Effect of Intravenous Ferric Carboxymaltose on Hemoglobin Response and Transfusion in Patients With Iron Deficiency Anemia After Off-Pump Coronary Artery Bypass Grafting
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total mediastinal blood loss and transfusion counts
研究概览
简要总结
In this prospective open-label randomized tral, 100 patients with elective off-pump coronary artery bypass (OPCAB) or minimal invasive direct coronary bypass (MIDCAB) surgery were enrolled. Before surgery, if a patient had iron deficiency anemia, the patient was randomized to receive Ferinject®(Ferric carboxymaltose, n=50) or placebo (normal saline, n=50), respectively. A single dose should not exceed 1000mg of iron per day or 20mg per kg body weight. In addition, the administration of 1000mg of iron should not exceed once a week. Administration to patients with hemodialysis-dependent chronic kidney disease is once daily, and the maximum dose should not exceed 200 mg (4 ml) of iron. Patients weighing less than 35 kg should not exceed 500 mg total iron dose. It uses intravenous infusion and can be administered up to 1,000mg (20ml) as the maximum iron once. For intravenous infusion, this drug is diluted with 0.9% sterile physiological saline solution.
详细描述
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Perioperative blood loss and iatrogenic hemodilution lead to postoperative anemia which correlates with infections, and poor physical function, mobility and recovery with subsequent increases in the length of hospital stay and mortality. Preoperative anemia management reduce intraoperative blood loss such as normothermia, antifibrinolytics and cell salvage are key strategies to ameliorate postoperative anemia.
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Patient screening method Off-pump coronary artery bypass (OPCAB) under median-sternotomy, or minimal invasive direct coronary bypass (MIDCAB) undertaken under median-sternotomy Among them, the selection/exclusion criteria are checked and the subjects of the study are screened. * Inclusion/ exclusion criteria **Inclusion:
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Patients with Preoperative iron deficiency anemia Among Patients scheduled for cardiopulmonary coronary artery bypass graft under median sternotomy in cardiovascular surgery **Exclusion: - a) Patients who underwent iron correction treatment (oral, injection, blood transfusion) within 2 months prior to surgery b) Patients taking anticoagulants before surgery c) Patients taking and administering drugs that can cause bone marrow suppression, such as anticancer drugs, before surgery d) Patients with chronic liver disease and chronic kidney disease undergoing dialysis e) Patients scheduled for coronary artery bypass graft for emergency surgery f) Patients with a history of hypersensitivity reactions and side effects to iron drugs g) Minor (under 20 years old) 3) Definition of iron deficiency anemia (if all criteria a to c in the following items are satisfied)
- Ferritin<300mcg/L
- Transferrin saturation<25%
- Hb<12.0g/dL for women or Hb<13.0g/dL for men * The primary goal of this study was the effect of intravenous administration of ferric carboxymaltose on postoperative hemoglobin levels in patients with preoperative iron deficiency anemia among patients requiring cardiopulmonary coronary artery bypass grafting due to coronary artery disease. It is to analyze the effect compared to the control.
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
- Single (Participant)
盲法说明
Patients were offered the allocated treatment for ferric carboxymaltose or not, using the block randomization system. The selected agent was infused to patients after randomization.
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 19 years or older
- •undergoing elective OPCAB or MIDCAB surgery with multi-vessel coronary artery disease.
排除标准
- •Patients who underwent iron correction treatment (oral, injection, blood transfusion) within 2 months prior to surgery
- •Patients taking anticoagulants before surgery
- •Patients taking and administering drugs that can cause bone marrow suppression, such as anticancer drugs, before surgery
- •Patients with chronic liver disease and chronic kidney disease undergoing dialysis
- •Patients scheduled for coronary artery bypass graft for emergency surgery
- •Patients with a history of hypersensitivity reactions and side effects to iron drugs
- •Minor (under 20 years old)
- •Definition of iron deficiency anemia (if all criteria a to c in the following items are satisfied)
- •Ferritin<300mcg/L
- •Transferrin saturation<25%
- •Hb<12.0g/dL for women or Hb<13.0g/dL for men
研究组 & 干预措施
Ferinject®
干预措施: Ferinject (Drug)
Normal saline
干预措施: Normal Saline Flush (Drug)
结局指标
主要结局
Total mediastinal blood loss and transfusion counts
时间窗: At admission periods for Off-Pump Coronary Artery Bypass or Minimally Invasive Direct Coronary Artery Bypass surgery (Mean 8~9 days)
For cost-effectiveness analysis of ferric carboxymaltose in preoperative iron treatment
次要结局
- total length of intensive care unit (ICU) stay(mean 3-4 days)
- rate of surgical revision for bleeding(intraoperative)
- rate of postoperative morbidity(Participants will be followed during 1 years from operation)
- amount of blood products transfused both intraoperatively and postoperatively(24 hours later after surgery)
- rate of postoperative mortality(Participants will be followed during 1 years from operation)
- blood loss in the operative day(24 hours later after surgery)