Intravenous Ferric Carboxymaltose (Ferinject) in Patients Undergoing Orthopaedic Surgery

• Status: Terminated
• Trial end date: 2013-02-01
• 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 hip or knee replacement

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Muenster
• Collaborator: Vifor Pharma
• Treatments: Ferric Compounds

Criteria

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