Effect of IV Iron Isomaltoside on Postoperative Anemia in Total Knee Arthroplasty Patients
- Registration Number
- NCT03470649
- Lead Sponsor
- Seoul National University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Adult patients undergoing total knee arthroplasty
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Iron Isomaltoside 1000 Patients in this group would receive Iron Isomaltoside 1000 (Monofer®) after main procedure of total knee arthroplasty. The dose of iron isomaltoside would be determined based on the patient's body weight.
- Primary Outcome Measures
Name Time Method Postoperative anemia 30 days after surgery Incidence of postoperative anemia at 30 days after surgery
- Secondary Outcome Measures
Name Time Method 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)
Phosphorus 1 day, 7 days, and 30 days after surgery Serum phosphorus level (mg/dL)
Transfusion During admission period for surgery, an average of 2 weeks Incidence and amount of red blood cell transfusion during admission
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 (%)
Hemoglobin 1 day, 7 days, and 30 days after surgery serum hemoglobin level (g/dL)
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
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of