Post-Static Cold Storage Hypothermic Oxygenated Perfusion in Bergamo Liver Transplant Program
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|ClinicalTrials.gov Identifier: NCT03098043|
Recruitment Status : Recruiting
First Posted : March 31, 2017
Last Update Posted : June 28, 2018
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.
|Condition or disease|
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 4°C and 12°C 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 Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Post-Static Cold Storage Hypothermic Oxygenated Perfusion in Bergamo Liver Transplant Program: a Prospective Observational Study|
|Actual Study Start Date :||November 5, 2017|
|Estimated Primary Completion Date :||April 3, 2020|
|Estimated Study Completion Date :||April 3, 2020|
- Incidence of early allograft dysfunction (safety endpoint) [ Time Frame: Post-operative day 7 ]Occurrence of one or more of the following: bilirubin >170 µmol/L on Post-Operative Day (POD) 7, International Normalized Ratio (INR) >1,6 on POD 7, Alanine AminoTransferase (ALT) peak >2000 U/L within the first post-operative week
- Rate of complications grade ≥IIIa [ Time Frame: 1 year after transplantation ]Dindo-Clavien classification of surgical complications
- Incidence of ischemic cholangiopathy [ Time Frame: 6 months after transplantation ]Radiological or endoscopic diagnosis of unifocal or multifocal intrahepatic strictures in the absence of any arterial complication
- Length of intensive care unit and hospital stay [ Time Frame: 1 year after transplantation ]Length of intensive care unit and hospital stay after transplantation (days)
- 30-day patient survival [ Time Frame: Post-operative day 30 ]Patient survival rate 30 days after transplantation
- 30-day graft survival [ Time Frame: Post-operative day 30 ]Graft survival rate 30 days after transplantation
- 1-year patient survival [ Time Frame: 1 year after transplantation ]Patient survival rate 1 year after transplantation
- 1-year graft survival [ Time Frame: 1 year after transplantation ]Graft survival rate 1 year after transplantation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098043
|Contact: Stefania Camagni, MDemail@example.com|
|Papa Giovanni XXIII Hospital||Recruiting|
|Bergamo, Italy, 24127|
|Contact: Stefania Camagni, MD 00390352674347 firstname.lastname@example.org|
|Principal Investigator:||Stefania Camagni, MD||Papa Giovanni XXIII Hospital|
|Study Director:||Michele Colledan, MD||Papa Giovanni XXIII Hospital|