View clinical trials related to Ex Vivo Lung Perfusion.
Filter by:Lung transplantation is a life-saving and life-prolonging therapy for patients with end-stage lung disease. However, the number of patients listed for lung transplantation exceeds the number of available donor lungs, leading to long wait times, deterioration in health and death of some listed patients. One way to address this issue is to reduce the number of donor lungs that are deemed unusable (declined) for transplantation. Often, donor lungs are declined for transplantation based on questionable function or inability to fully assess the organ in the donor. Due to this reason, up to 80% of potentially suitable lungs may be discarded. As a result, ex vivo lung perfusion (EVLP) was developed. EVLP is a technique that enables the donor lungs to function in near physiological conditions outside the body, allowing surgeons to evaluate the suitability of the donor lungs for transplantation. Using this technique, centers have reported the recovery of around 70% of donor lungs that would have otherwise been deemed unusable and discarded. The first generation Toronto EVLP technique started as a clinical trial in 2008 and became a part of the clinical standard of care at Toronto General Hospital in 2011. Since then, many clinical studies have shown that short- and long-term outcomes of recipients who received donor lungs assessed by the Toronto EVLP system were similar to those who received donor lungs deemed suitable to go straight to transplantation. In partnership with Traferox Technologies Inc., surgeons and research team members developed the second generation TorEx Lung Perfusion System, which addresses engineering design limitations of the original Toronto EVLP system. It optimizes the Toronto EVLP technique by combining all the necessary equipment required to perform the procedure, while placing their controls within a central location. The technique of perfusion and ventilation as well as the perfusate solution remain the same between the two EVLP systems. Prior to this study, the TorEx Lung Perfusion System has not been used in clinical human lung transplantation. The first purpose of this study is to look at the safety of using the TorEx Lung Perfusion System in 20 consented recipients. The second purpose to compare post-transplant outcomes between recipients who received donor lungs assessed by the TorEx Lung Perfusion System and a historical cohort of recipients who received donor lungs that were assessed by the first generation Toronto EVLP system.
Ex Vivo Lung Perfusion (EVLP) appears to be an effective strategy to expand the lung donor pool by better evaluation and reconditioning of non standard grafts. Today, EVLP is clinical practice at the most active transplant centers in North America and Europe. The aim of this observational prospective monocentric study is to prove the safety and efficacy of EVLP performed in the setting of Bergamo lung transplant program. A statistically estimated sample size would not fit with the small numbers of Italian lung transplant activity, so the investigators decided to enrol 10 consecutive recipients of grafts subjected to EVLP. Non standard grafts from Brain Dead Donors (BDD) and Donors after Cardiac Death (DCD) and standard grafts that will undergo prolonged cold ischemic time will be selected for EVLP. The donor lung procurement operation will be done in the usual manner. The EVLP procedure will be performed in the operating theater of Papa Giovanni XXIII Hospital. The investigators decided to adopt Toronto protocol since it involves some lung protective strategies. EVLP will proceed over a period of at least 4 and not more than 6 hours. After 60, 120, 180 and 240 minutes from the start of EVLP the following parameters will be evaluated: - ratio of the partial pressure of arterial oxygen to fraction of inspired oxygen (PO2/FiO2, mmHg) - Pulmonary Vascular Resistance (PVR, dine*s/cm5) - Peak Inspiratory Pressure (PIP, cmH2O) and mean airways Pressure (Pawm, cmH2O) - dynamic lung Compliance (Cpldyn, ml/ cmH2O) - ΔPO2 = pulmonary vein PO2 - pulmonary artery PO2 (mmHg). Moreover, after 60 and 240 minutes from the start of EVLP a graft X-ray and a bronchoscopy will be performed. The lung graft will be accepted for transplantation if, after 240 minutes from the start of EVLP, the following conditions are fulfilled: - PO2/FiO2 >350 mmHg - stability or reduction of PVR compared with the measurement at the baseline assessment time point - stability or reduction of PIP and Pawm compared with the measurement at the baseline assessment time point - stable or better Cpldyn compared with the measurement at the baseline assessment time point - ΔPO2 >400 mmHg - improvement of X-ray imaging compared with that at the baseline assessment time point - exclusion of oedema and purulent secretions by bronchoscopy. After transplantation the recipients will be followed-up for 1 year according to a scheduled timetable. Data about the EVLP and transplant procedure and about the characteristics of donors and recipients will be collected in a dedicated electronic Case report form (eCRF) according to Good Clinical Practice.