Intravenous Ferric Carboxymaltose (Ferinject) in Patients Undergoing Orthopaedic Surgery
NCT ID: NCT01345968
Last Updated: 2013-08-09
Study Results
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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TERMINATED
PHASE4
3 participants
INTERVENTIONAL
2011-06-30
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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NaCl 0.9%
NaCl 0.9%
iv administration of max. 50 ml in 30 minutes
Ferinject
Ferinject 50 mg/ml
iv administration of max. 50 ml (Dilution: 20 ml in 30 ml NaCl 0.9%) in 30 minutes
Interventions
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Ferinject 50 mg/ml
iv administration of max. 50 ml (Dilution: 20 ml in 30 ml NaCl 0.9%) in 30 minutes
NaCl 0.9%
iv administration of max. 50 ml in 30 minutes
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Vifor Pharma
INDUSTRY
University Hospital Muenster
OTHER
Responsible Party
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Principal Investigators
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Hugo K Van Aken, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesia and Intensiv Care, University Hospital Muenster
Locations
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Charité Universitätsmedizin Berlin
Berlin, , Germany
University Hospital Muenster
Münster, , Germany
Countries
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Other Identifiers
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2010-024115-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
05-AnIt-09
Identifier Type: OTHER
Identifier Source: secondary_id
UKM10_0027
Identifier Type: -
Identifier Source: org_study_id