Can warming and supplying oxygen to a donor liver before transplantation improve the success of liver transplants?

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2018
INTERVENTION: Randomisation: 1:1 block randomisation. The donor liver is randomised by our study design. Only patients who had given informed consent to participate in the study will be included in the randomisation and the study. Control study arm: Procedure according to usual clinical standards without any experimental treatment. Experimental study arm: Livers will be put on a CE‐certified organ perfusion machine (Liver Assist®, Fa. Organ Assist, The Netherlands) and machine perfusion started via the hepatic artery and hepatic portal vein in a closed circuit with Belzer machine perfusion solution. Perfusate will be oxygenated to a pO2 >500mmHg via two oxygenators included in the arterial and portal circuits. The temperature of the perfusate will be increased slowly over time to reach a steady state of 20°C after 60 min. Total perfusion time will be 90 min or slightly longer, if the recipient preparation time exceeds the minimum perfusion time of 90 min (for further details see: Hoyer DP et al. Controlled Oxygenated Rewarming of Cold Stored Livers Prior to Transplantation: First Clinical Application of a New Concept. Transplantation. 2016;100:147‐52). CONDITION: Preservation and transplantation of liver grafts ; Surgery ; Liver transplant PRIMARY OUTCOME: Serum peak value of aspartate aminotransferase (AST) during the first 3 days after transplantation SECONDARY OUTCOME: ; 1. Death assessed using patient medical records from admission until 3 months after transplantation; 2. Early Allograft Dysfunction (EAD) according to Olthoff (bilirubin >10 mg/dl or INR >1.6 at POD 7, or peak‐AST >2000 U/l during first week after transplantation, based on patient medical records from admission until 1 week after transplantation; 3. Re‐transplantation assessed using patient medical records from admission until 3 months after transplantation; 4. Duration of stay in intensive care unit assessed using patient medical records; 5. Ischemia reperfusion injury based on laboratory tests assessed using patient medical records from admission until 1 week after transplantation; 6. Liver maximum function capacity assessed using LiMAx® test 1 day after transplantation; 7. Evaluation of correlation of machine perfusion parameters (obtained during ex vivo machine perfusion) with ulterior graft function after transplantation as assessed using patient medical records from admission until 3 month after transplantation; All patients are observed for 7 days following transplantation on a daily basis. Follow up includes additional observations on the day of discharge and 3 months after transplantation. Patients are followed until 3 months after the last patient is randomised for this trial and are asked to attend clinical routine follow up subsequent to termination of the study.; INCLUSION CRITERIA: Inclusion criteria for the recipient: 1. Aged =18 years 2. Indication for liver transplantation 3. Listed as 'transplantable' at Eurotransplant 4. Resident in Germany 5. Provided informed consent Inclusion criteria for donor liver: 1. Expanded criteria donor 2. Donor liver offered to the Transplantation Clinic Essen 3. Requiring one of the following criteria: 3.1. Age of donor >65 years 3.2. Intensive care including ventilation of the donor for >7 days 3.3. Obesity in the donor, i.e. BMI >30 kg/m2 3.4. Serum sodium >165 Mol/l, 3.5. Aspartate aminotransferase (AST/GOT) or alanine aminotransferase (ALT/GPT) >3 x normal 3.6. Serum bilirubin >3 mg/dl (last value prio
Epistemonikos ID: 912629fa4eab075ab1b1cf457d5a754d5134885d
First added on: Aug 24, 2024