Pediatric Liver TransplantationHOPE SPLITNCT07918183
Hypothermic Oxygenated Machine PErfusion During Ex-vivo SPLITting in Liver Pediatric Transplantation (HOPESPLIT)
A study testing End-ischemic Hypothermic Oxygenated Machine Perfusion (HOPE) and Classic static cold storage in people with Pediatric Liver Transplantation, run by Hospices Civils de Lyon at 7 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pediatric Liver Transplantation
- What is being tested?
- End-ischemic Hypothermic Oxygenated Machine Perfusion (HOPE) and Classic static cold storage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 7 sitesFrance
- Study dates
- Jan 2027to Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
Show all 17Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
Bron, 69500
Guillaume ROSSIGNOL, guillaume.rossignol@chu-lyon.fr
Guillaume ROSSIGNOL
APHP Hopital Beaujon
Clichy, 92210
Mickael LESURTEL, mickael.lesurtel@aphp.fr
Mickael LESURTEL
APHP Kremlin Bicetre
Le Kremlin-Bicêtre, 94270
Géraldine HERY, geraldine.hery@aphp.fr
Géraldine HERY
Hospices Civils de Lyon - Hôpital de la Croix Rousse
Lyon, 69004
Guillaume ROSSIGNOL, guillaume.rossignol@chu-lyon.fr
Guillaume Rossignol
APHP Pitié Salpétrière
Paris, 75013
Claire GOUMARD, claire.goumard@aphp.fr
Claire GOUMARD
APHP Hôpital Necker Enfants Malades
Paris, 75015
Christophe CHARDOT, christophe.chardot@aphp.fr
Christophe CHARDOT
APHP Paul Brousse
Villejuif, 94804
Marc-Antoine ALLARD, marcantoine.allard@aphp.fr
Marc-Antoine ALLARD
About this study
Official title: 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.
- Conditions
- Pediatric Liver Transplantation
- Being tested
- End-ischemic Hypothermic Oxygenated Machine Perfusion (HOPE), Classic static cold storage
- Keywords
- Liver Transplantation, Liver machine perfusion, Split Liver Transplantation, Pediatric Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End-ischemic Hypothermic Oxygenated Machine Perfusion (HOPE)Device
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).
Classic static cold storageDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| HOPE group | Experimental | Use of HOPE (End-ischemic Hypothermic Oxygenated Machine Perfusion) during ex vivo liver splitting Receives: Device: End-ischemic Hypothermic Oxygenated Machine Perfusion (HOPE) |
| Classic static cold storage group | Active comparator | Standard splitting technique performed during static cold storage Receives: Device: Classic static cold storage |
What is being measured
The primary outcome is the main question the study is designed to answer.
liver graft-related morbidity
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2031 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918183
- Sponsor's protocol ID
- 69HCL22_0861
- Other IDs
- 2025-A02005-44
- Acronym
- HOPE SPLIT
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypothermic Oxygenated Machine PErfusion During Ex-vivo SPLITting in Liver Pediatric Transplantation (HOPE SPLIT): A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07918183
- Acronym / sponsor ID
- HOPE SPLIT / 69HCL22_0861
- Conditions
- Pediatric Liver Transplantation
- Keywords
- Liver Transplantation, Liver machine perfusion, Split Liver Transplantation, Pediatric Transplantation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HOPE group | Experimental | Device: End-ischemic Hypothermic Oxygenated Machine Perfusion (HOPE)Use of HOPE (End-ischemic Hypothermic Oxygenated Machine Perfusion) during ex vivo liver splitting |
| Classic static cold storage group | Active comparator | Device: Classic static cold storageStandard splitting technique performed during static cold storage |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| End-ischemic Hypothermic Oxygenated Machine Perfusion (HOPE)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). | Device | HOPE group |
| Classic static cold storageThe 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. | Device | Classic static cold storage group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing End-ischemic Hypothermic Oxygenated Machine Perfusion (HOPE) and Classic static cold storage in people with Pediatric Liver Transplantation, run by Hospices Civils de Lyon at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume ROSSIGNOL (+33427856015, guillaume.rossignol@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
liver graft-related morbidity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.