Intravenous Ferric Carboxymaltose (Ferinject) in Patients Undergoing Orthopaedic Surgery

NCT ID: NCT01345968

Last Updated: 2013-08-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-02-28

Brief 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

Conditions

Anemia; Orthopedic Surgery; High Risk of Blood Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

NaCl 0.9%

Group Type: PLACEBO_COMPARATOR

NaCl 0.9%

Intervention Type: DRUG

iv administration of max. 50 ml in 30 minutes

Ferinject

Group Type: EXPERIMENTAL

Ferinject 50 mg/ml

Intervention Type: DRUG

iv administration of max. 50 ml (Dilution: 20 ml in 30 ml NaCl 0.9%) in 30 minutes

Interventions

Ferinject 50 mg/ml

iv administration of max. 50 ml (Dilution: 20 ml in 30 ml NaCl 0.9%) in 30 minutes

Intervention Type: DRUG

NaCl 0.9%

iv administration of max. 50 ml in 30 minutes

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vifor Pharma

INDUSTRY

Sponsor Role: collaborator

University Hospital Muenster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hugo K Van Aken, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia and Intensiv Care, University Hospital Muenster

Locations

Charité Universitätsmedizin Berlin

Berlin, , Germany

University Hospital Muenster

Münster, , Germany

Countries

Germany

Other Identifiers

2010-024115-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

05-AnIt-09

Identifier Type: OTHER

Identifier Source: secondary_id

UKM10_0027

Identifier Type: -

Identifier Source: org_study_id