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

This study has been terminated.
(Less patients than expected for inclusion, therefore recruitment is too low)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01345968
First Posted: May 2, 2011
Last Update Posted: August 9, 2013
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.
Collaborator:
Vifor Pharma
Information provided by (Responsible Party):
University Hospital Muenster
  Purpose
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 Intervention Phase
Anemia Orthopedic Surgery High Risk of Blood Loss Drug: Ferinject 50 mg/ml Drug: NaCl 0.9% Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

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

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

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

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

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

Enrollment: 3
Study Start Date: June 2011
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01345968


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

Responsible Party: University Hospital Muenster
ClinicalTrials.gov 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 Submitted: April 21, 2011
First Posted: May 2, 2011
Last Update Posted: August 9, 2013
Last Verified: July 2013

Keywords provided by University Hospital Muenster:
anemia
transfusion
intravenous ferric carboxymaltose

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Ferric Compounds
Hematinics