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NCT07918183
Hypothermic Oxygenated Machine PErfusion During Ex-vivo SPLITting in Liver Pediatric Transplantation (HOPESPLIT)
Conditions: Pediatric Liver Transplantation
Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 200
Sponsor: Hospices Civils de Lyon
Location: Hospices Civils de Lyon - Hôpital Femme Mère Enfant Bron
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 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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07918183). StuddyBuddy aggregates publicly available trial information.