Efficacy and Safety of Erythropoietin And/Or Intravenous Iron Sucrose For Treatment of Anemia In Hip and Knee Arthroplasty: A Single-center Retrospective Study
试验速览
- 阶段
- 不适用
- 入组人数
- 780
- 试验地点
- 1
- 主要终点
- Differences in changes of Hb level in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.
研究概览
简要总结
Perioperative anemia is very common in patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA). This study retrospectively analyzes the use of rHuEPO and iron sucrose in patients undergoing total hip and knee arthroplasty in order to observe the short-term efficacy and safety of rHuEPO and iron sucrose.
详细描述
This study aims to explore whether short-term use of rHuEPO and iron sucrose can improve postoperative anemia and promote postoperative rehabilitation after hip and knee arthroplasty. According to different therapies of perioperative anemia , included subjects would be divided into rHuEPO monotherapy group, iron sucrose monotherapy group, rHuEPO combined with iron sucrose group and control group (without rHuEPO and iron sucrose).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent hip or knee arthroplasty between May 1, 2012 (included) and December 31, 2015 in Peking Union Medical College Hospital
- •Age ≥ 18 years, sex unlimited
排除标准
- •Patients with serious absence of clinical data
- •Patients with rHuEPO contraindication
- •Patients with uncontrolled severe hypertension
- •Patients allergic to this product and other mammalian cell derivatives, or to human serum albumin
- •Co-infected patients
- •Patients definitely allergic to iron sucrose injection
- •Patients with coagulation dysfunction
研究组 & 干预措施
rHuEPO monotherapy group
rHuEPO was administrated during hospitalization period.
干预措施: rHuEPO (Drug)
iron sucrose monotherapy group
Iron sucrose was administrated during hospitalization period.
干预措施: Iron sucrose (Drug)
rHuEPO combined with iron sucrose group
rHuEPO combined with iron sucrose was administrated during hospitalization period.
干预措施: rHuEPO (Drug)
rHuEPO combined with iron sucrose group
rHuEPO combined with iron sucrose was administrated during hospitalization period.
干预措施: Iron sucrose (Drug)
结局指标
主要结局
Differences in changes of Hb level in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.
时间窗: Operation day to postoperative day 7
Changes of Hb level =Hb level in postoperative 7d - Hb level in operation day
次要结局
- Comparing differences of blood loss volume in each group.(Operation day to postoperative day 7)
- Safety of rHuEPO and/or iron sucrose(Form operation day to postoperative day 7)
- Differences in change of hematokrit (HCT) in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.(Operation day to postoperative day 7)
- Differences in change of allogeneic transfusion rate(%) in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.(Operation day to postoperative day 7)
- Differences in change of allogeneic blood transfusion volume in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.(Operation day to postoperative day 7)
- Differences in change of red blood cells count(RBC) in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.(Operation day to postoperative day 7)
- Difference in postoperative hospital days in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.(Up to 4 months)
- Differences in changes of platelet count in rHuEPO, iron sucrose, rHuEPO combined with iron sucrose and control group.(Operation day to postoperative day 7)
- Comparing the rate of anemia between operation day and post-operation day 7 in each group.(Operation day to postoperation day 7)
研究者
Wei Wang, MD & PhD
Clinical Professor
Peking Union Medical College Hospital