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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03376074
Recruitment Status : Completed
First Posted : December 18, 2017
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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

Condition or disease Intervention/treatment Phase
Hepatocellular Injury Device: Hypothermic oxygenated perfusion (HOPE) Other: Conventional cold storage Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interest of Oxygenated Hypothermic Perfusion in Preservation of Hepatic Grafts From Expanded Criteria Donors. A Prospective Monocentric Study.
Actual Study Start Date : February 19, 2018
Actual Primary Completion Date : February 7, 2019
Actual Study Completion Date : February 7, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
Experimental: Hypothermic oxygenated perfusion (HOPE)
Application of HOPE for 2 hours
Device: Hypothermic oxygenated perfusion (HOPE)
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

Active Comparator: Conventional cold storage Other: Conventional cold storage
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 Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376074


Locations
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France
CHU de Rennes
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03376074    
Other Study ID Numbers: 35RC16_9792_PERPHO
2017-A00085-48 ( Other Identifier: ID-RCB number )
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rennes University Hospital:
liver transplantation
hypothermic machine liver perfusion
extended criteria liver grafts
Additional relevant MeSH terms:
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Hypothermia
Body Temperature Changes
Signs and Symptoms