A Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of of PROCRIT� (Epoetin Alfa) on Short-Term Outcomes in Orthopedic Subjects Undergoing Primary Unilateral Knee Arthroplasty
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 主要终点
- The primary endpoint is the change in composite FIM scores (from entry into the inpatient rehabilitation facility to discharge from inpatient rehabilitation) divided by the LOS, denoted as DFIM/LOS, or "rate of functional recovery".
研究概览
简要总结
The purpose of this study is to compare the effect of perioperative administration of PROCRIT to that of autologous blood donation on post-operative rehabilitation outcomes in patients undergoing unilateral knee surgery.
详细描述
The primary objective of this study is to compare the effect of perioperative administration of PROCRIT to that of preoperative autologous donation on post-operative rehabilitation outcomes in subjects undergoing primary unilateral knee arthroplasty.
Secondary objectives are : 1) To compare the effect of perioperative administration of PROCRIT to that of preoperative autologous donation on hemoglobin, change in hemoglobin, number of units transfused and transfusion rate during the study period; and 2) To compare the effect of perioperative administration of PROCRIT to that of preoperative autologous donation on inpatient rehabilitation length of stay.
The study will test the hypothesis that perioperative administration of PROCRIT will improve post-operative rehabilitation outcomes, compared with preoperative autologous donation. 40,000U PROCRIT or Placebo SC in relation to surgery date: Days -21, -14, -7, 0 (day of surgery), 7, and 14.
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
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
- •Scheduled for primary unilateral knee arthroplasty with an expected discharge into an inpatient rehabilitation facility
- •Hemoglobin >11 to <13 g/dL at screening and preoperative day -21
- •Age 18 years or older
- •Female subjects must be post-menopausal for at least one year or surgically sterile (hysterectomy or tubal ligation). Women of childbearing age must have negative pregnancy test(s) (serum HCG RIA at screening and urine at preoperative day -21, if applicable
- •Preoperative lead time of at least 21 days
排除标准
- •Medical conditions including: Known iron deficiency (defined as serum ferritin <50 mg/l)
- •chronic renal failure, significant hematological disease, uncontrolled hypertension, new onset seizures/uncontrolled seizures
- •Expected to need another lower extremity major joint replacement within six months
- •Undergoing cancer chemotherapy
- •History of thrombotic vascular events including but not limited to stroke, transient ischemic attack, myocardial infarction and deep venous thrombosis
结局指标
主要结局
The primary endpoint is the change in composite FIM scores (from entry into the inpatient rehabilitation facility to discharge from inpatient rehabilitation) divided by the LOS, denoted as DFIM/LOS, or "rate of functional recovery".
次要结局
- LOS in the inpatient rehabilitation facility; Total FIM score; FIM Physical Sub-score LASA score; FACIT-An score. Safety evaluations include the incidence of adverse events throughout the study