Safety and Efficacy of Treprostinil in Ischemia and Reperfusion Injury in Adult Orthotopic Liver Transplantation

Exclusion Criteria

• •Subjects must not:
• •1. Be receiving a living donor liver transplant.
• •2. Be receiving a donor liver with a cold ischemia time less than 5 hours or greater than 12 hours.
• •3. Be receiving any investigational drug (a drug other than Treprostinil administered under an IND) or participating in any other investigational study, with the exception of alemtuzumab (Campath).
• •4. Be receiving any prostanoid to treat portopulmonary hypertension.
• •5. Have had a failed liver transplant within the previous 180 days.
• •6. Be undergoing multi-organ transplantation (transplantation of organs other than liver at the same time as the liver transplantation procedure).
• •7. Have fulminant hepatic failure
• •8. Model for end stage liver diseases (MELD) score of \> 40
• •9. Hepatitis C positive donor liver
• •10. On renal replacement therapy at the time of study
• •11. Be receiving any non-standard immunosuppression protocol or other non-standard treatment that could affect interpretation of the study results.
• •12. Those currently receiving treatment for portopulmonary hypertension.
• •13. Those with significant cardiovascular disease including treatment with inotropes.
• •14. Have any known hypersensitivity to prostaglandins, prostacyclin or treprostinil.
• •15. If female, be pregnant or nursing (as confirmed by urine pregnancy test at Baseline).
• •16. HIV positive
• •17. Individuals who are allergic to iodine
• •18. Individuals who are receiving methylene blue
• •19. A donor liver with macrosteatosis greater than 40% if biopsy results are available