Study of the Use of a Single Dose of Erythropoietin to Treat Acute Myocardial Ischemia (DREAM)

Inclusion Criteria:

• Before any study-specific procedure, including assessments for screening, the appropriate written informed consent must be obtained.
• Man or woman 18 to 80 years of age .
• Undergoing a planned, elective cardiopulmonary bypass operation for the first time for 3-vessel coronary artery disease with an anticipated aortic cross clamp time of approximately 40 minutes and a total bypass time of approximately 90 minutes.
• Hemoglobin (Hb) concentration ≥7.4 mmol/l and ≤9.9 mmol/l within 7 days prior to CABG surgery and no major acute blood loss since this Hb determination.

Exclusion Criteria:

• An unstable medical condition, defined as having been hospitalized for a non-cardiac condition within 4 weeks of screening, major surgery within 24 weeks of screening, or otherwise unstable in the judgment of the investigator (e.g., at risk of complications or adverse events unrelated to study participation).
• Left ventricular ejection fraction (LVEF) < 40%.
• Clinical history of chronic kidney disease (CKD) (at any point prior to registration) defined as serum creatinine >105 μmol/l for all females, >130 μmol/l for black males, and >115 μmol/l for non-black males.
• Atrial fibrillation, paroxysmal atrial fibrillation or atrial flutter.
• Clinically significant abnormality in chemistry, hematology, or urinalysis parameters performed within the screening period.
• Current symptoms of polyurea, polydipsia, or increased thirst.
• Grand mal seizure within 1 year of enrollment.
• Poorly controlled hypertension, defined as systolic blood pressure (SBP) > 180 mmHg or diastolic blood pressure (DBP) > 105 mmHg on day of CABG surgery.
• Use of any erythropoietic protein (e.g., rHuEPO; Procrit®, Eprex®, Neorecormon®, Epogen®, Aranesp®) within 12 weeks of enrolment.
• Positive pregnancy test or known to be pregnant at the time of screening.
• Recent (within 3 months) history of alcohol or illicit drug abuse disorder, based on self-report.
• Severe uncorrected valvular disease (including pulmonary and tricuspid) or left ventricular outflow obstruction which, in the opinion of the investigator, requires surgery.
• Pulmonary hypertension, defined as a pulmonary artery pressure > 30 mmHg at rest.
• Participation in any investigational device or drug trial(s) or receiving other investigational agent(s) within 30 days.
• Known positive for HIV antibodies, hepatitis B surface antigen, or hepatitis C antibodies.
• Any condition (e.g., unsuitable anatomy of the atrium; psychiatric illness; etc.) or situation that, in the investigator's opinion, could put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.