(Study comparing the rate of hypophosphatemia and side effect when using Preoperative Ferric Carboxymaltose (FCM) vs Iron isomaltoside in unilateral Total Knee Arthroplasty: Randomized controlled trial)
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0009011
- Lead Sponsor
- Bundang CHA General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 104
Patients undergoing unilateral total knee arthroplasty
Aged 60 years or older
Patients with confirmed anemia in preoperative blood tests (hemoglobin levels for male patients between 8g/dL and 13g/dL, and for female patients between 8g/dL and 12g/dL)
- First operation Preop Hb <8g/dL, thrombocytopenia
- C-reactive protein 1 or more (> 2xUNL)
- Systemic inflammatory diseases
- Use of iron supplements within 4 weeks
- Intravenous iron, or erythropoietin within 4 weeks
- Preoperative use of anticoagulant (warfarin, factor Xa inhibitor)
- Coagulopathy
- Chronic renal failure
- Patients with hypersensitivity to this drug or its components
- Patients with known significant hyperalgesia to other parenteral iron preparations
- Patients with excessive iron or iron use disorder
- Patients with liver dysfunction
- Patients with acute or chronic infections (In cases of chronic infection, assessment of benefits and risks should be performed in consideration of red blood cell generation inhibition)
- Patients with asthma, eczema, atopic allergies and with their past medical history
- allergic patients including drug allergy
- Pregnant woman
- Patients weighing less than 35 kg
- Patients with surgical side effect associated with bleeding (If all the procedures are completed and there is uncontrolled bleeding after decompressing the torniquet prior to skin suture, bleeding related complications will be considered to have occurred.)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of postoperative hypophosphatemia
- Secondary Outcome Measures
Name Time Method hemoglobin