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

NCT00706667 | Terminated Phase 4

• 1 other identifier: StV 07-2008
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

• Hb increase from baseline till day of surgery

  6 weeks

Study Arms (3)

1

PLACEBO COMPARATOR

Placebo for EPO and for Ferinject ®

Drug: Ferinject ®

2

ACTIVE COMPARATOR

Only Ferinject ® , Placebo for EPO

Drug: Ferinject ®

3

ACTIVE COMPARATOR

Ferinject ® + EPO

Drug: Ferinject ®

Interventions

Ferinject ® DRUG

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

1; 2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years of age and signed written informed consent
• Patients scheduled to undergo major orthopaedic surgery (hip or knee arthroplasty or back surgery)
• 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%

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Zurich: lead
• Vifor Pharma: collaborator

Study Sites (1)

University Hospital Zurich, Division of Anaesthesiology

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Oliver Theusinger, MD

  University Hospital Zurich, Division of Anaesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2008
• First Posted: June 27, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 20, 2013

Record last verified: 2013-06

Locations

CH (1)