Clinical trial · Interventional
Dual Hypothermic Oxygenated Machine Perfusion in Liver Transplantation Using Allografts From Donors After Brain Death
Improving Quality of Livers Procured for Transplantation From Deceased Donors Using Hypothermic Machine Perfusion
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This will be a randomized study on the effects of hypothermic oxygenated machine perfusion in patients undergoing liver transplantations from donors after brain death with allocation of patients to either end-ischemic hypothermic oxygenated machine perfusion group (at least 2 hours of allograft perfusion at 12 degrees Celsius though hepatic artery and portal vein prior to implantation) or simple cold storage group in a 1:3 ratio. The primary outcome measure of the study will be model for early graft dysfunction (MEAF) score. A total number of 104 patients, including 26 in the hypothermic perfusion group and 78 in simple cold storage group will be included. Data on potential risk factors for worse allograft function and increased ischemia-reperfusion injury will be collected perioperatively. Circulating levels of proinflammatory cytokines (IL-2, IL-10, TNFα), nuclear damage (HMGB-1, 8-OHdG), serum activity of transaminases, gamma-glutamyl-transpeptidase, bilirubin concentration, and INR will be assessed in the perioperative period. Wedge allograft biopsies will be performed 90 minutes post-reperfusion to evaluate activation of innate immunity (TLR4), activation of endothelium (vWF, P-selectin), hepatocyte necrosis, hepatocyte apoptosis (TUNEL assay), ATP content, and oxidative damage (malondialdehyde content). Further, wedge biopsies will be performed at the end of simple cold storage and at the beginning and after two hours of perfusion to determine steatosis and ATP content. During the perfusion, perfusate samples will be periodically tested for lactate, sodium, and potassium concentration, CO2 partiall pressure, and flavin mononucleotide concentration. Patients will be closely monitored in the postoperative period for allograft function and secondary end-points: 2-year recipient and graft survival, 2-year incidence of biliary complications, and 90-day complication rate. Both groups will be compared with respect to the primary and secondary end-points, circulating levels of IL-2, IL-10, TNFα, HMGB-1, 8-OHdG, activity of transaminases and gamma-glutamyl-transpeptidase, and findings in post-reperfusion allograft biopsies. Further, changes of hepatic steatosis and hepatic ATP content during perfusion will be evaluated, and the results of perfusate analyses will be tested as predictors of allograft function in the post-transplant period.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cirrhosis | — | UNRESOLVED | — |
| Liver Transplant Failure and Rejection | — | UNRESOLVED | — |
| Liver Tumor | Liver Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypothermic oxygenated machine perfusion | Procedure | — | UNRESOLVED |
| Simple cold storage | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hypothermic oxygenated machine perfusion
- description
- Allografts will be subject to end-ischemic hypothermic oxygenated perfusion at 12 degrees Celsius through both hepatic artery and portal vein after a period of simple cold storage at 4 degrees Celsius and immediately prior to implantation. The perfusion will last at least 2 hours and the period will be prolonged in case of ongoing hepatectomy, in order to perform graft implantation immediately after perfusion.
- interventionNames
- Procedure: Hypothermic oxygenated machine perfusion
- type
- ACTIVE_COMPARATOR
- label
- Simple cold storage
- description
- Allografts will be stored in perfusate at 4 degrees Celsius from the procurement until implantation.
- interventionNames
- Procedure: Simple cold storage
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age \>18 years * deceased-donor liver transplantation * provision of informed consent Exclusion Criteria: * donation after cardiac death * either reduced or split graft
References
Publications (1)
- DERIVEDGrat M, Morawski M, Zhylko A, Rykowski P, Krasnodebski M, Wyporski A, Borkowski J, Lewandowski Z, Kobryn K, Stankiewicz R, Stypulkowski J, Holowko W, Patkowski W, Mielczarek-Puta M, Struga M, Szczepankiewicz B, Gornicka B, Krawczyk M. Routine End-ischemic Hypothermic Oxygenated Machine Perfusion in Liver Transplantation From Donors After Brain Death: A Randomized Controlled Trial. Ann Surg. 2023 Nov 1;278(5):662-668. doi: 10.1097/SLA.0000000000006055. Epub 2023 Jul 27. PMID 37497636