Hypothermic Oxygenated Machine PErfusion During Ex-vivo SPLITting in Liver Pediatric Transplantation (HOPESPLIT) (HOPE SPLIT)
Hypothermic Oxygenated Machine PErfusion During Ex-vivo SPLITting in Liver Pediatric Transplantation (HOPE SPLIT): A Multicenter Randomized Controlled Trial
Ex-vivo split liver transplantation (SLT) has been developed to increase organ availability and offer a rapid access to transplantation for pediatric recipients. Given the fact that in-situ liver graft splitting is both technically and logistically very challenging, ex-vivo liver graft splitting is the most frequently performed procedure in SLT in France. Due to technical aspects inherent to the ex-vivo split, these partial grafts have prolonged static cold storage time, which negatively impacts graft survival despite the use of optimal donors. Hypothermic Oxygenated Perfusion (HOPE) of whole liver grafts prior to transplantation has been shown to optimize preservation by reducing static cold storage and consequently mitigating ischemia-reperfusion injury with a positive impact on post-LT outcomes. HOPE may thereby also benefit partial liver grafts from ex-vivo splits and improve outcomes in both pediatric and adult recipients.
Several trials assessing various modalities of liver machine perfusion have been conducted, but none have included partial grafts. Moreover, although the feasibility and safety of liver graft splitting during HOPE have been demonstrated in recent publications and by our group, robust data on its impact on split liver transplantation (SLT) outcomes are still lacking.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Guillaume ROSSIGNOL
- Phone Number: +33427856015
- Email: guillaume.rossignol@chu-lyon.fr
Study Locations
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Bron, France, 69500
- Hospices Civils de Lyon - Hôpital Femme Mère Enfant
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Contact:
- Guillaume ROSSIGNOL
- Email: guillaume.rossignol@chu-lyon.fr
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Principal Investigator:
- Guillaume ROSSIGNOL
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Clichy, France, 92210
- APHP Hopital Beaujon
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Principal Investigator:
- Mickael LESURTEL
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Contact:
- Mickael LESURTEL
- Email: mickael.lesurtel@aphp.fr
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Le Kremlin-Bicêtre, France, 94270
- APHP Kremlin Bicetre
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Contact:
- Géraldine HERY
- Email: geraldine.hery@aphp.fr
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Principal Investigator:
- Géraldine HERY
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Lyon, France, 69004
- Hospices Civils de Lyon - Hôpital de la Croix Rousse
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Contact:
- Guillaume ROSSIGNOL
- Email: guillaume.rossignol@chu-lyon.fr
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Principal Investigator:
- Guillaume Rossignol
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Paris, France, 75013
- APHP Pitié Salpétrière
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Contact:
- Claire GOUMARD
- Email: claire.goumard@aphp.fr
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Principal Investigator:
- Claire GOUMARD
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Paris, France, 75015
- APHP Hôpital Necker Enfants Malades
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Contact:
- Christophe CHARDOT
- Email: christophe.chardot@aphp.fr
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Principal Investigator:
- Christophe CHARDOT
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Villejuif, France, 94804
- APHP Paul Brousse
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Contact:
- Marc-Antoine ALLARD
- Email: marcantoine.allard@aphp.fr
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Principal Investigator:
- Marc-Antoine ALLARD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Legal representatives of pediatric patients provide written informed consent prior to the performance of any study-specific procedure;
- Provide written informed consent of the adult recipient prior to the performance of any study-specific procedure;
- Donor liver graft procured from a brain-dead donor suitable for split liver transplantation and within the center specific selection criteria (Age, Weight, Body Mass Index, duration of Intensive Care Unit, Transaminases, vasopressive drugs, cardiac arrest, natremia);
- Hope split procedure performed ex situ by one of the participating center;
- Liver transplantation performed in the pediatric recipient by one of the participating centers.
Non inclusion Criteria:
- Splitting procedure performed in-situ
- Multi-organ transplantation (Liver-Kidney; Liver-Lung…)
- Grafts donated after circulatory arrest (DCD-Maastricht III)
- Patient participating in other interventional research, excluding routine care research (old regulation) and category 2 research not interfering with primary endpoint analysis
- Patients deprived of liberty by a judicial or administrative decision
- Persons under psychiatric care
- Persons admitted to a health or social institution for purposes other than research
- Adults subject to a legal protection measure (guardianship, curatorship)
- Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
- Women of childbearing potential without access to contraception considered as highly effective
- Pregnant women, or women who are breastfeeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: HOPE group
Use of HOPE (End-ischemic Hypothermic Oxygenated Machine Perfusion) during ex vivo liver splitting |
In the experimental group, liver grafts will first undergo static cold (4°C) storage with preservation solution IGL-1 from graft procurement until arrival in the transplant center. Back table preparation of the liver graft followed by liver graft splitting will be performed during hypothermic oxygenated perfusion (HOPE) via the portal vein for a period of minimum 1 hour. In the HOPE-Split group, grafts will be preserved in Belzer-MPS solution maintained between 8 and 10°C during perfusion. Of note, both the right and left liver will be perfused until the respective recipient hepatectomies are completed. HOPE perfusion will be performed using the CE-certified VitaSmartTM Machine Perfusion System (Bridge to Life (Europe) Ltd, London) with Belzer UW Machine Perfusion Solution (MPS). |
|
Active Comparator: Classic static cold storage group
Standard splitting technique performed during static cold storage |
The control group will consist of a standard static cold storage (4°C) with preservation solution IGL-1 from graft procurement until liver implantation which is the actual gold standard procedure in liver transplantation. Back table preparation and splitting procedure will both be performed in IGL-1. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
liver graft-related morbidity
Time Frame: 1 year
|
The primary endpoint is cumulative liver graft-related morbidity at 1 year after pediatric transplantation. The primary outcome measure will be the Comprehensive Complication Index which will be calculated as the total of all individual liver-related complications graded by the Clavien-Dindo score. |
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 69HCL22_0861
- 2025-A02005-44 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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