Status:
TERMINATED
Intravenous Ferric Carboxymaltose (Ferinject®) With or Without Erythropoietin in Patients Undergoing Orthopaedic Surgery
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
Vifor Pharma
Conditions:
Iron Deficiency Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Study Design: Single-centre, block randomised, blinded, controlled, phase IIIb, parallel group pilot study. Primary Objective: • To evaluate the effect of the administration of ferric carboxymaltose...
Detailed Description
TREATMENT: Patients will be randomised 1:1:1 to one of the following groups: Group I - Ferinject ® and EPO treatment group 25 patients will be randomised to the Ferinject and EPO treatment group. F...
Eligibility Criteria
Inclusion
- \> 18 years of age and signed written informed consent
- Patients scheduled to undergo major orthopaedic surgery (hip or knee arthroplasty or back surgery)
- 10 g/dl \< Hb \< 13.0 g/dl for men and 10 g/dl \< Hb \< 12.0 g/dl for women, at screening ( 3 weeks prior to surgery)
- Ferritin \< 100 μg/l or 100-300 with TSat \< 20%
Exclusion
- Suspicion of iron overload (Ferritin \>300 μg/l or/and TSAT\>50%)
- Active severe infection/inflammation (defined as serum CRP \> 20 mg/l) or diagnosed malignancy
- Folate-and/or Vitamin B12 deficiency (according to local lab reference range)
- Known history of hepatitis B/C or HIV-positive
- Liver values 3 times higher than normal
- Immunosuppressive or myelosuppressive therapy
- A concurrent medical condition(s) that, in the view of the investigator, would prevent compliance or participation or jeopardize the health of the patients.
- Pregnancy or lactation
- Transfusion within 1 month prior to study inclusion, EPO treatment with in the last 4 weeks, any iron treatment within 4 weeks prior to the inclusion in the trail
- Participation in any other therapeutic trial within the previous month
- History of thromboembolic events in the family or the patient
- Severe peripheral, coronary or carotid artery disease
- Bodyweight \< 50 kg
- Patients not able to understand the German language
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00706667
Start Date
May 1 2008
End Date
December 1 2012
Last Update
June 20 2013
Active Locations (1)
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1
University Hospital Zurich, Division of Anaesthesiology
Zurich, Canton of Zurich, Switzerland, 8091