Table 1 Primary and secondary outcomes for the BOLD study
Type of outcome | Outcome | Definition |
|---|---|---|
Primary | Donor oxygenation | Change in the PaO2/FiO2 ratio as measured by arterial blood gas analysis from enrollment to organ procurement or 72 hours, whichever occurs first |
Secondary clinical | Donor lung utilization rate | The number of lungs transplanted divided by the total number of lungs available in the donors enrolled in each study arm. The donor utilization rate will also be evaluated using only potentially transplantable lungs in the denominator. For this analysis, donors whose lungs have absolute contraindications to transplantation will not excluded including donors with (1) significant pulmonary disease, (2) bilateral lung contusion, (3) hepatitis C antibody positive (4) age over 65 years or (5) HIV positive. |
| Â | Static lung compliance | Change in static lung compliance between enrollment and organ procurement or 72 hours, whichever occurs first. During study enrollment, static lung compliance is measured every 12 hours and immediately prior to organ procurement. |
| Â | Chest radiographic score | Change in chest radiographic pulmonary edema score between enrollment radiograph and radiograph obtained just prior to organ procurement. Chest radiographs are scored in a blinded fashion by two of the investigators using a scoring system developed and validated specifically for this study [29]. |
Secondary physiological (only in lungs that are not used for transplantation) | Lung wet-to-dry weight ratio | Gravimetric measurement of the ratio of the wet weight compared to the lung weight after drying. The lung wet-to-dry weight ratio is a quantitative index of the degree of pulmonary edema [17]. Total lung weight will also be measured. |
| Â | Rate of alveolar fluid clearance | The rate of alveolar fluid clearance is measured in a rewarmed lobe of the excised lung after instillation of an isotonic albumin-containing solution [17] |
Secondary recipient (only in lung transplant recipients) | 30-day lung graft survival | Percent of lung allografts that are functional 30 days after transplantation in each study arm |
| Â | 30-day lung recipient survival | Percent of lung transplant recipients that are alive at 30 days after transplantation in each study arm |