Effect of IV Iron Isomaltoside on Postoperative Anemia in Total Knee Arthroplasty Patients
Effect of Intravenous Iron Isomaltoside on Postoperative Anemia in Patients Underwent Total Knee Arthroplasty: A Single-blind Randomized Controlled Trial
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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Seoul、大韓民国、03080
- Seoul National University Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Treatment
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.
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Iron Isomaltoside 1000 would be intravenously administrated to treatment group after main procedure of total knee arthroplasty.
他の名前：
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介入なし：Control
Patients in this group would receive 100ml of normal saline after main procedure of total knee arthroplasty.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Postoperative anemia
時間枠：30 days after surgery
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Incidence of postoperative anemia at 30 days after surgery
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30 days after surgery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Transfusion
時間枠：During admission period for surgery, an average of 2 weeks
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Incidence and amount of red blood cell transfusion during admission
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During admission period for surgery, an average of 2 weeks
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Hemoglobin
時間枠：1 day, 7 days, and 30 days after surgery
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serum hemoglobin level (g/dL)
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1 day, 7 days, and 30 days after surgery
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Hematocrit
時間枠：1 day, 7 days, and 30 days after surgery
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Hematocrit level (%)
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1 day, 7 days, and 30 days after surgery
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Iron
時間枠：1 day, 7 days, and 30 days after surgery
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serum iron level (μg/dL)
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1 day, 7 days, and 30 days after surgery
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Ferritin
時間枠：1 day, 7 days, and 30 days after surgery
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serum ferritin level (ng/mL)
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1 day, 7 days, and 30 days after surgery
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Transferrin saturation
時間枠：1 day, 7 days, and 30 days after surgery
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Transferrin saturation (%)
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1 day, 7 days, and 30 days after surgery
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Phosphorus
時間枠：1 day, 7 days, and 30 days after surgery
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Serum phosphorus level (mg/dL)
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1 day, 7 days, and 30 days after surgery
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Surgical site infection
時間枠：During admission period for surgery, an average of 2 weeks
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Incidence of surgical site infection
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During admission period for surgery, an average of 2 weeks
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Hospital length of stay
時間枠：During admission period for surgery, an average of 2 weeks
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Hospital length of stay (days)
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During admission period for surgery, an average of 2 weeks
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Quality of life using EQ-5D
時間枠：30 days after surgery
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Assessment of quality of life during postoperative periods using EQ-5D (EuroQol-5 Dimension) questionaire
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30 days after surgery
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Quality of life using FACT-An
時間枠：30 days after surgery
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Assessment of quality of life during postoperative periods using FACT-An (The Functional Assessment of Cancer Therapy-Anemia) questionaire
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30 days after surgery
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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- H-1709-079-885
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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