Interest of Oxygenated Hypothermic Perfusion (PHO) in Preservation of Hepatic Grafts From Expanded Criteria Donors (PERPHO)

Rennes University Hospital

Status: Completed

Conditions: Hepatocellular Injury

Treatments: Device: Hypothermic oxygenated perfusion (HOPE); Other: Conventional cold storage

Study type: Interventional

Funder types: Other

Identifiers

NCT03376074

35RC16_9792_PERPHO

2017-A00085-48 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Hypothermic oxygenated perfusion (HOPE)

Experimental group

Description:

Application of HOPE for 2 hours

Treatment:

Device: Hypothermic oxygenated perfusion (HOPE)

Conventional cold storage

Active Comparator group

Treatment:

Other: Conventional cold storage