NCT03574311Unknown4 期
A Phase IV Double-blind, Randomised, Parallel Group Comparison of the Efficacy and Safety of Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Elective or Urgent Cardiac Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Incidence of allogeneic blood transfusion and/or nosocomial infection
研究概览
简要总结
This study evaluates the efficacy and safety of single dose preoperative ferric carboxymaltose in the prevention of postoperative infections and blood transfusions in patients scheduled for cardiac surgery. Half of the patients will receive ferric carboxymaltose and half of the patients physiological saline solution as placebo.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double blinding, study drug administration by separate staff blinded from participant and investigators
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Age < 35 years
- •Patients requiring , emergency or salvage cardiac surgical operation
- •Participation in another clinical study or treatment with another investigational product 30 days prior to randomization
- •Moribund patient not expected to survive surgery 12 months after surgery
- •Active malignant disease with a short life expectancy, not eligible for surgery
- •Hemoglobin levels > 155 g/dL for women and >167 g/dl for men (upper reference limits for TYKSlab)
- •Ferritin levels >150 ug/l for women and >400 ug/l for men.
- •Renal dialysis therapy for chronic renal failure or severe preoperative renal impairment (eGFR<30ml/min).
- •Study treatment can't be infused during the required time window: minimum 48 hours and maximum 21 days before the operation.
- •Ongoing oral or parenteral iron medication at the time of randomization
- •Iron or haemoglobin metabolism or synthesis disorders
- •Primary or secondary hemochromatosis (in males and postmenopausal females, a serum ferritin value of over 300 ng/mL (670 pmol/L); and in premenopausal females, a serum ferritin value of over 150[17] or 200[18] ng/mL (330 or 440 pmol/L) indicates iron overload).
- •Porphyria cutanea tarda.
- •Liver failure (Child-Pugh class B or C).
- •Body weight less than 50kg.
- •Ongoing antibiotic treatment other than prophylactic urine tract infection antibiotics.
研究组 & 干预措施
Ferric carboxymaltose
Experimental
Preoperative 1000 mg intravenous single dose as 30 minute infusion
干预措施: Ferric carboxymaltose (Drug)
Placebo
Placebo Comparator
Preoperative 100 ml saline as 30 minute infusion
干预措施: Physiological saline (Other)
结局指标
主要结局
Incidence of allogeneic blood transfusion and/or nosocomial infection
时间窗: 0-90 days
Composite of transfused red blood cell units and/or nosocomial infection
次要结局
- Days on vasoactive drugs(0-90 days)
- Acute heart failure(90 days)
- Worsening heart failure(0-90 days)
- ICU/CCU days(0-90 days)
- Length of stay(0-90 days)
- Mortality(0-90 days)
- Health related quality of life(12 months)
- Perioperative myocardial infarction(3 days)
- New onset atrial fibrillation (AF) or flutter(0-90 days)
- Ventilator free days(0-90 days)
- AKI (acute kidney injury)(0-90 days)
研究者
研究点 (1)
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