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

Hepatocellular Injury Clinical Trial

— PERPHO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03376074
• Other study ID #: 35RC16_9792_PERPHO
• Secondary ID: 2017-A00085-48
• Status: Completed
• Phase: N/A
• Start date: February 19, 2018
• Est. completion date: February 7, 2019

Study information

• Verified date: February 2019
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 7, 2019
• Est. primary completion date: February 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatocellular Injury
• Hypothermia

Intervention

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

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

Locations

Country	Name	City	State
France	CHU de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 7
Secondary	Evaluation of the impact of PHO during the conservation of ECD liver grafts on intraoperative morbidity	Number of intraoperative transfusions	Day 1
Secondary	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	Day 1
Secondary	Evaluation of the impact of PHO during the conservation of ECD liver grafts on postoperative morbidity		Day 7
Secondary	Evaluation of graft's survival	Occurrence of a vascular and biliary complication	Month 3
Secondary	Number of days of hospitalization (initial stay) after transplantation		Postoperative course
Secondary	Number of days of hospitalization after transplantation		Month 3
Secondary	Cost of the initial stay		Postoperative course
Secondary	Cost of the hospitalization stay		Month 3