Intravenous ferric carboxymaltose (Ferinject®) with or without Erythropoietin for the correction of preoperative anaemia in patients undergoing orthopaedic surgery

niversitätspital Zürich Anästhesie0 个研究点目标入组 75 人开始时间: 2009年10月14日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•> 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

发起方

niversitätspital Zürich Anästhesie