Long-term Outcomes After Hypothermic Oxygenated Machine Perfusion of Donor Livers Using Real-world Data

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• Hypothermia 498

Hypothermia

498 studies on the registry are indexed under Hypothermia; 53 are open to participants now.

This study's enrollment of 1,202 is above the median of 97 across 126 observational studies indexed under Hypothermia.

Lead sponsor

University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.

Study population

Interventions

• DeviceHypothermic oxygenated machine perfusion (any device)

  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.

Primary outcomes

1. Death-censored graft survival, assessed by survival analysis methods

   Defined as time from liver transplantation until re-transplantation or death due to graft dysfunction

   Time frame: Up to 5-years

Secondary outcomes

1. Overall graft survival

   Defined as time from liver transplantation until re-transplantation or all-cause death

   Time frame: Up to 5-years

2. Overall patient survival

   Defined as time from liver transplantation until all-cause death

   Time frame: Up to 5-years

3. Arterial and biliary complication-free survival (ABCFS)

   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

4. Incidence of biliary complications

   Defined as a composite of: * Non-anastomotic biliary strictures: any irregularity or narrowing of the lumen of the intrahepatic or extrahepatic donor bile ducts, excluding the biliary anastomosis, diagnosed with the use of cholangiography in combination with clinical symptoms (e.g., jaundice or cholangitis) or an elevation of cholestatic laboratory variables, in the presence of a patent hepatic artery * Anastomotic biliary strictures: strictures occurring at the anastomosis of donor choledochal duct and recipient choledochal duct or jejunal Roux-limb * Biliary leakage: fluid with an elevated (\>3x serum) bilirubin level in the abdominal drain or intra-abdominal fluid on or after post-operative day 3 or the need for radiological intervention (i.e. interventional drainage) owing to biliary collections or re-laparotomy due to biliary peritonitis

   Time frame: Up to 5-years

5. Incidence of vascular complications

   Defined as a composite of: * Hepatic arterial thrombosis: radiologically or surgically proven thrombosis of the hepatic artery * Portal vein thrombosis: radiologically or surgically proven thrombosis of the portal vein * Venous outflow tract obstruction: radiologically or surgically proven thrombosis of the main hepatic veins or the inferior vena cava

   Time frame: Up to 5-years

6. Incidence of acute cellular rejection

   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

7. Incidence of chronic rejection

   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

8. Incidence of re-transplantation

   Defined as proportion of patients who underwent liver re-transplantation for any cause

   Time frame: Up to 5-years

9. Incidence of recurrence of primary disease (including recurrence of malignancies)

   Defined as histological or radiologically confirmed recurrence

   Time frame: Up to 5-years

10. Incidence of new-onset chronic kidney disease

    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

11. Incidence of new-onset diabetes after transplantation

    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)

    Time frame: Up to 5-years

Individual participant data

Plan to share: Undecided