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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Seoul, 대한민국, 03080
- Seoul National University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
다른 이름들:
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간섭 없음: Control
Patients in this group would receive 100ml of normal saline after main procedure of total knee arthroplasty.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative anemia
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Transfusion
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- H-1709-079-885
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