NCT00593619

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: London Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Iron Deficiency Anemia
• Perioperative Blood Conservation

Interventions

Type	Name	Description
DRUG	Iron dextran	300mg in 250cc normal saline given over 2 hours
DRUG	Iron sucrose	300mg in 250cc normal saline given over 2 hours

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2008-01-15
• Last updated: 2009-03-03

Locations

1 site across 1 country: Canada