Overview

Effect of Postoperative Ferric Carboxymaltose

Status:
Unknown status
Trial end date:
2019-12-11
Target enrollment:
0
Participant gender:
All
Summary
The primary purpose of this study is to evaluate the safety and efficacy of postoperative intravenous ferric carboxymaltose in patients with anemia undergoing Simultaneous Bilateral Total knee replacement in terms of Quality of life (QOL) and objective measures (Hemoglobin and Iron parameters).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Catholic University of Korea
Treatments:
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)

- Hb < 10.0 g/dl after operation

- Ferritin < 100 μg/l or 100-300 with transferrin saturation < 20%

Exclusion Criteria:

- Suspicion of iron overload (Ferritin >300 μg/l or/and transferrin saturation>50%)

- Active severe infection/inflammation (defined as serum C reactive protein > 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, erythropoietin 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