Effect of IV Iron Isomaltoside on Postoperative Anemia in Total Knee Arthroplasty Patients

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Intravenous Iron Isomaltoside on Postoperative Anemia in Patients Underwent Total Knee Arthroplasty: A Single-blind Randomized Controlled Trial

Conditions
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Anemia, Knee Arthropathy

Intervention / Treatment
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* Drug: Iron Isomaltoside 1000


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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. | Drug: Iron Isomaltoside 1000<br>* Iron Isomaltoside 1000 would be intravenously administrated to treatment group after main procedure of total knee arthroplasty.<br>* Other names: treatment;|
| No Intervention: Control<br>Patients in this group would receive 100ml of normal saline after main procedure of total knee arthroplasty. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative anemia | Incidence of postoperative anemia at 30 days after surgery | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusion | Incidence and amount of red blood cell transfusion during admission | During admission period for surgery, an average of 2 weeks | 
| Hemoglobin | serum hemoglobin level (g/dL) | 1 day, 7 days, and 30 days after surgery | 
| Hematocrit | Hematocrit level (%) | 1 day, 7 days, and 30 days after surgery | 
| Iron | serum iron level (μg/dL) | 1 day, 7 days, and 30 days after surgery | 
| Ferritin | serum ferritin level (ng/mL) | 1 day, 7 days, and 30 days after surgery | 
| Transferrin saturation | Transferrin saturation (%) | 1 day, 7 days, and 30 days after surgery | 
| Phosphorus | Serum phosphorus level (mg/dL) | 1 day, 7 days, and 30 days after surgery | 
| Surgical site infection | Incidence of surgical site infection | During admission period for surgery, an average of 2 weeks | 
| Hospital length of stay | Hospital length of stay (days) | During admission period for surgery, an average of 2 weeks | 
| Quality of life using EQ-5D | Assessment of quality of life during postoperative periods using EQ-5D (EuroQol-5 Dimension) questionaire | 30 days after surgery | 
| Quality of life using FACT-An | Assessment of quality of life during postoperative periods using FACT-An (The Functional Assessment of Cancer Therapy-Anemia) questionaire | 30 days after surgery |