Effect of Pexelizumab on All-Cause Mortality and Myocardial Infarction in Patients Undergoing Coronary Artery Bypass Graft Surgery With Cardio-Pulmonary Bypass

Exclusion Criteria

• •has planned aortic dissection repair and/or requires aortic root reconstruction;
• •requires salvage intervention as defined by the ACC/AHA guidelines as being ongoing cardiopulmonary resuscitation on the way to the operating room;
• •has current cardiogenic shock, acute left ventricular rupture, acute septal rupture or acute papillary muscle rupture;
• •has uncontrolled diabetes, defined as a documented plasma blood glucose value \> 400 mg/dl (22.2 mmol/L) within three (3) days before surgery;
• •has a history of renal failure and a serum creatinine value greater than 3.0 mg/dl;
• •has a history of chronic hepatic failure and/or hepatic cirrhosis;
• •has a history of malignancy, excepting basal cell carcinoma and malignancies in remission (greater than 2 years);
• •has any active bacterial or other infection which is clinically significant, in the opinion of the investigator (e.g. evaluate the evidence based on WBC, temperature, cultures, etc. as appropriate for the patient);
• •has any serious medical condition which, in the opinion of the investigator is likely to alter the patient's course of recovery or the evaluation of the study medication's safety;
• •has a history of alcohol or drug abuse within the past year;
• •has a known or suspected hereditary complement deficiency;
• •has participated in any other investigational drug study or was exposed to an investigational agent or device within 30 days of randomization;
• •is receiving, or is planning to receive, any other investigational drug or device, or will participate in any other research study during the trial;
• •is pregnant or breast-feeding.