Anemia, Knee Arthropathy
Conditions
Brief summary
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.
Interventions
Iron Isomaltoside 1000 would be intravenously administrated to treatment group after main procedure of total knee arthroplasty.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients undergoing total knee arthroplasty
Exclusion criteria
* bilateral total knee arthroplasty * hematochromatosis or hemosiderosis * hemolytic anemia * history of drug allergy * liver cirrhosis or hepatitis * systematic lupus erythematosus * rheumatic arthritis * allergic disease * history of transfusion within one month from surgery * parturient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative anemia | 30 days after surgery | Incidence of postoperative anemia at 30 days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin | 1 day, 7 days, and 30 days after surgery | serum hemoglobin level (g/dL) |
| Hematocrit | 1 day, 7 days, and 30 days after surgery | Hematocrit level (%) |
| Iron | 1 day, 7 days, and 30 days after surgery | serum iron level (μg/dL) |
| Ferritin | 1 day, 7 days, and 30 days after surgery | serum ferritin level (ng/mL) |
| Transferrin saturation | 1 day, 7 days, and 30 days after surgery | Transferrin saturation (%) |
| Transfusion | During admission period for surgery, an average of 2 weeks | Incidence and amount of red blood cell transfusion during admission |
| Surgical site infection | During admission period for surgery, an average of 2 weeks | Incidence of surgical site infection |
| Hospital length of stay | During admission period for surgery, an average of 2 weeks | Hospital length of stay (days) |
| Quality of life using EQ-5D | 30 days after surgery | Assessment of quality of life during postoperative periods using EQ-5D (EuroQol-5 Dimension) questionaire |
| Quality of life using FACT-An | 30 days after surgery | Assessment of quality of life during postoperative periods using FACT-An (The Functional Assessment of Cancer Therapy-Anemia) questionaire |
| Phosphorus | 1 day, 7 days, and 30 days after surgery | Serum phosphorus level (mg/dL) |
Countries
South Korea
Outcome results
None listed