Interest of oxygenated hypothermic perfusion in preservation of hepatic grafts from expanded criteria donors.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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
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
CHU de Rennes
Rennes, France
Evaluation of the performance of HOPE in the preservation of ECD liver grafts on graft function recovery
Occurrence of early allograft dysfunction and / or primary non function
Time frame: Day 7
Evaluation of the impact of PHO during the conservation of ECD liver grafts on intraoperative morbidity
Number of intraoperative transfusions
Time frame: Day 1
Evaluation of the impact of PHO during the conservation of ECD liver grafts on intraoperative morbidity
Incidence of reperfusion syndrome defined as a 30 % decrease of mean arterial pressure, for at least 1 minute, during the 5 minutes following revascularization
Time frame: Day 1
Evaluation of the impact of PHO during the conservation of ECD liver grafts on postoperative morbidity
Time frame: Day 7
Evaluation of graft's survival
Occurrence of a vascular and biliary complication
Time frame: Month 3
Number of days of hospitalization (initial stay) after transplantation
Time frame: Postoperative course
Number of days of hospitalization after transplantation
Time frame: Month 3
Cost of the initial stay
Time frame: Postoperative course
Cost of the hospitalization stay
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Time frame: Month 3