Intravenous Iron Supplement to Prevent Postoperative Delirium After Hip Fracture Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Postoperative delirium
研究概览
简要总结
This is a clinical trial to evaluate the effect of intravenous iron supplement with Ferinject (Ferric Carboxymaltose) in preventing postoperative delirium after hip fracture surgery.
详细描述
We hypothesized that IV iron supplement will (1) decrease postoperative delirium in hip fracture patients and (2) decrease the amount of transfusion and transfusion-related complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •femur neck fracture, intertrochanteric fractures
- •Iron deficiency anemia (Hb<12 in women, Hb<13 in men)
- •Iron deficiency (Serum ferritin <100ug/L or transferrin saturation<20%)
- •Who understands this clinical trial and volunteers and agrees to this trial
排除标准
- •Patient under the age of 65 years
- •Hb<7 or someone who has acute symptom of anemia(tachycardia, dyspnea, or dizziness)
- •High energy trauma
- •Preoperative delirium
- •Underlying disease which involves cognitive dysfunction (e.g. neurovascular diseases, acute myocardial infarction, pulmonary embolism)
- •Those who are inappropriate to participate in the clinical trial assessed by the investigators
研究组 & 干预措施
Ferinject group
This group of hip fracture patients are treated with intravenous Ferinject between the admission and the surgery day.
干预措施: Ferinject (Drug)
Control group
This group of hip fracture patients are treated with normal saline as a control group.
干预措施: Normal saline (Drug)
结局指标
主要结局
Postoperative delirium
时间窗: since immediately after the surgery to the discharge date
The presence and duration of postoperative delirium
次要结局
- Functional outcomes(since immediately after the surgery to the discharge date)
- Transfusion-related complications(since immediately after the surgery to the discharge date)
- Hematologic outcomes(since immediately after the surgery to the discharge date)
- Postoperative transfusion(Postoperative admission datessince immediately after the surgery to the discharge date)
研究者
Young-Kyun Lee
Professor
Seoul National University Bundang Hospital