Efficacy and Safety of Intravenous Iron Sucrose in Patients With Hip Fracture to Prevent Perioperative Anemia
试验速览
- 阶段
- 4 期
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Transfusional needs
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of intravenous iron sucrose in patients with hip fracture and surgical intervention to prevent perioperative anemia.
详细描述
The main objective of this study is to evaluate the safety and efficacy of intravenous iron sucrose in patients with hip fracture and surgical intervention to prevent perioperative anemia.
It will also determine whether intravenous iron sucrose administration improve outcomes as Haemoglobin values, transfusional needs, postoperative complications, length of hospital stay and cost-effectiveness.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 65 years old
- •With Hip fracture or peritrochanteric fracture.
- •Who needs surgical intervention.
- •And sign the informed consent form.
排除标准
- •Tumor pathological fracture.
- •Two or more long bone fractures.
- •Seric Ferritin levels > 300 ng/ml.
- •Hypersensitivity to Iron sucrose or any component of the formulation.
- •Patients with allogeneic transfusion rejection.
- •Patients with previous blood transfusion request (Hb< 8g/dl).
- •Patients treated with hematopoietic growth factors.
- •Patients with Anticoagulant treatment, due to thromboembolic high risk disease.
- •Asthma in treatment.
- •Cirrhosis, Acute Hepatitis, or increased Aminotransferases (> 3 times the upper limit of normal).
- •Advanced Dementia (GDS>5) from the Global Deterioration Scale.
结局指标
主要结局
Transfusional needs
时间窗: 1st, 5th day and 1st and 6 th month after surgical intervention.
Blood transfusion rate in patients over 65 years undergone hip fracture and surgical intervention.
次要结局
- Units of packed cells(1st and 5th days, 1st and 6th month after surgical intervention.)
- Postoperative complications(1st and 5th day , 1st and 6th month after surgical intervention.)