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

NCT ID: NCT03376074

Last Updated: 2019-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-19
• Study Completion Date: 2019-02-07

Brief Summary

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

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.

Conditions

Hepatocellular Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hypothermic oxygenated perfusion (HOPE)

Application of HOPE for 2 hours

Group Type: EXPERIMENTAL

Hypothermic oxygenated perfusion (HOPE)

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Conventional cold storage

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Rennes

Rennes, , France

Countries

France

References

Rayar M, Beaurepaire JM, Bajeux E, Hamonic S, Renard T, Locher C, Desfourneaux V, Merdrignac A, Bergeat D, Lakehal M, Sulpice L, Houssel-Debry P, Jezequel C, Camus C, Bardou-Jacquet E, Meunier B. Hypothermic Oxygenated Perfusion Improves Extended Criteria Donor Liver Graft Function and Reduces Duration of Hospitalization Without Extra Cost: The PERPHO Study. Liver Transpl. 2021 Feb;27(3):349-362. doi: 10.1002/lt.25955.

Reference Type: DERIVED

PMID: 33237618 (View on PubMed)

Other Identifiers

2017-A00085-48

Identifier Type: OTHER

Identifier Source: secondary_id

35RC16_9792_PERPHO

Identifier Type: -

Identifier Source: org_study_id