A Study to Evaluate the Safety and Efficacy of Epoetin Alfa Versus Placebo to Reduce the Need for Blood Transfusions and Reduce the Occurrence of Severe Anemia During the Time Period Surrounding Total Hip Replacement Surgery
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of two different dosing
      schedules of epoetin alfa versus placebo for decreasing the need for blood transfusions and
      preventing the occurrence of severe anemia during the period of time around total hip
      replacement surgery. Epoetin alfa is a genetically engineered protein that stimulates red
      blood cell production.
    

Detailed description: 
      Major surgical procedures may 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 and reduce the occurrence of anemia. Epoetin alfa is a genetically
      engineered form of a natural hormone, erythropoietin, that is used to treat anemia by
      stimulating red blood cell production. This is a randomized, double-blind,
      placebo-controlled, parallel group, multicenter study in patients scheduled for total hip
      replacement surgery. This study will assess the effectiveness of epoetin alfa (starting
      either 5 or 10 days before hip replacement surgery and continuing though 3 days after
      surgery) in reducing the need for blood transfusions and the occurrence of anemia during the
      time period surrounding surgery. Hip replacement can be either the initial implant surgery or
      a second surgery on the same hip. Eligible patients will be assigned to one of three
      treatment groups. Group 1 will receive daily placebo injections under the skin for 14 days;
      Group 2 will receive a longer (14-day) course of daily epoetin alfa injections under the
      skin; and Group 3 will receive a shorter (9-day) course of daily epoetin alfa injections
      under the skin. Patients in Groups 2 and 3 will receive 300 units of epoetin alfa per
      kilogram of body weight per day in each daily injection. All patients will receive oral iron
      supplementation beginning 3 weeks prior to surgery and continuing through 1 week after
      surgery. All patients will also receive low-dose coumadin (sodium warfarin) for 7 days after
      surgery to prevent clotting in the deep veins. Effectiveness will be determined by the number
      of patients requiring transfusions and the number of patients who develop anemia (as measured
      by a hemoglobin level < 80 grams per liter). Effectiveness will also be determined by the
      total number of transfusions required, changes in red blood cell variables (hemoglobin,
      hematocrit, the number of developing red blood cells (reticulocytes), changes in the iron
      stores in the patient's blood, intensity of nursing care required, well-being assessments
      (measures of pain, shortness of breath, and energy level), and the number of days in the
      hospital after surgery. Safety evaluations will include the incidence of blood clots in the
      deep veins of the lower limbs, the incidence and severity of other adverse events, and
      changes in clinical laboratory test results and vital signs. The study hypothesis is that
      patients treated with epoetin alfa before, during, and after hip replacement surgery will
      require fewer blood transfusions and have a reduced occurrence of anemia compared with
      patients treated with placebo, and that the shorter course of epoetin alfa dosing (9 days) is
      as effective as the longer epoetin alfa course (14 days). 300 units epoetin alfa per kilogram
      (U/kg) injected under the skin 5 or 10 days before surgery, the day of surgery, and 3 days
      after surgery; or placebo injection for 14 days. Subjects receiving epoetin alfa for 5 days
      also received placebo for 5 days before starting epoetin alfa.
    

Intervention name(s): epoetin alfa
Intervention type(s): Drug
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: hip replacement; hip replacement surgery; surgery; anemia; transfusions; blood transfusions