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Post-Static Cold Storage Hypothermic Oxygenated Perfusion in Bergamo Liver Transplant Program

Sponsored by Papa Giovanni XXIII Hospital

About this trial

Last updated 6 years ago

Study ID

Post-SCS Liver HOPE Bg

Status

Unknown status

Type

Observational

Placebo

No

Accepting

18-75 Years
30 to 70 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 4 years ago

What is this trial about?

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.

What are the Participation Requirements?

Grafts inclusion criteria:

- extended criteria BDD with a mix of the following: age ≥70 years, liver macrosteatosis
≥35%, anti-Hepatitis C Virus (HCV) positivity, Hepatitis B surface Antigen (HBsAg)
positivity, hemodynamic instability

- DCD donors category IVB (on ExtraCorporeal Membrane Oxygenation (ECMO) support) with a
mix of the above-mentioned characteristics and/or with undetermined hepatocellular
necrosis

- DCD donors category I-IVA on normothermic regional ECMO support

- different donors characteristics from the above-mentioned ones but organisational
set-up including prolonged total ischemic time.

Grafts exclusion criteria: living donors.

Recipients' inclusion criteria:

- liver transplant candidates who are going to be transplanted with a graft preserved by
post-SCS HOPE

- liver transplant candidates who consent to participate in the study by signing the
informed consent form.

Recipients' exclusion criteria:

- liver transplant candidates who are going to be transplanted with a graft preserved by
SCS

- liver transplant candidates who are going to be transplanted with a graft preserved by
post-SCS HOPE but refuse consent for their participation in the study.