Intravenous ferric carboxymaltose (Ferinject®) with or without Erythropoietin for the correction of preoperative anaemia in patients undergoing orthopaedic surgery
- Conditions
- •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 •To gain informations for the design of a possible follow-up study•.•To evaluate the tolerability and safety of Ferinject®
- Registration Number
- EUCTR2009-015799-92-AT
- Lead Sponsor
- niversitätspital Zürich Anästhesie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 75
•> 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%
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main 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 ;Primary end point(s): •Hb increase from baseline till day of surgery;Secondary Objective: •To gain informations for the design of a possible follow-up study<br>•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.<br>•To evaluate the tolerability and safety of Ferinject<br>
- Secondary Outcome Measures
Name Time Method