Trial Comparing the Safety of Two Different Intravenous Iron Formulations

Phase 4

Suspended

• Conditions: Iron Deficiency Anemia; Perioperative Blood Conservation
• Interventions: Drug: Iron sucrose; Drug: Iron dextran

• Registration Number: NCT00593619
• Lead Sponsor: London Health Sciences Centre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-03
• Study First Submitted QC: 2008-01-14
• Study First Posted: 2008-01-15
• Status Verified: 2009-02
• Last Update Submitted: 2009-03-02
• Last Update Posted: 2009-03-03
• Primary Completion: 2009-12
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iron Sucrose	Iron sucrose	-
Iron Dextran	Iron dextran	-

Primary Outcome Measures

Name	Time	Method
Incidence of severe adverse drug reactions (ADRs)	Immediate - during infusion

Secondary Outcome Measures

Name	Time	Method
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
Incidence of serious adverse drug reactions (ADRs)	Immediate and delayed - within 24hrs post infusion
Incidence of anaphylactic/anaphylactoid ADRs	Immediate - during infusion

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada