Sponsor study identifier
observational
20
1 country
1
Study Start
November 5, 2017
Actual (reported)Primary Completion
December 3, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 3, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 3, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 26, 2017
Actual (reported)March 31, 2017
Actual (reported)November 5, 2017
Actual (reported)December 3, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 3, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Incidence of early allograft dysfunction (safety endpoint)
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
Post-operative day 7
Rate of complications grade ≥IIIa
1 year after transplantation
Incidence of ischemic cholangiopathy
6 months after transplantation
Length of intensive care unit and hospital stay
1 year after transplantation
30-day patient survival
Post-operative day 30
30-day graft survival
Post-operative day 30
All the patients on the waiting list for liver transplantation at Bergamo transplant centre, except for those who are candidates to combined en bloc liver and pancreas transplantation
Papa Giovanni XXIII Hospital
Bergamo, 24127, Italy
Stefania Camagni, MD
Papa Giovanni XXIII Hospital
Michele Colledan, MD
Papa Giovanni XXIII Hospital
First Submitted
March 26, 2017
First Posted
March 31, 2017
Study Start
November 5, 2017
Actual (reported)Primary Completion
December 3, 2021
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 3, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 26, 2019
Record last verified: 2019-11
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Source: ClinicalTrials.gov.
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