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The OCS Lung EXPAND Trial is a prospective, international trial to assess the short and long-term clinical outcomes after lung transplantation of extended criteria donor lungs that were preserved, recruited and assessed using the OCS Lung portable EVLP system.
The OCS Lung EXPAND trial donor Inclusion Criteria: age ≥55; or Donor PaO2/FiO2 ≤ 300 mmHg; or Expected ischemic time > 6 hours; or Donor after Cardiac Death (DCD donor). Recipient Inclusion Criteria: age ≥ 18 years old; registered male or female primary double lung transplant candidate; & signed written informed consent for the trial. Donor Exclusion Criteria: positive serology; presence of moderate to severe traumatic lung injury; & presence of confirmed active pneumonia; previous history of pulmonary disease; multiple transfusions of >10 pRBCs units; ABO incompatibility; and tobacco history of >20 packs per year. Recipient Exclusion Criteria: prior solid organ or bone marrow transplant; single lung recipient; chronic use of renal dialysis or diagnosed of chronic renal dysfunction.
Endpoints: Short-Term y study endpoints are patient survival at day 30 post-transplantation, freedom from ISHLT Primary Graft Dysfunction (PGD) Grade 3 post-transplantation, and donor lung utilization rate.
Mid-Term Endpoints: patient survival at 6 months, and incidence of lung graft related serious adverse events (bronchial complications, pulmonary infection, pulmonary failure and rejection).