Lung Transplantation Clinical Trial
Official title:
Normothermic Ex Vivo Lung Perfusion (EVLP) For An Improved Assessment of Donor Lungs For Transplantation
The use of ex vivo lung perfusion (EVLP) will allow for a secondary evaluation technique for donor lungs that fail to meet standard acceptability criteria. This advanced assessment might lead to increased utilization rates of donor lungs and improved outcomes after lung transplantation.
Human donor lungs that do not meet the standard clinical criteria for donor lung utilization
but fit into the study inclusion criteria will be retrieved from the donor using current
donor lung retrieval techniques.
These lungs will be brought to the study transplant center to be re-assessed by the
transplant team. The lungs will be physiologically assessed during ex vivo perfusion with
Steen Solution. Perfusion of these lungs will be performed using Steen solution with the
addition of methylprednisolone, heparin and antibiotics. With respect to the decision of
lung utilization those organs with a delta pO2 (Δ pO2 = Pulmonary vein pO2 - pulmonary
artery pO2) during ex vivo perfusion assessment > 350mmHg, good lung compliance, and a
favorable opinion of the transplant surgeon will be considered transplantable. Lungs will be
excluded for transplantation: if the Δ pO2 is less than 350mmHg or if they demonstrate >10%
deterioration in any of the following functional parameters: pulmonary vascular resistance
(PVR), dynamic compliance or airway pressures. Lungs will also be excluded if they are
deemed unsuitable based on the clinical judgment of the lung transplant surgeon.
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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