Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients: a Randomized Controlled Trial'
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 310
- 试验地点
- 2
- 主要终点
- Disability
研究概览
简要总结
Postoperative anemia is common in cardiac surgery with cardiopulmonary bypass. Iron deficiency delays the recovery from postoperative anemia and may negatively affect the postoperative trajectory of cardiac surgery patients. The objective of the study is to determine the effect of treatment of postoperative iron deficiency anemia with intravenous iron on disability 90 days after surgery. This will be evaluated in a randomized placebo-controlled double blind two-center trial in which 310 elective cardiac surgery patients will be included.
详细描述
Rationale: Postoperative anemia is common in cardiac surgery with cardiopulmonary bypass. Iron deficiency delays the recovery from postoperative anemia and may negatively affect the postoperative trajectory of cardiac surgery patients.
Objective: To determine the effect of treatment of postoperative iron deficiency anemia (IDA) with intravenous iron (IVI) on disability 90 days after surgery.
Study design: Randomized placebo-controlled double blind two-center trial
Study population: 310 elderly patients (≥70 years) with moderate postoperative IDA on postoperative day (POD) 1 (hemoglobin (Hb) 85 - 110 g/L, ferritin concentration < 100 µg/L or iron saturation <20%) after uncomplicated elective cardiac surgery (aortic valve repair (AVR) and coronary artery bypass graft (CABG) surgery).
Intervention: Postoperative treatment with a single dose IVI (ferric derisomaltose, Monofer®, N = 155) compared to postoperative treatment with sodium chloride (NaCL) 0.9% (placebo, N = 155).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Investigator and patient will be blinded for treatment allocation. As the IVI solution is brown and the placebo solution is colourless, the infusion bags and lines will be light-protected in order to prevent identification of the investigational product.
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mentally competent with age ≥ 70 years
- •Elective AVR or CABG surgery
- •Expected uncomplicated postoperative trajectory, defined as:
- •No inotropic agents or ventilation at time of final inclusion (POD 1)
- •Expected discharge to general ward at POD 1
- •Moderate postoperative IDA, defined as:
- •Hb between 85 and 110 g/L and
- •Ferritin <100 µg/L or
- •Iron saturation (TSAT) < 20%
排除标准
- •Medical history of iron overload/haemochromatosis
- •Medical history of liver cirrhosis or ALT/AST value in blood serum triple of normal value (female patients: ALT >120, AST >105 U/L. Male patients: ALT>150, AST>135 U/L)
- •Severe renal failure (eGFR<15ml/min/1.73m2)
- •Recent treatment with IVI (<12 weeks prior)
- •Serious or severe allergic reaction to IVI in medical history
- •Severe asthma or eczema in medical history (atopic constitution)
研究组 & 干预措施
Intravenous iron (ferric derisomaltose)
The intervention consists of a single dose of ferric derisomaltose (Monofer®) 100 mg/mL solution for infusion (Monofer® is a registered product with a marketing authorization in the Netherlands (RVG number: 103070). Manufacturer: Pharmacosmos A/S, Denmark. Dutch marketing authorization holder: Cablon Medical B.V). The method of administration and dosage of the investigational medication are standard treatment. The ferric derisomaltose dose will calculated for each patient depending on body weight (20mg/kg) and diluted in 250 ml NaCl 0.9%. Treatment takes approximately 60 minutes. Vital signs of the patient will be monitored during administration of the investigational medication and for 30 minutes afterwards
干预措施: Ferric Derisomaltose 100 MG/ML (Drug)
Placebo
Single dose of sodium chloride 0.9% (250ml). Treatment takes approximately 60 minutes. Vital signs of the patient will be monitored during administration of the investigational medication and for 30 minutes afterwards
干预措施: Sodium chloride (Drug)
结局指标
主要结局
Disability
时间窗: 90 days after elective cardiac surgery
Disability measured by the 12- item World Health Organization Disability Assessment score 2.0 (WHODAS-12). Based on the answers a disability score can be calculated. 0% is no disability and 100% is fully disabled.
次要结局
- Change in reticulocyte hemoglobin content(+/- 7 days after elective cardiac surgery)
- Change in patient reported outcome measures (PROMs) related to dyspnea(90 days after elective cardiac surgery)
- Change in patient reported outcome measures (PROMs) related to health related quality of life (HRQL)(90 days after elective cardiac surgery)
- Red blood cell transfusions(+/- 7 days after elective cardiac surgery)
- Change in Hb level(+/- 7 days after elective cardiac surgery)
- Postoperative complications(+/- 7 days after elective cardiac surgery)
- Days alive and out of hospital(90 days after elective cardiac surgery)
研究者
dr. P. Noordzij
Principal investigator
St. Antonius Hospital