Ignite Creation Date:
2024-05-06 @ 9:43 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03053349
Status:
COMPLETED
Last Update Posted:
2023-05-23
First Post:
2017-02-09
Brief Title:
Ex Vivo Lung Perfusion in Bergamo Lung Transplant Program
Sponsor:
Papa Giovanni XXIII Hospital
Organization:
Papa Giovanni XXIII Hospital
Study Overview
Official Title:
Ex Vivo Lung Perfusion in Bergamo Lung Transplant Program A Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 PO2FiO2 mmHg
Pulmonary Vascular Resistance PVR dinescm5
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
PO2FiO2 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
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 PO2FiO2 mmHg
Pulmonary Vascular Resistance PVR dinescm5
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
PO2FiO2 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
Detailed Description:
Ex Vivo Lung Perfusion EVLP has been allowing to expand the lung donor pool by better evaluation and reconditioning of non standard grafts The results of both completed and still recruiting prospective clinical trials show similar short- and long-term post-transplant outcomes with non standard and standard grafts subjected to EVLP and traditionally preserved 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 Grafts from donors over the age of 65 andor with a smocking history of more than 10 pack-year andor with chronic lung disease andor with gross gastric aspiration andor with a diagnosis of established pneumonia will be rejected
The donor lung procurement operation will be done in the usual manner After excision the right and left graft will not be divided and will be packed in ice for transportation
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
PO2FiO2 mmHg
Pulmonary Vascular Resistance PVR dinescm5
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
PO2FiO2 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 If the lung graft is considered suitable for transplantation the EVLP procedure will be stopped as described by Toronto protocol and the right and left graft will be divided and packed for hypothermic preservation until implantation
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
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 Grafts from donors over the age of 65 andor with a smocking history of more than 10 pack-year andor with chronic lung disease andor with gross gastric aspiration andor with a diagnosis of established pneumonia will be rejected
The donor lung procurement operation will be done in the usual manner After excision the right and left graft will not be divided and will be packed in ice for transportation
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
PO2FiO2 mmHg
Pulmonary Vascular Resistance PVR dinescm5
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
PO2FiO2 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 If the lung graft is considered suitable for transplantation the EVLP procedure will be stopped as described by Toronto protocol and the right and left graft will be divided and packed for hypothermic preservation until implantation
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None