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Trial Comparing the Safety of Two Different Intravenous Iron Formulations

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

Status
Suspended
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00593619
Enrollment
200
Registered
2008-01-15
Start date
2008-01-31
Completion date
2009-12-31
Last updated
2009-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency Anemia, Perioperative Blood Conservation

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

DRUGIron sucrose

300mg in 250cc normal saline given over 2 hours

Sponsors

London Health Sciences Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frame
Incidence of severe adverse drug reactions (ADRs)Immediate - during infusion

Secondary

MeasureTime frame
Incidence of anaphylactic/anaphylactoid ADRsImmediate - during infusion
Incidence of combined mild and moderate ADRsImmediate - during infusion
Incidence of delayed ADRsdelayed - 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 ADRsImmediate and delayed - within 24hrs post infusion
Response in laboratory parametersWithin 1 month
Cost effectivenessCompletion of study
Incidence of all-cause mortalityImmediate and delayed - within 24hrs post infusion

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026