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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A00546-51 | Other Identifier | ANSM |
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Given the scarce donor supply, an increasing number of so-called marginal or extended criteria donor (ECD) organs have been used for liver transplantation. These ECD liver grafts are, however, known to be associated with a higher rate of early allograft dysfunction (EAD) and primary non-function because of a greater vulnerability to ischemia-reperfusion injury. The end-ischemic Hypothermic Oxygenated Machine Perfusion (HOPE) technique may improve outcomes of liver transplantation with ECD grafts by decreasing reperfusion injury.
The study aim is to assess the efficacy of HOPE used before transplantation of ECD liver grafts from brain-dead donors in reducing postoperative EAD within the first 7 postoperative days (POD) compared to simple cold static storage.
The study is comparative open-label, multicenter, national, prospective, randomized, in two parallel groups, using the gold standard procedure as control.
This multicentric randomized controlled trial concerns adult patients undergoing whole liver transplantation in any of the 8 participating centers in France, who will receive an ECD liver graft from a brain-dead donor.
After providing written informed consent prior to the performance of any study specific procedure, the recruited patients will be randomized either in the experimental group (HOPE group) or in the control group.
In the HOPE group, ECD liver grafts will undergo a hypothermic oxygenated perfusion (HOPE) via the portal vein for a period of 1 to 4 hours (minimum 1 hour) after the "back-table" phase (graft preparation), in parallel with the recipient hepatectomy, using the CE-certified Liver Assist® perfusion pump/device (Organ Assist®, the Netherlands) with Machine Perfusion Solution (Belzer-MPS, CE-certified).
The control group will consist of a classic static cold (4°C) storage with Institute George Lopez (IGL-1)® solution from graft harvesting until liver transplantation, which is the gold standard procedure in liver transplantation.
The primary endpoint will be early allograft dysfunction (EAD) according to Olthoff's criteria, which will be compared with the Model of Early Allograft Function score (MEAF score) and the Liver Graft Assessment Following Transplantation risk factor (L-GrAFT).
According to the primary endpoint, a sample size of 133 patients per randomized group (266 in total) is needed. The duration of the inclusion period is expected to be 36 months with a 1-year follow-up for each patient.
The potential impacts of the study are expected on 3 levels: (1) for the patient, decreased postoperative morbidity and mortality of liver transplantation with ECD donors; (2) for the French liver transplantation community, familiarization with liver machine perfusion, and (3) economically, decreased costs of liver transplantation (health economic analysis included in the study).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HOPE group | Experimental | hypothermic oxygenated perfusion |
|
| Control group | Active Comparator | classic static cold storage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| End-ischemic Hypothermic Oxygenated Machine Perfusion (HOPE) | Device | In the experimental group, ECD liver grafts will first undergo a classical static cold (4°C) storage with Institute George Lopez (IGL-1)® solution from graft harvesting until transport to the transplantation center. They will then undergo a hypothermic oxygenated perfusion (HOPE) via the portal vein for a period of 1 to 4 hours (minimum 1 hour) after the "back-table" phase (graft preparation), in parallel with the recipient hepatectomy, using the CE-certified Liver Assist® perfusion pump/device (Organ Assist®, the Netherlands) with Machine Perfusion Solution (Belzer-MPS, CE-certified). |
| Measure | Description | Time Frame |
|---|---|---|
| Early allograft dysfunction (EAD) according to Olthoff criteria. | EAD is defined by the presence of at least one of the following criteria:
| During the first postoperative week |
| Measure | Description | Time Frame |
|---|---|---|
| Model of Early Allograft Function score (MEAF score). | The MEAF score includes bilirubin, ALT max and INR max at postperative day 3. Range 0 (better outcome) to 10 (worse outcome) | During the first 3 postoperative days. |
| Liver Graft Assessment Following Transplantation risk factor (L-GrAFT) |
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Inclusion Criteria:
Provide written informed consent prior to the performance of any study specific procedure
Affiliated to the French social security system
Recipient age ≥ 18 years
Patients undergoing primary liver transplantation.
Candidate for a first elective liver transplantation, whatever the indication, with a liver graft harvested from a brain-dead ECD defined by the presence of at least one of the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mickael LESURTEL | APHP Beaujon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of HPB surgery and liver transplantation Beaujon University Hospital | Clichy | 92210 | France | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37280696 | Background | Pradat P, Pantel S, Maynard M, Lalande L, Thevenon S, Adam R, Allard MA, Robin F, Rayar M, Boleslawski E, Scatton O, Chirica M, Faitot F, Bachellier P, Soubrane O, Mohkam K, Mabrut JY, Lesurtel M. End-ischemic hypothermic oxygenated perfusion for extended criteria donors in liver transplantation: a multicenter, randomized controlled trial-HOPExt. Trials. 2023 Jun 6;24(1):379. doi: 10.1186/s13063-023-07402-0. | |
| 41110608 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 13, 2026 | |
| Reset | Mar 4, 2026 | |
| Release | Mar 31, 2026 |
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|
| classic static cold storage | Device | The control group will consist of a classic static cold (4°C) storage with Institute George Lopez (IGL-1)® solution from graft harvesting until liver transplantation, which is the gold standard procedure in liver transplantation |
|
L-GrAFT includes aspartate aminotransferase (AST), INR, total bilirubin and platelets every day until postoperative day 10. Range -6 (better outcome) to +6 (worse outcome) |
| During the first 10 postoperative days. |
| Untargeted liver graft metabolic profiling | Untargeted liver graft metabolic profiling (by High-Resolution Nuclear Magnetic Resonance - 1H HR-Nuclear Magnetic Resonance (NMR) Spectrometer) on liver graft biopsies on the back-table before and after liver machine perfusion. | Day of liver transplantation (Day 0) |
| Occurrence of post-reperfusion syndrome | Defined as a 50% decrease in median arterial pressure during the 5 minutes following the graft revascularization | Day of liver transplantation (Day 0) |
| 90-day morbidity and mortality | Severe postoperative complications (Dindo-Clavien ≥3) / death | During the first 90 days after surgery. |
| Length of intermediate care unit stay (days) | Duration of intermediate care unit stay | From randomization until intermediate care unit discharge, estimated up to 7 days |
| Length of hospital stay (days) | Duration of hospital stay | From randomization until hospital discharge, estimated up to 21 days |
| Liver contrast-enhanced MRI including a Magnetic Resonance CholangioPancreatography (MRCP) | Assessment of intra- and extrahepatic biliary complications (except for patients who underwent a re-transplanted during the study). | Within 1 year after liver transplantation |
| 3-month and one-year patient and graft survivals | Actuarial graft and patient's survival rates | within one year after liver transplantation |
| Hospital costs (Euros) of liver transplantation | Hospital costs of liver transplantation | At one year after liver transplantation |
| CHU Grenoble Alpes - Department of HPB surgery and liver transplantation |
| Grenoble |
| 38000 |
| France |
| Department of HPB surgery and liver transplantation Claude Huriez University Hospital | Lille | 59037 | France |
| Hospices Civils de Lyon | Lyon | 69004 | France |
| APHP - Pitié Salpétrière | Paris | 75013 | France |
| Department of HPB surgery and liver transplantation Pontchaillou University Hospital | Rennes | 35033 | France |
| Hôpital Hautepierre - Department of HPB surgery and liver transplantation | Strasbourg | 67200 | France |
| Department of HPB surgery and liver transplantation Paul Brousse University Hospital | Villejuif | 94804 | France |
| Result |
| Lesurtel M, Mohkam K, Allard MA, Adam R, Robin F, Rayar M, Boudjema K, Chebaro A, Boleslawski E, Savier E, Scatton O, Girard E, Chirica M, Dokmak S, Soubrane O, Faitot F, Bachellier P, Hervieu V, Guerre P, Atfeh J, Pantel S, Thevenon S, Maynard M, Pradat P, Mabrut JY. A French multicenter randomized controlled trial of hypothermic oxygenated perfusion in extended criteria donor liver transplantation. Am J Transplant. 2026 Mar;26(3):607-620. doi: 10.1016/j.ajt.2025.10.006. Epub 2025 Oct 17. |
| Reset | Apr 20, 2026 |
| Release | Jun 11, 2026 |
| Reset | Jul 9, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 13, 2026 | Mar 4, 2026 | |||
| Mar 31, 2026 | Apr 20, 2026 | |||
| Jun 11, 2026 | Jul 9, 2026 |