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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01345968
Recruitment Status : Terminated (Less patients than expected for inclusion, therefore recruitment is too low)
First Posted : May 2, 2011
Last Update Posted : August 9, 2013
Vifor Pharma
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Anemia Orthopedic Surgery High Risk of Blood Loss Drug: Ferinject 50 mg/ml Drug: NaCl 0.9% Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preoperative Intravenous Ferric Carboxymaltose (Ferinject) in Patients With Orthopedic Surgery and High Risk of Blood Loss
Study Start Date : June 2011
Primary Completion Date : January 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Number of RBC units [ Time Frame: Until postoperative day 7 ]

Secondary Outcome Measures :
  1. Blood transfusion rate [ Time Frame: Until postoperative day 7 ]
    Number of patients with blood transfusions

  2. Frequency of postoperative complications [ Time Frame: Until postoperative day 7 ]
    Number of postoperative complications from baseline until postoperative day 7

  3. Frequency of postoperative complications [ Time Frame: Until 6 weeks after surgical intervention ]
    Number of postoperative complication from baseline until 6 weeks after surgical intervention

  4. Length of hospital stay [ Time Frame: 6 weeks after surgical intervention ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01345968

Charité Universitätsmedizin Berlin
Berlin, Germany
University Hospital Muenster
Muenster, Germany, D-48149
Sponsors and Collaborators
University Hospital Muenster
Vifor Pharma
Principal Investigator: Hugo K Van Aken, PhD, MD Department of Anesthesia and Intensiv Care, University Hospital Muenster

Responsible Party: University Hospital Muenster Identifier: NCT01345968     History of Changes
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 )
First Posted: May 2, 2011    Key Record Dates
Last Update Posted: August 9, 2013
Last Verified: July 2013

Keywords provided by University Hospital Muenster:
intravenous ferric carboxymaltose

Additional relevant MeSH terms:
Pathologic Processes
Ferric Compounds