NCT00593619

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 3, 2009

Status Verified

February 1, 2009

Enrollment Period

1.9 years

First QC Date

January 3, 2008

Last Update Submit

March 2, 2009

Conditions

Iron Deficiency AnemiaPerioperative Blood Conservation

Keywords

Intravenous IronSafetyPerioperativeIron deficiencyNon hemodialysis populationPerioperative blood conservation

Outcome Measures

Primary Outcomes (1)

  • Incidence of severe adverse drug reactions (ADRs)

    Immediate - during infusion

Secondary Outcomes (8)

  • Incidence of serious adverse drug reactions (ADRs)

    Immediate and delayed - within 24hrs post infusion

  • Incidence of anaphylactic/anaphylactoid ADRs

    Immediate - during infusion

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Iron Dextran

ACTIVE COMPARATOR
Drug: Iron dextran

Iron Sucrose

ACTIVE COMPARATOR
Drug: Iron sucrose

Interventions

Iron dextranDRUG

300mg in 250cc normal saline given over 2 hours

Also known as: Infufer, Sandoz Canada Incorporated, DIN 02221780
Iron Dextran
Iron sucroseDRUG

300mg in 250cc normal saline given over 2 hours

Also known as: Venofer, Luitpold Pharmaceuticals Inc., DIN 02243716
Iron Sucrose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 100
  • To be receiving intravenous iron

You may not qualify if:

  • Age \< 18
  • Hemodialysis
  • Previous exposure to intravenous iron
  • Unable to provide written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Anemia, Iron-DeficiencyIron Deficiencies

Interventions

Iron-Dextran ComplexFerric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDextransGlucansPolysaccharidesCarbohydratesFerric CompoundsIron CompoundsInorganic ChemicalsGlucaric AcidSugar AcidsAcids, AcyclicCarboxylic AcidsHydroxy Acids

Study Officials

  • Ian H Chin-Yee, MD, FRCPC

    London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

  • Fiona E Ralley, MB ChB, FRCA

    London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

  • Cyrus C Hsia, MD,FRCPC

    London Health Sciences Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2008

First Posted

January 15, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 3, 2009

Record last verified: 2009-02

Locations

CA(1)