Intravenous Ferric Carboxymaltose (Ferinject®) With or Without Erythropoietin in Patients Undergoing Orthopaedic Surgery
Status:
Terminated
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
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.