Trial Comparing the Safety of Two Different Intravenous I... | NCT00593619

Studies
Trial Comparing the Safety of Two Different Intravenous Iron Formulations

NCT00593619

Sponsor

London Health Sciences Centre

Status

Suspended

Last Update Posted

Mar 3, 2009Estimated

Enrollment

200Estimated

Phase

Phase 4

Conditions

Iron Deficiency Anemia
Perioperative Blood Conservation

Interventions

Iron dextran
Iron sucrose

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Interim Analysis and review by Data Safety Monitoring Board

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Dec 2009Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

Jan 3, 2008

First Submission Date that Met QC Criteria

Jan 14, 2008

First Posted Date

Jan 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2009

Last Update Posted Date

Mar 3, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Iron Dextran	Active Comparator		Drug: Iron dextran
Iron Sucrose	Active Comparator		Drug: Iron sucrose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Iron dextran	Drug	300mg in 250cc normal saline given over 2 hours	Iron Dextran

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of severe adverse drug reactions (ADRs)		Immediate - during infusion

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
London Health Sciences Centre		London	Ontario	N6A 5W9	Canada

Condition Browse Module

MeSH Terms

ID	Term
D018798	Anemia, Iron-Deficiency
D000090463	Iron Deficiencies

Ancestor Terms

ID	Term
D000747	Anemia, Hypochromic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007505	Iron-Dextran Complex
D000077605	Ferric Oxide, Saccharated

Ancestor Terms

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D003911	Dextrans
D005936	Glucans

Browse Leaves

Not provided

Browse Branches

Not provided