment
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* Drug: Iron dextran
* Drug: Iron sucrose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Iron Dextran<br> | Drug: Iron dextran<br>* 300mg in 250cc normal saline given over 2 hours<br>* Other names: Infufer, Sandoz Canada Incorporated, DIN 02221780;|
| Active Comparator: Iron Sucrose<br> | Drug: Iron sucrose<br>* 300mg in 250cc normal saline given over 2 hours<br>* Other names: Venofer, Luitpold Pharmaceuticals Inc., DIN 02243716;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of severe adverse drug reactions (ADRs) |  | Immediate - during infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious adverse drug reactions (ADRs) |  | Immediate and delayed - within 24hrs post infusion | 
| Incidence of anaphylactic/anaphylactoid ADRs |  | Immediate - during infusion | 
| Incidence of combined mild and moderate ADRs |  | Immediate - during infusion | 
| Incidence of delayed ADRs |  | delayed - within 24hrs post infusion | 
| Incidence of all-cause mortality |  | Immediate and delayed - within 24hrs post infusion | 
| Physician and nursing time required to manage ADRs |  | Immediate and delayed - within 24hrs post infusion | 
| Response in laboratory parameters |  | Within 1 month | 
| Cost effectiveness |  | Completion of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intravenous Iron, Safety, Perioperative, Iron deficiency, Non hemodialysis population, Perioperative blood conservation