Trial Comparing the Safety of Two Different Intravenous Iron Formulations

London Health Sciences Centre

Status and phase: Suspended; Phase 4

Conditions: Iron Deficiency Anemia; Perioperative Blood Conservation

Treatments: Drug: Iron dextran; Drug: Iron sucrose

Study type: Interventional

Funder types: Other

Identifiers

NCT00593619

HSREB13767

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Iron Dextran

Active Comparator group

Treatment:

Drug: Iron dextran

Iron Sucrose

Active Comparator group

Treatment:

Drug: Iron sucrose