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Intravenous Ferric Carboxymaltose (Ferinject®) With or Without Erythropoietin in Patients Undergoing Orthopaedic Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by University of Zurich.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Vifor Inc.
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00706667
First received: June 25, 2008
Last updated: June 2, 2009
Last verified: June 2009
History of Changes
  Purpose

Study Design: Single-centre, block randomised, blinded, controlled, phase IIIb, parallel group pilot study.

Primary Objective:

• To evaluate the effect of the administration of ferric carboxymaltose (Ferinject®) with or without erythropoietin vs. no treatment (standard therapy) on the preoperative anaemia status in patients undergoing orthopaedic surgery

Secondary Objective:

  • To gain informations for the design of a possible follow-up study
  • To evaluate the effect of the administration of ferric carboxymaltose (Ferinject®) with or without erythropoietin vs. no treatment (standard therapy) on pre- and postoperative Hb levels, iron status, transfusion rate, days until discharge.
  • To evaluate the tolerability and safety of Ferinject®

Study Centres:

This is a single centre study

Patients:

A total of 75 completed patients (50 patients in the intravenous iron treatment groups and 25 patients in the no treatment group will be recruited.


Condition Intervention Phase
Iron Deficiency Anemia
 Drug: Ferinject ®
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Intravenous Ferric Carboxymaltose (Ferinject®) With or Without Erythropoietin for the Correction of Preoperative Anaemia in Patients Undergoing Orthopaedic Surgery

Resource links provided by NLM:

MedlinePlus related topics: Anemia Iron
U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Hb increase from baseline till day of surgery [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: May 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo for EPO and for Ferinject ®
 Drug: Ferinject ®
iv administration in Arm 1 placebo NaCl 0.9% In arm 2 iv administration of Ferinject ® and subcutaneous NaCl 0.9 % as an EPO placebo In arm 3 iv administration of Ferinject ® and subcutaneous EPO
Active Comparator: 2
Only Ferinject ® , Placebo for EPO
 Drug: Ferinject ®
iv administration in Arm 1 placebo NaCl 0.9% In arm 2 iv administration of Ferinject ® and subcutaneous NaCl 0.9 % as an EPO placebo In arm 3 iv administration of Ferinject ® and subcutaneous EPO
Active Comparator: 3
Ferinject ® + EPO
 Drug: Ferinject ®
iv administration in Arm 1 placebo NaCl 0.9% In arm 2 iv administration of Ferinject ® and subcutaneous NaCl 0.9 % as an EPO placebo In arm 3 iv administration of Ferinject ® and subcutaneous EPO

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 18 years of age and signed written informed consent
  • Patients scheduled to undergo major orthopaedic surgery (hip or knee arthroplasty or back surgery)
  • 10 g/dl < Hb < 13.0 g/dl for men and 10 g/dl < Hb < 12.0 g/dl for women, at screening ( 3 weeks prior to surgery)
  • Ferritin < 100 μg/l or 100-300 with TSat < 20%

Exclusion Criteria:

  • Suspicion of iron overload (Ferritin >300 μg/l or/and TSAT>50%)
  • Active severe infection/inflammation (defined as serum CRP > 20 mg/l) or diagnosed malignancy
  • Folate-and/or Vitamin B12 deficiency (according to local lab reference range)
  • Known history of hepatitis B/C or HIV-positive
  • Liver values 3 times higher than normal
  • Immunosuppressive or myelosuppressive therapy
  • A concurrent medical condition(s) that, in the view of the investigator, would prevent compliance or participation or jeopardize the health of the patients.
  • Pregnancy or lactation
  • Transfusion within 1 month prior to study inclusion, EPO treatment with in the last 4 weeks, any iron treatment within 4 weeks prior to the inclusion in the trail
  • Participation in any other therapeutic trial within the previous month
  • History of thromboembolic events in the family or the patient
  • Severe peripheral, coronary or carotid artery disease
  • Bodyweight < 50 kg
  • Patients not able to understand the German language
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00706667

Contacts
Contact: 01 Studienregister MasterAdmins +41 (0)44 255 11 11

Locations
Switzerland
Universitätsspital Zürich Recruiting
Zurich, Switzerland, 8091
Contact: Oliver M Theusinger, MD     +41442552695     oliver.theusinger@usz.ch    
Sponsors and Collaborators
University of Zurich
Vifor Inc.
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

Responsible Party: Dr.med. Oliver M. Theusinger, Institute for Anesthesiology
ClinicalTrials.gov Identifier: NCT00706667     History of Changes
Other Study ID Numbers: StV 07-2008
Study First Received: June 25, 2008
Last Updated: June 2, 2009
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Anemia
Deficiency Diseases
Anemia, Iron-Deficiency
Hematologic Diseases
Malnutrition
Nutrition Disorders
Anemia, Hypochromic
Iron Metabolism Disorders
 Metabolic Diseases
Epoetin Alfa
Ferric Compounds
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013