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

NCT00706667 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2013-06-20

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Vifor Pharma

    collaborator INDUSTRY

  • University of Zurich

    lead OTHER

Principal Investigators

  • Oliver Theusinger, MD · University Hospital Zurich, Division of Anaesthesiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00706667 on ClinicalTrials.gov