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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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. |
|
| Control | No Intervention | Patients in this group would receive 100ml of normal saline after main procedure of total knee arthroplasty. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron Isomaltoside 1000 | Drug | Iron Isomaltoside 1000 would be intravenously administrated to treatment group after main procedure of total knee arthroplasty. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative anemia | Incidence of postoperative anemia at 30 days after surgery | 30 days after surgery |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin-Tae Kim, Pf. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33259451 | Derived | Yoo S, Bae J, Ro DH, Han HS, Lee MC, Park SK, Lim YJ, Bahk JH, Kim JT. Efficacy of intra-operative administration of iron isomaltoside for preventing postoperative anaemia after total knee arthroplasty: A randomised controlled trial. Eur J Anaesthesiol. 2021 Apr 1;38(4):358-365. doi: 10.1097/EJA.0000000000001389. |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C557707 | iron isomaltoside 1000 |
| D013812 | Therapeutics |
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Randomized controlled trial
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|
| 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 |