Seoul National University Hospital
Seoul, 03080, South Korea
NCT Number: NCT03470649
Postoperative anemia is a frequent complication after total knee arthroplasty, with an incidence of 87%. Iron supplementation is known to be effective in treatment and prevention of postoperative anemia. The investigators examined the effect of intravenous iron isomaltoside (Monofer®) administration on postoperative anemia and transfusion requirements in patients undergoing total knee arthroplasty.
Participants undergoing total knee arthroplasty will be randomly assigned to treatment group or control group. After main procedure of total knee arthroplasty, iron isomaltoside 1000 (Monofer®) or normal saline will be intravenously administered depending on the group assigned. The dose of iron isomaltoside will be determined based on patient's body weight using the manufacturer's recommendation. Serum hemoglobin, hematocrit, iron, ferritin, transferrin saturation, and phosphorus level will be checked at preoperative day, postoperative day 1, 7, and 30.
The primary outcome is the incidence of postoperative anemia at 30 days after surgery. Secondary outcomes included the incidence and amount of red blood cell transfusion during admission period, hospital length of stay, the incidence of surgical site infection, and quality of life during postoperative period.
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Notify Me19 year and older
All sexes
Interventional
Not applicable
Seoul, 03080, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Iron Isomaltoside 1000 would be intravenously administrated to treatment group after main procedure of total knee arthroplasty.
Other names: treatment
Time frame: 30 days after surgery
Incidence of postoperative anemia at 30 days after surgery
Time frame: During admission period for surgery, an average of 2 weeks
Incidence and amount of red blood cell transfusion during admission
Time frame: 1 day, 7 days, and 30 days after surgery
serum hemoglobin level (g/dL)
Time frame: 1 day, 7 days, and 30 days after surgery
Hematocrit level (%)
Time frame: 1 day, 7 days, and 30 days after surgery
serum iron level (μg/dL)
Time frame: 1 day, 7 days, and 30 days after surgery
serum ferritin level (ng/mL)
Time frame: 1 day, 7 days, and 30 days after surgery
Transferrin saturation (%)
Time frame: 1 day, 7 days, and 30 days after surgery
Serum phosphorus level (mg/dL)
Time frame: During admission period for surgery, an average of 2 weeks
Incidence of surgical site infection
Time frame: During admission period for surgery, an average of 2 weeks
Hospital length of stay (days)
Time frame: 30 days after surgery
Assessment of quality of life during postoperative periods using EQ-5D (EuroQol-5 Dimension) questionaire
Time frame: 30 days after surgery
Assessment of quality of life during postoperative periods using FACT-An (The Functional Assessment of Cancer Therapy-Anemia) questionaire
Seoul National University Hospital
Other
Effect of Intravenous Iron Isomaltoside on Postoperative Anemia in Patients Underwent Total Knee Arthroplasty: A Single-blind Randomized Controlled Trial
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