Repertaxin in Prevention of Primary Graft Dysfunction After Lung Transplantation

Exclusion Criteria

• •Recipients of an intended multiple organ transplant, including heart-lung and liver-lung transplantation;
• •Recipients of a lung from a living lobar donor;
• •Recipients of a lung from a non-heart beating donor;
• •Re-do lung transplantation;
• •Recipients requiring mechanical ventilation at the time of transplant;
• •Recipients with an extra-respiratory tract site of infection (positive blood culture(s) and/or fever associated with other signs of systemic sepsis syndrome). The criterion was not meant to exclude bacteraemic cystic fibrosis patients with or without fever, unless they presented with other signs of sepsis;
• •Recipients with hepatic dysfunction (bilirubin exceeding 3 mg/dL and/or transaminases \>3X upper limit of normal \[ULN\]) at the time of transplant;
• •Hypersensitivity to:
• •* Ibuprofen or to more than one non steroidal anti-inflammatory drug (NSAID);
• •* Medications belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib;
• •Patients simultaneously participating in any other studies involving a study drug to be administered concomitantly with the investigational product and/or a study drug intended to prevent ischemia/reperfusion injury;
• •Planned use of anli-CD3 monoclonal antibody (Orthoclone OKT3) or alemtuzumab (Campath) induction immunosuppression;
• •Planned use of sirolimus in the first 3 months after transplantation;
• •Pregnant or breast-feeding women (NB: pregnancy was lo be avoided in patients or partners during the first month of participation in the study; no other specific warnings were described, considering even stricter general recommendations concerning pregnancy in transplanted patients, the treatment course of the investigational product, its pharmacokinetic profile, and the lack of significant adverse effects on mating performance and fertility in animal studies).