Impact of Preoperative Treatment of Anemia and Iron Deficiency in Cardiac Surgery on Outcome.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,003
- 试验地点
- 1
- 主要终点
- Red blood cell (RBC) units transfused
研究概览
简要总结
We are performing the above prospective randomized trial in 1'000 patients undergoing cardiac surgery. The study will answer the question of whether preoperative treatment of anemia or iron deficiency indeed improves transfusion needs (primary outcome) and important clinical outcomes (secondary outcome) in a large group of cardiac surgical patients. The list of inclusion and exclusion criteria was deliberately chosen short so that this patient group largely reflects today's clinical practice .
- Trial with medical product
详细描述
Anemic or iron deficiency patients are randomized into treatment and placebo groups. Treatment (see below) will be given the day before the operation (day -1) or a maximum of 2 days prior to the operation (day -2) in iron deficiency patients and a maximum of 3 days prior to the operation in anemic patients (day -3). The treatment will not be disclosed to the patient or the health care workers treating the patients during and after the operation.
Patients without anemia or iron deficiency will also be observed and the same postoperative measurements performed. They will serve as a natural comparison group.
Treatment:
Erythropoietin alpha (Eprex, Janssen-Cilag AG, Baar) 40'000 U sc. Ferric carboxymaltose (Ferinject, Vifor (International) AG, St. Gallen) 1000 mg in 100 ml sodiumchloride (NaCl) over 30 min.
Vitamin B12 (Vitarubin®-superconc., Streuli Pharma AG, Uznach) 1 mg sc. Folic acid (Acidum folicum, Streuli Pharma AG, Uznach) 5 mg po.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
研究组 & 干预措施
Anemia
Hb < 120 g/L in women, Hb < 130 g/L in men Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid
干预措施: Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid (Drug)
Iron deficiency
ferritin < 100 µg/l Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid
干预措施: Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid (Drug)
结局指标
主要结局
Red blood cell (RBC) units transfused
时间窗: 7 days
次要结局
- New atrial fibrillation(90 days)
- Infections(7 days)
- Length of stay (LOS) in the hospital(90 days)
- Acute kidney failure(7 days)
- Comparison of the treatment and placebo groups with the natural comparison group(90 days)
- Percentage of patients without any RBC transfusions(90 days)
- Combined allogeneic transfusions (RBC, FFP( fresh frozen plasma), platelets)(90 days)
- Length of stay in the intensive care unit (ICU)(90 days)
- Duration of mechanical ventilation(90 days)
- Thrombotic and thromboembolic complications (90 days)(90 days)
- Safety and tolerance of administered study drug and placebo(90 days)
- Costs (for blood products and pharmaceutical products related to transfusion and anemia management)(90 days)
- Major Adverse Cardiac and Cerebrovascular Events (MACCE)(90 days)
- 30 day and 90-day mortality(90 days)
- Calculated RBC and blood loss(90 days)
- Length of hospital stay (in comparison to median LOS published for relevant Swiss-DRGs)(90 days)
- In hospital mortality(90 days)
- Perioperative Hb concentrations(90 days)