A Double-Blind, Placebo-Controlled Study to Determine the Safety of r-HuEPO and Whether r-HuEPO Can Reduce Post-Operative Transfusion Requirements in Subjects Undergoing Major Orthopedic Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1
- 主要终点
- Transfusion requirements following surgery; Changes in hematocrit, hemoglobin, and reticulocyte count from the start of the study to the end of the study
研究概览
简要总结
The purpose of this study is to determine the safety of epoetin alfa and to determine the effectiveness of epoetin alfa in reducing the need for blood transfusions after major orthopedic surgery. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.
详细描述
Patients undergoing major orthopedic surgery frequently require blood transfusions both during and after the operation. Agents that can increase the rate of red blood cell production would reduce the need for blood transfusions. Epoetin alfa is a genetically engineered form of a natural hormone, erythropoietin, that stimulates red blood cell production. This is a randomized, double-blind, placebo-controlled, parallel group, multicenter study. The study compares the effectiveness of epoetin alfa in reducing the need for blood transfusions in patients who are expected to require at least 2 units of blood following major orthopedic surgery. Eligible patients will be randomly assigned to receive either epoetin alfa (100 or 300 U/kg, depending upon their body weight) or a matching placebo, by injection beneath the skin starting 10 days before scheduled surgery, on the day of surgery (after surgery), and for 4 days after surgery. Additionally, all patients will start taking an oral iron supplement at least 10 days before their scheduled surgery. Effectiveness will be determined by the number of transfusions required following surgery, and on changes in hematocrit (iron-containing pigment in red blood cells), hemoglobin (oxygen-carrying component of red blood cells), and reticulocyte (immature red blood cells) levels from the start of the study to the end of the study. Safety evaluations will include the incidence and severity of adverse events, and changes in clinical laboratory tests, vital signs, and physical examination findings throughout the study. The study hypothesis is that patients treated with epoetin alfa will require fewer blood transfusions after surgery than patients treated with placebo. Epoetin alfa (300 U/kg or 100 U/kg), or matching placebo, by injection beneath the skin beginning 10 days before scheduled surgery and ending 4 days after surgery.
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
- •Patients scheduled for major orthopedic surgery who are expected to require transfusion of at least 2 units of red blood cells
- •who are unwilling or unable to participate in a transfusion program wherein a patient's own blood is donated before surgery
- •having no significantly abnormal blood or urine test results
- •having a hematocrit <= 45%
排除标准
- •Patients with any blood disease, significant heart and blood vessel disease or signs and symptoms of other significant disease and/or dysfunction
- •having signs and symptoms of significant and ongoing blood loss
- •having a seizure disorder, uncontrolled high blood pressure, or infections or cancers that may make it difficult to respond to the study drug
- •received medication known to suppress the formation of red blood cells within 1 month before the start of the study
- •received a blood transfusion within 1 month before the start of the study
结局指标
主要结局
Transfusion requirements following surgery; Changes in hematocrit, hemoglobin, and reticulocyte count from the start of the study to the end of the study
次要结局
- Adverse events; Changes in clinical laboratory test results, vital signs, and physical examination findings