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Clinical Trials/NCT01345968
NCT01345968TerminatedPhase 4

Preoperative Intravenous Ferric Carboxymaltose (Ferinject) in Patients With Orthopedic Surgery and High Risk of Blood Loss

University Hospital Muenster2 sites in 1 country3 target enrollmentStarted: June 2011Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Terminated
Sponsor
Enrollment
3
Locations
2
Primary Endpoint
Number of RBC units
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)
  • •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

Arms & Interventions

NaCl 0.9%

Placebo Comparator

Intervention: NaCl 0.9% (Drug)

Ferinject

Experimental

Intervention: Ferinject 50 mg/ml (Drug)

Outcomes

Primary Outcomes

Number of RBC units

Time Frame: Until postoperative day 7

Secondary Outcomes

  • Frequency of postoperative complications(Until 6 weeks after surgical intervention)
  • Length of hospital stay(6 weeks after surgical intervention)
  • Blood transfusion rate(Until postoperative day 7)

Investigators

Sponsor
University Hospital Muenster
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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