Effect of Preoperative Iron Isomaltoside 1000 Administration on Hemoglobin Concentration in Patients Undergoing Transcatheter Aortic Valve Implantation: a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Hemoglobin (Hb) concentration
研究概览
简要总结
Transcatheter aortic valve implantation (TAVI) is a standard procedure for severe aortic stenosis patients with moderate or higher risk of surgery. Several studies have reported the adverse effects of blood disorders, such as anemia and iron deficiency, on the prognosis of patients undergoing TAVI, and many other studies have been conducted to find ways to prevent them.
Iron isomaltoside, the latest intravenous iron supplement, can effectively replenish iron store with a single high-dose injection. Research has shown that a preoperative single high-dose iron isomaltoside (1000mg) safely increased hemoglobin levels after surgery in patients undergoing cardiac surgery. However, there have been no studies on the effect of ultra-short-term use of intravenous iron supplements prior to TAVI procedure.
Therefore, we investigate the effect of a single high-dose of iron isomaltoside (20mg/kg, maximum dose: 1g) on the hemoglobin concentration after the TAVI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Neither participants, all care providers, investigators nor outcomes assessors know the treatment allocations.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 60 years and undergoing transcatheter aortic valve implantation (TAVI)
排除标准
- •Emergency operation
- •Cardiogenic shock or ventricular-assist device (eg. ECMO, IABP)
- •Infectious condition
- •Active bleeding
- •Hypokalemia
- •Severe chronic kidney disease (GFR(CKD-EPI) <30mL/min/1.73m2) or Dialysis
- •Patients taking erythropoietin
- •Aplastic anemia, Hemolytic anemia
- •Hemochromatosis, Hemosiderosis
- •Uncompensated liver cirrhosis, Acute hepatitis, Alcoholism
- •Peptic / Duodenal ulcer, Crohn's disease, Ulcerative colitis
- •Allergy to iron supplements or vitamin B12
- •Symptomatic asthma, eczema
- •Immunologic disease (e.g. Rheumatoid arthritis, Systemic lupus erythematosus)
- •Malignancy
- •Patients being treated in the intensive care unit due to heart failure or other major complications
- •Patients who participated in other clinical studies that could affect prognosis
- •Patients who cannot understand the informed consent (eg. Foreigner)
研究组 & 干预措施
Control group
Participants in this group are administered N/S.
干预措施: Normal saline (Drug)
Iron isomaltoside group
Participants in this group are administered Iron isomaltoside & Vitamin B12.
干预措施: Iron isomaltoside (Drug)
结局指标
主要结局
Hemoglobin (Hb) concentration
时间窗: 2 weeks after TAVI (when the participant has not been discharged for 2 weeks) or 1st outpatient visit after TAVI (when the participant has been discharged within 2 weeks)
Compare the Hb concentrations between the Iron isomaltoside group and the Control group.
次要结局
- Transfusion requirement(During 2 weeks after TAVI (when the participant has not been discharged for 2 weeks) or until 1st outpatient visit after TAVI (when the participant has been discharged within 2 weeks))
- Functional performance - Essential frailty toolset (EFT)(2 weeks after TAVI (when the participant has not been discharged for 2 weeks) or 1st outpatient visit after TAVI (when the participant has been discharged within 2 weeks))
- Functional performance - Handgrip(2 weeks after TAVI (when the participant has not been discharged for 2 weeks) or 1st outpatient visit after TAVI (when the participant has been discharged within 2 weeks))
- Cognitive function - MMSE-K (Mini Mental State Exam)(2 weeks after TAVI (when the participant has not been discharged for 2 weeks) or 1st outpatient visit after TAVI (when the participant has been discharged within 2 weeks))
- Depression - SGDS-K (Short geriatric Depression Scale)(2 weeks after TAVI (when the participant has not been discharged for 2 weeks) or 1st outpatient visit after TAVI (when the participant has been discharged within 2 weeks))