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:
Collaborator:
Vifor Pharma
Information provided by (Responsible Party):
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT01345968
First received: April 21, 2011
Last updated: August 7, 2013
Last verified: July 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood transfusion rate [ Time Frame: Until postoperative day 7 ] [ Designated as safety issue: No ]
    Number of patients with blood transfusions

  • Frequency of postoperative complications [ Time Frame: Until postoperative day 7 ] [ Designated as safety issue: No ]
    Number of postoperative complications from baseline until postoperative day 7

  • Frequency of postoperative complications [ Time Frame: Until 6 weeks after surgical intervention ] [ Designated as safety issue: No ]
    Number of postoperative complication from baseline until 6 weeks after surgical intervention

  • Length of hospital stay [ Time Frame: 6 weeks after surgical intervention ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT01345968     History of Changes
Other Study ID Numbers: UKM10_0027, 2010-024115-14, 05-AnIt-09
Study First Received: April 21, 2011
Last Updated: August 7, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Anemia
Hemorrhage
Hematologic Diseases
Pathologic Processes
Ferric Compounds
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014