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

Not Applicable

Completed

• Conditions: Hepatocellular Injury
• Interventions: Other: Conventional cold storage; Device: Hypothermic oxygenated perfusion (HOPE)

• Registration Number: NCT03376074
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-18
• Study Start: 2018-02-19
• Status Verified: 2019-02
• Primary Completion: 2019-02-07
• Study Completion: 2019-02-07
• Last Update Submitted: 2019-03-08
• Last Update Posted: 2019-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional cold storage	Conventional cold storage	-
Hypothermic oxygenated perfusion (HOPE)	Hypothermic oxygenated perfusion (HOPE)	Application of HOPE for 2 hours

Primary Outcome Measures

Name	Time	Method
Evaluation of the performance of HOPE in the preservation of ECD liver grafts on graft function recovery	Day 7	Occurrence of early allograft dysfunction and / or primary non function

Secondary Outcome Measures

Name	Time	Method
Evaluation of the impact of PHO during the conservation of ECD liver grafts on intraoperative morbidity	Day 1	Incidence of reperfusion syndrome defined as a 30 % decrease of mean arterial pressure, for at least 1 minute, during the 5 minutes following revascularization
Evaluation of the impact of PHO during the conservation of ECD liver grafts on postoperative morbidity	Day 7
Evaluation of graft's survival	Month 3	Occurrence of a vascular and biliary complication
Number of days of hospitalization (initial stay) after transplantation	Postoperative course
Cost of the initial stay	Postoperative course
Cost of the hospitalization stay	Month 3
Number of days of hospitalization after transplantation	Month 3

Trial Locations

Locations (1)

CHU de Rennes; 🇫🇷 Rennes, France