Clinical trial NCT03376074: Interest of Oxygenated Hypothermic Perfusion (PHO) in Preservation of Hepatic Grafts From Expanded Criteria Donors
Official title: Interest of Oxygenated Hypothermic Perfusion in Preservation of Hepatic Grafts From Expanded Criteria Donors. A Prospective Monocentric Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Injury
Keywords: liver transplantation
hypothermic machine liver perfusion
extended criteria liver grafts
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Interest of oxygenated hypothermic perfusion in preservation of hepatic grafts from expanded criteria donors.

Detailed description: The excellent results of liver transplantation (LT) have led to a significant increase in the number of patients awaiting transplantation. At the same time, the number of grafts remains stable. To extend the donor pool, the use of Extended Criteria Donor (ECD) donors graft increased each year despite the fact that these graft are known to be more vulnerable to ischemia-reperfusion injuries induced by cold storage preservation (CS). Their use is therefore associated with a greater risk of postoperative dysfunction of the graft. This risk can be reduced by improving preservation quality.

The preservation by hypothermic oxygenated perfusion (HOPE) consists of keeping the graft in hypothermia (4 to 12 °C) on an machine perfusion (MP) using a specific solution, saturated with oxygen. In kidney transplantation, the use of MP has been shown to improve graft function as well as graft survival, especially for ECD grafts.

In liver transplantation, experimental studies on animal models have demonstrated the superiority of HOPE over CS regarding graft function and survival. These results have been confirmed in humans on small retrospective series.

As HOPE is an expensive procedure, obtaining evidence of its effectiveness could result in a reimbursement of the additional cost.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years
* Candidates for a first orthotopic liver transplantation, without transplantation of another associated organ (kidney, pancreas, heart, lung, intestine)
* With cirrhosis whatever its etiology and gravity
* With or without hepatocarcinoma
* Having given free, informed and written consent
* LT made from a whole graft, harvested from a brain-dead donor with ECD criteria, defined as the presence of at least one of the following criteria:

  * Age\> 65 years
  * BMI\> 30 kg / m2
  * Duration of hospitalization in intensive care unit\> 7 days
  * Natremia\> 155 mmol / l
  * AST\> 150 IU / ml
  * ALT\> 170 IU / ml
  * Occurrence of cardiac arrest before harvesting
  * Macrovacuolar steatosis\> 30% on liver histology

Exclusion Criteria:

* History of organ transplantation
* Transplantation in emergency
* Transplantation from a living donor, a reduced graft or a graft from a deceased donor by cardiac arrest (DCD)
* Major persons subject to legal protection (safeguard of justice, guardianship), persons deprived of their liberty

Primary outcomes:
measure: Evaluation of the performance of HOPE in the preservation of ECD liver grafts on graft function recovery
timeFrame: Day 7
Secondary outcomes:
measure: Evaluation of the impact of PHO during the conservation of ECD liver grafts on intraoperative morbidity
timeFrame: Day 1
measure: Evaluation of the impact of PHO during the conservation of ECD liver grafts on intraoperative morbidity
timeFrame: Day 1
measure: Evaluation of the impact of PHO during the conservation of ECD liver grafts on postoperative morbidity
timeFrame: Day 7
measure: Evaluation of graft's survival
timeFrame: Month 3
measure: Number of days of hospitalization (initial stay) after transplantation
timeFrame: Postoperative course
measure: Number of days of hospitalization after transplantation
timeFrame: Month 3
measure: Cost of the initial stay
timeFrame: Postoperative course
measure: Cost of the hospitalization stay
timeFrame: Month 3
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References:
citation: Rayar M, Beaurepaire JM, Bajeux E, Hamonic S, Renard T, Locher C, Desfourneaux V, Merdrignac A, Bergeat D, Lakehal M, Sulpice L, Houssel-Debry P, Jezequel C, Camus C, Bardou-Jacquet E, Meunier B. Hypothermic Oxygenated Perfusion Improves Extended Criteria Donor Liver Graft Function and Reduces Duration of Hospitalization Without Extra Cost: The PERPHO Study. Liver Transpl. 2021 Feb;27(3):349-362. doi: 10.1002/lt.25955.