Intravenous Ferric Carboxymaltose (Ferinject®) With or Without Erythropoietin in Patients Undergoing Orthopaedic Surgery

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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 (Ferinject®) with or without erythropoietin vs. no treatment (standard therapy) on the preoperative anaemia status in patients undergoing orthopaedic surgery

Secondary Objective:

• To gain informations for the design of a possible follow-up study

• To evaluate the effect of the administration of ferric carboxymaltose (Ferinject®) with or without erythropoietin vs. no treatment (standard therapy) on pre- and postoperative Hb levels, iron status, transfusion rate, days until discharge.

• To evaluate the tolerability and safety of Ferinject®

Study Centres:

This is a single centre study

Patients:

A total of 75 completed patients (50 patients in the intravenous iron treatment groups and 25 patients in the no treatment group will be recruited.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich
• Collaborators: Vifor Inc.; Vifor Pharma
• Treatments: Epoetin Alfa; Ferric Compounds

Criteria

Inclusion Criteria:

• > 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 Criteria:

• 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