CHU de Rennes
Rennes, 35033, France
NCT Number: NCT03376074
Interest of oxygenated hypothermic perfusion in preservation of hepatic grafts from expanded criteria donors.
Looking for future studies?
Notify Me18 month and older
All sexes
Interventional
Not applicable
Rennes, 35033, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Day 7
Occurrence of early allograft dysfunction and / or primary non function
Time frame: Day 1
Number of intraoperative transfusions
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
Time frame: Day 7
Time frame: Month 3
Occurrence of a vascular and biliary complication
Time frame: Postoperative course
Time frame: Month 3
Time frame: Postoperative course
Time frame: Month 3
Rennes University Hospital
Other
Interest of Oxygenated Hypothermic Perfusion in Preservation of Hepatic Grafts From Expanded Criteria Donors. A Prospective Monocentric Study.
Acronym: PERPHO
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.
Published trials that share one or more normalized conditions with this study.
NCT01317342
Hepatocellular Injury
Zurich, Switzerland
View Trial DetailsNCT03124641
Hepatocellular Injury, Liver Transplant
Prague, Czechia
View Trial DetailsNCT01099475
Blood Loss, Hemorrhage
Maastricht, PO Box 5800, Netherlands
View Trial Details