Iron Deficiency Anemia, Perioperative Blood Conservation
Conditions
Keywords
Intravenous Iron, Safety, Perioperative, Iron deficiency, Non hemodialysis population, Perioperative blood conservation
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.
Interventions
300mg in 250cc normal saline given over 2 hours
300mg in 250cc normal saline given over 2 hours
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of severe adverse drug reactions (ADRs) | Immediate - during infusion |
Secondary
| Measure | Time frame |
|---|---|
| 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 serious adverse drug reactions (ADRs) | 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 |
| Incidence of all-cause mortality | Immediate and delayed - within 24hrs post infusion |
Countries
Canada