Intravenous Ferric Carboxymaltose (Ferinject) in Patients Undergoing Orthopaedic Surgery

Preoperative Intravenous Ferric Carboxymaltose (Ferinject) in Patients With Orthopedic Surgery and High Risk of Blood Loss

The primary purpose of this study is to evaluate the safety and efficacy of preoperative intravenous ferric carboxymaltose in patients with anemia undergoing hip or knee replacement

Inclusion Criteria:

• age >= 18 years
• Patients scheduled to undergo hip or knee replacement
• 8 g/dl < Hb < 13 g/dl for men and 8 g/dl < Hb < 12 g/dl for women at screening (3-4 weeks prior to surgery)
• anemia
• signed written informed consent

Exclusion Criteria:

• immunosuppressive or myelosuppressive therapy
• history of thromboembolic events
• a concurrent medical condition(s) that would prevent compliance or participation or jeopardize the health of the patient
• hypersensitivity to any component of the formulation
• transfusion within 1 month prior to study inclusion
• liver values 3 times higher than normal
• active severe infection/inflammation
• renal insufficiency