Intravenous Ferric Carboxymaltose (Ferinject) in Patients Undergoing Orthopaedic Surgery (PRIVIRON)

University Hospital Muenster

Status and phase: Terminated; Phase 4

Conditions: Anemia; Orthopedic Surgery; High Risk of Blood Loss

Treatments: Drug: Ferinject 50 mg/ml; Drug: NaCl 0.9%

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01345968

2010-024115-14 (EudraCT Number)

05-AnIt-09 (Other Identifier)

UKM10_0027

Details and patient eligibility

About

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

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3 participants in 2 patient groups, including a placebo group

NaCl 0.9%

Placebo Comparator group

Treatment:

Drug: NaCl 0.9%

Ferinject

Experimental group

Treatment:

Drug: Ferinject 50 mg/ml