EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)

Exclusion Criteria

• •Over the age of 64 years
• •Patients who receive allogeneic transfusion 60 days prior to surgery
• •Hgb \> 15g/dl
• •Patients who are pregnant or currently lactating
• •Women of childbearing potential (e.g. those not surgically sterilized or not post-menopausal) must use 2 methods of contraception including at least one barrier method.
• •End-stage renal disease requiring renal replacement therapy or dialysis
• •Hepatic dysfunction (defined as total bilirubin value \> 1.5 mg/dl)
• •Off-pump (no CPB) cardiac surgery
• •Emergency surgical procedure
• •Inability to receive blood products
• •Endocarditis as defined my Modified Duke Criteria
• •Any congenital coagulation disorder
• •Chronic anemia (defined as preoperative Hgb concentration \< 10 g/dl)
• •Low platelet count (defined as preoperative platelet count less than 150 x 103/μl)
• •Not a surgical candidate due to high risk of morbidity or mortality
• •Surgery for aneurysm repair, dissection, or other thoracic aortic procedure
• •Congenital heart surgery
• •Cardiogenic shock or hemodynamic instability within 24 hours prior to surgery, as defined by systolic blood pressure \< 80 mmHg and heart rate \> 120 beats per minute
• •Known malignancy within the past 5 years
• •Life expectancy \< 12 months
• •Current active infection requiring antibiotic treatment
• •Inability to comply with study protocol
• •Contraindication to Epogen
• •Hypersensitivity to epoetin or any component of the formulation
• •Pure red cell aplasia (due to epoetin or other epoetin protein drugs)
• •Contraindication to Ferrous Sulfate
• •Hypersensitivity to iron salts or any component of the formulation
• •Hemochromatosis
• •Hemolytic anemia
• •In the opinion of the Principle Investigator (PI) any specific disease process or confounding variables that may inappropriately alter the outcome of the study