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:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 3
- Locations
- 2
- Primary Endpoint
- Number of RBC units
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
Study Sites (2)
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