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Completed

NCT Number: NCT03376074

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

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

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Key information

Age range

18 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Rennes

Rennes, 35033, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypothermic oxygenated perfusion (HOPE)

Device

25 patients: Application of HOPE for 2 hours, perfusion rate 100-150 ml/min, pressure controlled, perfusion pressure < 3 mm Hg, perfusion route portal vein, recirculating system, perfusion volume 2 L, perfusate solution (UWMP®), perfusate temperature 4-12 °C, perfusate oxygenation 40 KPa

Conventional cold storage

Other

75 patients transplanted in Rennes between 2010 and 2015 with a cold stored grafts, matched (ratio 1: 3) using a propensity score calculated according to some parameters

Primary outcomes

  1. Evaluation of the performance of HOPE in the preservation of ECD liver grafts on graft function recovery

    Time frame: Day 7

    Occurrence of early allograft dysfunction and / or primary non function

Secondary outcomes

  1. Evaluation of the impact of PHO during the conservation of ECD liver grafts on intraoperative morbidity

    Time frame: Day 1

    Number of intraoperative transfusions

  2. Evaluation of the impact of PHO during the conservation of ECD liver grafts on intraoperative morbidity

    Time frame: 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

  3. Evaluation of the impact of PHO during the conservation of ECD liver grafts on postoperative morbidity

    Time frame: Day 7

  4. Evaluation of graft's survival

    Time frame: Month 3

    Occurrence of a vascular and biliary complication

  5. Number of days of hospitalization (initial stay) after transplantation

    Time frame: Postoperative course

  6. Number of days of hospitalization after transplantation

    Time frame: Month 3

  7. Cost of the initial stay

    Time frame: Postoperative course

  8. Cost of the hospitalization stay

    Time frame: Month 3

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

Interest of Oxygenated Hypothermic Perfusion in Preservation of Hepatic Grafts From Expanded Criteria Donors. A Prospective Monocentric Study.

Acronym: PERPHO

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 18, 2017
Registry last updated
Mar 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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