Ignite Creation Date:
2024-05-06 @ 9:52 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03098043
Status:
UNKNOWN
Last Update Posted:
2019-11-26
First Post:
2017-03-26
Brief Title:
Post-Static Cold Storage Hypothermic Oxygenated Perfusion in Bergamo Liver Transplant Program
Sponsor:
Papa Giovanni XXIII Hospital
Organization:
Papa Giovanni XXIII Hospital
Study Overview
Official Title:
Post-Static Cold Storage Hypothermic Oxygenated Perfusion in Bergamo Liver Transplant Program a Prospective Observational Study
Status:
UNKNOWN
Status Verified Date:
2019-11
Last Known Status:
RECRUITING
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:
In light of the widespread organ shortage dynamic preservation by means of Machine Perfusion MP has been proposed as a strategy to increase the pool of suitable grafts for liver transplantation Reproducing more physiological conditions than traditional Static Cold Storage SCS MP may allow a better preservation and evaluation and perhaps even the resuscitation of high risk grafts As a consequence unnecessary discard of organs could be avoided and quality and safety of transplantation could be improved as well
Hypothermic MP HMP seems to reduce ischemia-reperfusion injury In fact hypothermia slows down the metabolic rate and the oxygenation of the perfusate leads to re-synthesis of Adenosine TriPhosphate ATP which results in the restoration of cellular energy
Four series about the use of HMP in the clinical setting has been published so far They all report acceptable outcomes after transplantation of human liver grafts from extended criteria Brain Dead Donors BDD and from Donation after Circulatory Death DCD donors preserved by HMP thus proving its feasibility and safety The efficacy of HMP instead is still under investigation in a phase II randomized trial
This is an observational prospective monocentric study aiming at verifying the feasibility and safety of post-SCS Hypothermic Oxygenated PErfusion HOPE in the setting of our liver transplant program Extended criteria grafts from BDD and grafts from DCD donors will be preserved by post-SCS HOPE prior to transplantation The recipients of these grafts will be followed-up for at least 1 year
Hypothermic MP HMP seems to reduce ischemia-reperfusion injury In fact hypothermia slows down the metabolic rate and the oxygenation of the perfusate leads to re-synthesis of Adenosine TriPhosphate ATP which results in the restoration of cellular energy
Four series about the use of HMP in the clinical setting has been published so far They all report acceptable outcomes after transplantation of human liver grafts from extended criteria Brain Dead Donors BDD and from Donation after Circulatory Death DCD donors preserved by HMP thus proving its feasibility and safety The efficacy of HMP instead is still under investigation in a phase II randomized trial
This is an observational prospective monocentric study aiming at verifying the feasibility and safety of post-SCS Hypothermic Oxygenated PErfusion HOPE in the setting of our liver transplant program Extended criteria grafts from BDD and grafts from DCD donors will be preserved by post-SCS HOPE prior to transplantation The recipients of these grafts will be followed-up for at least 1 year
Detailed Description:
This is an observational prospective monocentric study aiming at verifying the feasibility and safety of post-SCS HOPE in the setting of our liver transplant program
20 consecutive patients with written informed consent will be enrolled They will be transplanted with grafts from extended criteria BDD or from DCD donors preserved by post-SCS HOPE
The HOPE procedure will be performed in our operating room after regular procurement transport and back-table preparation University of Wisconsin Machine Perfusion Solution UW-MPS will be used Two pumps will provide dual pressure-controlled perfusion through the portal vein and the hepatic artery Portal flow will be continuous and will be adjusted to keep portal pressure below 5 mmHg Instead arterial flow will be pulsatile and will be regulated to maintain arterial pressure between 25 mmHg and 30 mmHg The perfusate will be oxygenated with the goal of a partial Pressure of Oxygen PO2 of 50-70 kilopascal The perfusate temperature will be kept between 4C and 12C by a heat exchanger pH PO2 and partial Pressure of Carbon Dioxide PCO2 of the perfusate pumped to the graft and drained from the vena cava will be monitored HOPE will be maintained for 3 to 4 hours
Patients will be followed-up for at least 1 year according to a scheduled timetable
Data about HOPE and transplant procedure about donors and recipients characteristics and about patients follow-up will be collected in a dedicated electronic Case Report Form eCRF according to Good Clinical Practice
20 consecutive patients with written informed consent will be enrolled They will be transplanted with grafts from extended criteria BDD or from DCD donors preserved by post-SCS HOPE
The HOPE procedure will be performed in our operating room after regular procurement transport and back-table preparation University of Wisconsin Machine Perfusion Solution UW-MPS will be used Two pumps will provide dual pressure-controlled perfusion through the portal vein and the hepatic artery Portal flow will be continuous and will be adjusted to keep portal pressure below 5 mmHg Instead arterial flow will be pulsatile and will be regulated to maintain arterial pressure between 25 mmHg and 30 mmHg The perfusate will be oxygenated with the goal of a partial Pressure of Oxygen PO2 of 50-70 kilopascal The perfusate temperature will be kept between 4C and 12C by a heat exchanger pH PO2 and partial Pressure of Carbon Dioxide PCO2 of the perfusate pumped to the graft and drained from the vena cava will be monitored HOPE will be maintained for 3 to 4 hours
Patients will be followed-up for at least 1 year according to a scheduled timetable
Data about HOPE and transplant procedure about donors and recipients characteristics and about patients follow-up 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