NCT03376074

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 19, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2019

Completed
Last Updated

March 11, 2019

Status Verified

February 1, 2019

Enrollment Period

12 months

First QC Date

December 7, 2017

Last Update Submit

March 8, 2019

Conditions

Hepatocellular Injury

Keywords

liver transplantationhypothermic machine liver perfusionextended criteria liver grafts

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Evaluation of the impact of PHO during the conservation of ECD liver grafts on intraoperative morbidity

    Day 1

  • Evaluation of the impact of PHO during the conservation of ECD liver grafts on intraoperative morbidity

    Day 1

  • Evaluation of the impact of PHO during the conservation of ECD liver grafts on postoperative morbidity

    Day 7

  • Evaluation of graft's survival

    Month 3

  • Number of days of hospitalization (initial stay) after transplantation

    Postoperative course

  • +3 more secondary outcomes

Study Arms (2)

Hypothermic oxygenated perfusion (HOPE)

EXPERIMENTAL

Application of HOPE for 2 hours

Device: Hypothermic oxygenated perfusion (HOPE)

Conventional cold storage

ACTIVE COMPARATOR
Other: Conventional cold storage

Interventions

Hypothermic oxygenated perfusion (HOPE)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

Hypothermic oxygenated perfusion (HOPE)
Conventional cold storageOTHER

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

Conventional cold storage

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Rennes

Rennes, 35033, France

Location

Related Publications (1)

  • 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.

    PMID: 33237618DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2017

First Posted

December 18, 2017

Study Start

February 19, 2018

Primary Completion

February 7, 2019

Study Completion

February 7, 2019

Last Updated

March 11, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)