Efficacy and Safety Study on bIAP

Inclusion criteria

• Male or non-pregnant, non-lactating female patients of any race in the ages of >18 years. Women must be of non-childbearing potential.
• Patients scheduled for coronary artery bypass surgery with CPB.
• Patients must have a EuroSCORE (Appendix I) of >2 and <6.
• Patients who have given written informed consent prior to participation in the trial and who undertake to comply with the protocol.

Exclusion criteria

• Patients who are unwilling or unable to be fully evaluated for follow-up.
• Patients who undergo CABG for emergency due to complications from percutaneous transluminal coronary angioplasty (PTCA)/ catheterization, unstable angina or ongoing myocardial infarction.
• Patients who have base alkaline phosphatase levels at > 100 IU/l (70 IU/L as mean concentration) levels, or levels < 30 IUnits/L (ammediol, DEA units)

(values base levels in glycine units at pH9.6 and 25 C are respectively >40 and < 12 IU/L).

• Patients who show pre-operative infections or who are suspected of having endocarditis or systemic infection.
• Patients who refuse to accept medically-indicated blood products.
• Patients who have evidence of significant hepatic disease, including history of clinical signs or laboratory values of total bilirubin > 2.0 mg/dL, ALT or AST> 3X upper limit of normal.
• Patients who received investigational drugs in the 30 days prior to study drug administration, or are currently participating in a study during which the administration of investigational drugs within one month is anticipated.
• Patients who require pre-operative ventilatory support.
• Patients who have renal insufficiency (history of creatinine> 2.0 mg/dL) or chronic renal failure requiring dialysis.
• Patients who are planned to receive leukocyte-depletion filtration as part of the bypass circuitry.
• Patients with severe neurological deficits (see Appendix I).
• Patients who have a recent history of substance or alcohol abuse.
• Patients with a diagnosis of idiopathic thrombocytopenia.
• Concomitant surgical procedures (i.e., not included in Appendix VI) anticipated to require greater than 2.5 hours time "on-pump" or patients for whom surgery other than coronary artery bypass surgery is planned during the 30-day study period.
• Patients with a history of cancer who have received chemotherapy or radiation therapy within the past 3 months. Patients receiving only adjuvant hormonal therapy are not excluded. If the cancer has not resolved completely, the patient should not be enrolled without permission of Alloksys.
• Patients who are scheduled to receive "stress doses" of glucocorticoids (i.e., doses >2 mg/kg/day of methylprednisolone or equivalent) prior to, during or following the operation.
• Patients who are vegetarians or vegenists or those patients that may be expected not to be tolerant for bovine proteins.
• Patients who have a BMI (body mass index) < 18 or > 30
• Patients who are, in the opinion of the Investigator or the Sponsor, unsuitable for the study.