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

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Charite Universitatsmedizin Berlin
  • Muenster, Germany, D-48149
    • University Hospital Muenster

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: NaCl 0.9%	Drug: NaCl 0.9%; iv administration of max. 50 ml in 30 minutes
Experimental: Ferinject	Drug: Ferinject 50 mg/ml; iv administration of max. 50 ml (Dilution: 20 ml in 30 ml NaCl 0.9%) in 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of RBC units	Until postoperative day 7

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Collaborators: Vifor Pharma
• Investigators: Principal Investigator: Hugo K Van Aken, PhD, MD, Department of Anesthesia and Intensiv Care, University Hospital Muenster

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: April 21, 2011
• First Submitted That Met QC Criteria: April 29, 2011
• First Posted (Estimate): May 2, 2011

Study Record Updates

• Last Update Posted (Estimate): August 9, 2013
• Last Update Submitted That Met QC Criteria: August 7, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: anemia; transfusion; intravenous ferric carboxymaltose
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: UKM10_0027; 2010-024115-14 (EudraCT Number); 05-AnIt-09 (Other Identifier: Department of Anesthesiology and Intensive Care, University Hospital Muenster)