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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Guillaume ROSSIGNOL
- Telefonnummer: +33427856015
- E-post: guillaume.rossignol@chu-lyon.fr
Studiesteder
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Bron, Frankrike, 69500
- Hospices Civils de Lyon - Hôpital Femme Mère Enfant
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Ta kontakt med:
- Guillaume ROSSIGNOL
- E-post: guillaume.rossignol@chu-lyon.fr
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Hovedetterforsker:
- Guillaume ROSSIGNOL
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Clichy, Frankrike, 92210
- APHP Hopital Beaujon
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Hovedetterforsker:
- Mickael LESURTEL
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Ta kontakt med:
- Mickael LESURTEL
- E-post: mickael.lesurtel@aphp.fr
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Le Kremlin-Bicêtre, Frankrike, 94270
- APHP Kremlin Bicetre
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Ta kontakt med:
- Géraldine HERY
- E-post: geraldine.hery@aphp.fr
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Hovedetterforsker:
- Géraldine HERY
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Lyon, Frankrike, 69004
- Hospices Civils de Lyon - Hôpital de la Croix Rousse
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Ta kontakt med:
- Guillaume ROSSIGNOL
- E-post: guillaume.rossignol@chu-lyon.fr
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Hovedetterforsker:
- Guillaume Rossignol
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Paris, Frankrike, 75013
- APHP Pitié Salpétrière
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Ta kontakt med:
- Claire GOUMARD
- E-post: claire.goumard@aphp.fr
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Hovedetterforsker:
- Claire GOUMARD
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Paris, Frankrike, 75015
- APHP Hôpital Necker Enfants Malades
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Ta kontakt med:
- Christophe CHARDOT
- E-post: christophe.chardot@aphp.fr
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Hovedetterforsker:
- Christophe CHARDOT
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Villejuif, Frankrike, 94804
- APHP Paul Brousse
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Ta kontakt med:
- Marc-Antoine ALLARD
- E-post: marcantoine.allard@aphp.fr
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Hovedetterforsker:
- Marc-Antoine ALLARD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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). |
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Aktiv komparator: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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liver graft-related morbidity
Tidsramme: 1 year
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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
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 69HCL22_0861
- 2025-A02005-44 (Annen identifikator: ANSM)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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