Trial Comparing the Safety of Two Different Intravenous Iron Formulations

NCT ID: NCT00593619

Last Updated: 2009-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-12-31

Brief Summary

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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

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Conditions

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Iron Deficiency Anemia Perioperative Blood Conservation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Iron Dextran

Group Type ACTIVE_COMPARATOR

Iron dextran

Intervention Type DRUG

300mg in 250cc normal saline given over 2 hours

Iron Sucrose

Group Type ACTIVE_COMPARATOR

Iron sucrose

Intervention Type DRUG

300mg in 250cc normal saline given over 2 hours

Interventions

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Iron dextran

300mg in 250cc normal saline given over 2 hours

Intervention Type DRUG

Iron sucrose

300mg in 250cc normal saline given over 2 hours

Intervention Type DRUG

Other Intervention Names

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Infufer, Sandoz Canada Incorporated, DIN 02221780 Venofer, Luitpold Pharmaceuticals Inc., DIN 02243716

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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London Health Sciences Centre

Principal Investigators

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Ian H Chin-Yee, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre

Fiona E Ralley, MB ChB, FRCA

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre

Cyrus C Hsia, MD,FRCPC

Role: STUDY_DIRECTOR

London Health Sciences Centre

Locations

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London Health Sciences Centre

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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HSREB13767

Identifier Type: -

Identifier Source: org_study_id

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