Intravenous Ferric Carboxymaltose (Ferinject) in Patients... | NCT01345968

Studies
Intravenous Ferric Carboxymaltose (Ferinject) in Patients Undergoing Orthopaedic Surgery

NCT01345968

Sponsor

University Hospital Muenster

Status

Terminated

Last Update Posted

Aug 9, 2013Estimated

Enrollment

3Actual

Phase

Phase 4

Conditions

Anemia
Orthopedic Surgery
High Risk of Blood Loss

Interventions

Ferinject 50 mg/ml
NaCl 0.9%

Countries

Germany

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

ID	Type	Description	Link
2010-024115-14	EudraCT Number
05-AnIt-09	Other Identifier	Department of Anesthesiology and Intensive Care, University Hospital Muenster

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Less patients than expected for inclusion, therefore recruitment is too low

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Jan 2013Actual

Completion Date

Feb 2013Actual

First Submitted Date

Apr 21, 2011

First Submission Date that Met QC Criteria

Apr 29, 2011

First Posted Date

May 2, 2011Estimated

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

Aug 7, 2013

Last Update Posted Date

Aug 9, 2013Estimated

Name	Class
Vifor Pharma	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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 primary purpose of this study is to evaluate the safety and efficacy of preoperative intravenous ferric carboxymaltose in patients with anemia undergoing hip or knee replacement

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

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NaCl 0.9%	Placebo Comparator		Drug: NaCl 0.9%
Ferinject	Experimental		Drug: Ferinject 50 mg/ml

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ferinject 50 mg/ml	Drug	iv administration of max. 50 ml (Dilution: 20 ml in 30 ml NaCl 0.9%) in 30 minutes	Ferinject

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of RBC units		Until postoperative day 7

Secondary Outcomes

Measure	Description	Time Frame
Blood transfusion rate	Number of patients with blood transfusions	Until postoperative day 7
Frequency of postoperative complications	Number of postoperative complications from baseline until postoperative day 7

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age >= 18 years
Patients scheduled to undergo hip or knee replacement
8 g/dl < Hb < 13 g/dl for men and 8 g/dl < Hb < 12 g/dl for women at screening (3-4 weeks prior to surgery)
anemia
signed written informed consent

Exclusion Criteria:

immunosuppressive or myelosuppressive therapy
history of thromboembolic events
a concurrent medical condition(s) that would prevent compliance or participation or jeopardize the health of the patient
hypersensitivity to any component of the formulation
transfusion within 1 month prior to study inclusion
liver values 3 times higher than normal
active severe infection/inflammation
renal insufficiency

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
Hugo K Van Aken, PhD, MD	Department of Anesthesia and Intensiv Care, University Hospital Muenster	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité Universitätsmedizin Berlin		Berlin			Germany
University Hospital Muenster

Condition Browse Module

MeSH Terms

ID	Term
D000740	Anemia

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C522335	ferric carboxymaltose
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided