VentaProst Versus Conventionally-Administered Aerosolized Epoprostenol in Patients Undergoing Cardiac Surgery With CPB

Exclusion Criteria

• •1. Current smoker (i.e., within the last 30 days)
• •2. Emergency operative status
• •3. Upper and/or lower respiratory tract infection within four weeks of screening
• •4. Contraindication to transesophageal echocardiogram (TEE) including esophageal disease or unstable cervical spine
• •5. Renal or severe hepatic impairment
• •6. Thromboembolic disease treated with anticoagulant therapy
• •7. Bleeding disorders
• •8. Significant restrictive or obstructive lung disease
• •9. History of concurrent malignancy or recurrence of malignancy within two years prior to Screening
• •10. History of a diagnosis of drug or alcohol dependency or abuse within approximately the last three years
• •11. Recent history of stroke or transient ischemic attack
• •12. Significantly abnormal laboratory tests at Screening
• •13. Pregnant or breastfeeding
• •14. Treatment with an investigational drug, biologic, or device within 30 days
• •15. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the patient inappropriate for entry into this trial
• •16. Any condition where aerosolized epoprostenol is contraindicated
• •17. Known allergy or sensitivity to epoprostenol, any of its ingredients, or the diluent