Trial Comparing the Safety of Two Different Intravenous Iron Formulations - Full Text View

Sponsored by:	London Health Sciences Centre
Information provided by:	London Health Sciences Centre
ClinicalTrials.gov Identifier:	NCT00593619

Purpose

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.

Condition	Intervention	Phase
Iron Deficiency	Drug: Iron dextran Drug: Iron sucrose	Phase IV

Drug Information available for: Sucrose Dextrans Ferric oxide, saccharated Iron-dextran complex

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Safety Study
Official Title:	A Randomized Double-Blind Safety Comparison of Intravenous Iron Dextran Versus Iron Sucrose in an Adult Non-Hemodialysis Outpatient Population: A Pilot Study

Further study details as provided by London Health Sciences Centre:

Primary Outcome Measures:

Incidence of severe adverse drug reactions (ADRs) [ Time Frame: Immediate ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence of serious adverse drug reactions (ADRs) [ Time Frame: Immediate and delayed ] [ Designated as safety issue: Yes ]
Incidence of anaphylactic/anaphylactoid ADRs [ Time Frame: Immediate ] [ Designated as safety issue: Yes ]
Incidence of combined mild and moderate ADRs [ Time Frame: Immediate ] [ Designated as safety issue: Yes ]
Incidence of delayed ADRs [ Time Frame: delayed ] [ Designated as safety issue: Yes ]
Incidence of all-cause mortality [ Time Frame: Immediate and delayed ] [ Designated as safety issue: Yes ]
Physician and nursing time required to manage ADRs [ Time Frame: Immediate and delayed ] [ Designated as safety issue: Yes ]
Response in laboratory parameters [ Time Frame: Within 1 month ] [ Designated as safety issue: No ]
Cost effectiveness [ Time Frame: Completion of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Iron Dextran: Active Comparator	Drug: Iron dextran 300mg in 250cc normal saline given over 2 hours
Iron Sucrose: Active Comparator	Drug: Iron sucrose 300mg in 250cc normal saline given over 2 hours

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593619

Contacts

Contact: Cyrus C Hsia, MD, FRCPC	519-685-8500 ext 19893	cchsia@uwo.ca
Contact: Ian H Chin-Yee, MD, FRCPC	519-685-8500 ext 14330	ian.chinyee@lhsc.on.ca

Locations

Canada, Ontario
London Health Sciences Centre	Recruiting
London, Ontario, Canada, N6A 5W9
Principal Investigator: Ian H Chin-Yee, MD, FRCPC
Principal Investigator: Fiona E Ralley, MB ChB, FRCA
Sub-Investigator: Cyrus C Hsia, MD, FRCPC
Sub-Investigator: Janet Martin, MSc, PharmD
Sub-Investigator: Sarah Connelly, BScPhm, MSc
Sub-Investigator: Donna Berta, RN, BScN
Sub-Investigator: Valerie Binns, RN, BScN

Sponsors and Collaborators

London Health Sciences Centre

Investigators

Principal Investigator:	Ian H Chin-Yee, MD, FRCPC	London Health Sciences Centre
Principal Investigator:	Fiona E Ralley, MB ChB, FRCA	London Health Sciences Centre
Study Director:	Cyrus C Hsia, MD,FRCPC	London Health Sciences Centre

More Information

Responsible Party:	London Health Sciences Centre ( Ian H. Chin-Yee, Chair/Chief of Hematology )
Study ID Numbers:	HSREB13767
Study First Received:	January 3, 2008
Last Updated:	January 14, 2008
ClinicalTrials.gov Identifier:	NCT00593619
Health Authority:	Canada: Ethics Review Committee

Keywords provided by London Health Sciences Centre:

Intravenous Iron
Safety
Perioperative

Iron deficiency
Non hemodialysis population
Perioperative blood conservation

Study placed in the following topic categories:

Iron-Dextran Complex
Ferric oxide, saccharated
Metabolic Diseases
Hematologic Diseases
Anemia

Iron Metabolism Disorders
Metabolic disorder
Iron
Dextrans
Anemia, Iron-Deficiency

Additional relevant MeSH terms:

Anticoagulants
Hematinics
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Blood Substitutes

Hematologic Agents
Anemia, Hypochromic
Trace Elements
Micronutrients
Plasma Substitutes
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009