Effect of Preoperative Ferric Carboxymaltose After Simultaneous Bilateral Total Knee Arthroplasty

• 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 preoperative intravenous ferric carboxymaltose in patients with anemia undergoing Simultaneous Bilateral Total knee replacement in terms of Quality of life (QOL) and objective measures (Hb 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 < 13.0 g/dl for men and Hb < 12.0 g/dl for women, at screening ( 3 weeks prior to surgery)

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

Exclusion Criteria:

• Suspicion of iron overload (Ferritin >300 μg/l or/andtransferrin 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