Efficacy and Safety of Perioperative Iron Supplementation for Postoperative Rehabilitation of Geriatric Hip Fractures: a Multicenter, Randomized, Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 444
- 试验地点
- 1
- 主要终点
- 6-minute walk distance
研究概览
简要总结
Geriatric hip fracture is an important disease that affects the health life of the elderly in China. Geriatric hip fracture is often complicated by a variety of comorbidities due to advanced age. And anemia is a common comorbidity. At present perioperative management of geriatric hip fracture, transfusion is only indicated for moderate and severe anemia, while no special medical intervention for mild anemia in China. More and more studies have found that iron can not only correct anemia, but also improve cardiac function, patients' quality of life and function. This study investigated the effect of perioperative iron supplementation on activity tolerance in elderly patients with hip fracture complicated with iron deficiency anemia. The study was a randomized, parallel controlled clinical study. Due to the requirements of the ethics committee, the unblinded setting was cancelled due to ethical considerations. Research will be grouped according to whether to accept iron supplementation treatment, are divided into 2 groups, respectively, iron treatment group and the traditional method. The method of randomization was stratified block randomization. The experimental group added to the intravenous iron sucrose during perioperative period according to the degree of iron deficiency. If there is still a iron deficiency or anemia at discharge, oral ferrous lactate is added after discharge. The outcomes include 6-minute walk distance, Harris score, EQ-5D score six months after surgery, perioperative blood transfusion rate, and so on in the two groups.
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 (Investigator, Outcomes Assessor)
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
- •>65 years old patients with hip fracture
- •Patients with iron deficiency or anemia,
- •preoperative hemoglobin <13g/ dL in males and <12g/ dL in females, and >9g/ dL,
- •serum ferritin < 100 ng/ mL or serum ferritin 100-299 ng/ mL or transferrin saturation (TSAT) <20%
排除标准
- •Coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, and cardiac device implantation (including cardiac resynchronization) within preoperative 30 days
- •Acute coronary syndrome, transient ischemic attack or stroke occurred within 30 days before surgery;
- •Refused to sign the consent form to be included in the clinical trial group;
- •Can't walk before injury;
- •Use erythropoietic preparation within 3 months before surgery and oral iron preparation within 4 weeks 30 days before surgery(> 100 mg/ day)
- •Patients with liver and kidney dysfunction
- •Other conditions that the researchers considered inappropriate for inclusion
研究组 & 干预措施
iron supplement group
干预措施: iron sucrose and ferrous lactate (Drug)
结局指标
主要结局
6-minute walk distance
时间窗: 6 months
The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise. The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions.
次要结局
- Harris hip score(6 months)
- perioperative blood transfusion rate(1 week)
研究者
He Qifei
Principal Investigator
Shenzhen Second People's Hospital