Intravenous Ferric Carboxymaltose (Ferinject) in Patients Undergoing Orthopaedic Surgery

Phase 4

Terminated

• Conditions: Anemia; Orthopedic Surgery; High Risk of Blood Loss
• Interventions: Drug: NaCl 0.9%; Drug: Ferinject 50 mg/ml

• Registration Number: NCT01345968
• Lead Sponsor: University Hospital Muenster

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-21
• Study First Submitted QC: 2011-04-29
• Study First Posted: 2011-05-02
• Study Start: 2011-06
• Primary Completion: 2013-01
• Study Completion: 2013-02
• Status Verified: 2013-07
• Last Update Submitted: 2013-08-07
• Last Update Posted: 2013-08-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NaCl 0.9%	NaCl 0.9%	-
Ferinject	Ferinject 50 mg/ml	-

Primary Outcome Measures

Name	Time	Method
Number of RBC units	Until postoperative day 7

Secondary Outcome Measures

Name	Time	Method
Blood transfusion rate	Until postoperative day 7	Number of patients with blood transfusions
Frequency of postoperative complications	Until 6 weeks after surgical intervention	Number of postoperative complication from baseline until 6 weeks after surgical intervention
Length of hospital stay	6 weeks after surgical intervention

Trial Locations

Locations (2)

University Hospital Muenster; 🇩🇪 Muenster, Germany

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany