Hypothermic oxygenated machine perfusion (any device)
DeviceAfter static cold storage, all grafts included in this study are subjected to >1 hour of hypothermic oxygenated machine perfusion at 4-12°C with an acellular perfusion solution.
NCT Number: NCT05520320
End-ischemic hypothermic oxygenated machine perfusion (HOPE) of human donor livers mitigates ischemia-reperfusion injury, resulting in a reduction of post-reperfusion syndrome, early allograft dysfunction and biliary complications, when compared with static cold storage. According to IDEAL-D (Idea, Development, Exploration, Assessment, Long term study-Framework for Devices), with several published randomized controlled trials on short-to-medium term outcomes, scientific evidence for HOPE has currently reached stage 3. Assessment of long-term outcomes after HOPE preservation based on real-world data (i.e., IDEAL-D stage 4) is currently still lacking. Therefore, we aim to conduct an international, multi-center, retrospective, observational cohort study to assess long-term outcomes after transplantation of donor livers preserved by hypothermic oxygenated machine perfusion (HOPE).
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Notify Me18 year and older
All sexes
Observational
University Medical Center Groningen, Groningen, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After static cold storage, all grafts included in this study are subjected to >1 hour of hypothermic oxygenated machine perfusion at 4-12°C with an acellular perfusion solution.
Time frame: Up to 5-years
Defined as time from liver transplantation until re-transplantation or death due to graft dysfunction
Time frame: Up to 5-years
Defined as time from liver transplantation until re-transplantation or all-cause death
Time frame: Up to 5-years
Defined as time from liver transplantation until all-cause death
Time frame: Up to 5-years
Defined as time from liver transplantation until occurrence of an arterial or biliary complication of Dindo-Clavien grade ≥3, dated at the time of interventional, endoscopic, or surgical treatment required to correct it (Savier E, De Rycke Y, Lim C, et al. Novel Composite Endpoint for Assessing Outcomes in Liver Transplantation: Arterial and Biliary Complication-Free Survival. Liver Transpl. 2022;28(1):75-87. doi:10.1002/lt.26269)
Time frame: Up to 5-years
Defined as a composite of:
Time frame: Up to 5-years
Defined as a composite of:
Time frame: Up to 5-years
Defined as biopsy proven Banff grade 2 or 3 rejection (Demetris AJ, Bellamy C, Hübscher SG, et al. 2016 Comprehensive Update of the Banff Working Group on Liver Allograft Pathology: Introduction of Antibody-Mediated Rejection. Am J Transplant. 2016;16(10):2816-2835. doi:10.1111/ajt.13909)
Time frame: Up to 5-years
Defined as histopathological evidence of immunologic injury with irreversible damage to the bile ducts, arteries, and veins (Demetris A, Adams D, Bellamy C, et al. Update of the International Banff Schema for Liver Allograft Rejection: working recommendations for the histopathologic staging and reporting of chronic rejection. An International Panel. Hepatology. 2000;31(3):792-799. doi:10.1002/hep.510310337)
Time frame: Up to 5-years
Defined as proportion of patients who underwent liver re-transplantation for any cause
Time frame: Up to 5-years
Defined as histological or radiologically confirmed recurrence
Time frame: Up to 5-years
Defined as renal impairment (kidney morphology, pathology, imaging, blood or urine composition abnormalities) persisting for >3 months with or without eGFR decrease, and/or eGFR <60 for >3 months with or without renal impairment (Levey AS, Eckardt K-U, Tsukamoto Y, et al. Definition and Classification of Chronic Kidney Disease: A Position Statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2005 Jun;67(6):2089-100. doi: 10.1111/j.1523-1755.2005.00365.x)
Time frame: Up to 5-years
Defined as symptoms of diabetes plus casual plasma glucose levels ≥200 mg/dL (11.1 mmol/L) or fasting plasma glucose ≥126 mg/dL (7.0 mmol/L) or 2 hours plasma glucose ≥200 mg/dL (11.1 mmol/L during an oral glucose tolerance testing (Davidson J, Wilkinson A, Dantal J, et al. New-onset diabetes after transplantation: 2003 International consensus guidelines. Proceedings of an international expert panel meeting. Barcelona, Spain, 19 February 2003. Transplantation. 2003;75(10 Suppl):SS3-24. doi:10.1097/01.TP.0000069952.49242.3E)
University Medical Center Groningen
Other
Assessment of Long-term Outcomes After Transplantation of Donor Livers Preserved by Hypothermic Oxygenated Machine Perfusion (HOPE): a Retrospective Cohort Analysis of Real-world Data (IDEAL-D Stage 4)
Acronym: HOPE-REAL
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