Anemia, Orthopedic Surgery, High Risk of Blood Loss
Conditions
Keywords
anemia, transfusion, intravenous ferric carboxymaltose
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
Interventions
iv administration of max. 50 ml (Dilution: 20 ml in 30 ml NaCl 0.9%) in 30 minutes
DRUGNaCl 0.9%
iv administration of max. 50 ml in 30 minutes
Sponsors
Vifor Pharma
University Hospital Muenster
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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) * anemia * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of RBC units | Until postoperative day 7 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood transfusion rate | Until postoperative day 7 | Number of patients with blood transfusions |
| Frequency of postoperative complications | Until postoperative day 7 | Number of postoperative complications from baseline until postoperative day 7 |
| Length of hospital stay | 6 weeks after surgical intervention | — |
Countries
Germany
Outcome results
None listed