An interventional study of End-ischemic Hypothermic Oxygenated Machine Perfusion (HOPE) and Classic static cold storage in Pediatric Liver Transplantation, sponsored by Hospices Civils de Lyon. Not yet recruiting at 7 sites in France. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Treatment
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.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Use of HOPE (End-ischemic Hypothermic Oxygenated Machine Perfusion) during ex vivo liver splitting
Device: End-ischemic Hypothermic Oxygenated Machine Perfusion (HOPE)
Standard splitting technique performed during static cold storage
Device: Classic static cold storage
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).
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.
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.
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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