Prospective randomised multicentre trial investigating liver preservation with Histidine-Tryptophan-Ketoglutarate (HTK) by simple aortic perfusion in comparison to aortic perfusion plus ex situ arterial flushing

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2007
INTERVENTION: Aortic in situ perfusion versus aortic in situ perfusion plus arterial back‐table ex situ flushing. At the beginning of the process of abdominal dissection, a tube is placed into the abdominal aorta (or into a common iliac artery). The perfusate (HTK [Histidine‐Tryptophan‐Ketoglutarate] solution) is connected to this tube. Usually a perfusion pressure of 100 to 150 cm water column is applied which is realised by elevation of the plastic bag containing the fluid. When the liver is dissected free in order to be retrieved the perfusion is started. At least 8000 ml of solution have to be used. In the control group the approach of preservation is stopped at this point, the liver is retrieved, put into plastic bags containing preservation solution and is forwarded to the transplant centre of the respective patients to whom the graft was allocated by Eurotransplant. In the case of additional ex‐situ arterial perfusion, the liver is retrieved and placed into an ice water dish. There all branches of the hepatic artery are tied, a cannula is placed into the artery at is origin and the ex‐situ perfusion is performed. For ex‐situ perfusion, 300 ml of the perfusate at a pressure of 100 cm water column is used. After that procedure, the graft is forwarded in the identical way as for non‐ex‐situ perfused grafts. The transplantation itself is going to be performed at the discretion of the respective centre. Follow‐up will be six months. CONDITION: Liver transplantation after preservation in brain‐death organ donors ; Surgery ; Transplantation surgery PRIMARY OUTCOME: Rate of ITBL six months after transplantation. SECONDARY OUTCOME: 1. Rate of ITBL or death within six months after transplantation; 2. Parenchymal function following transplantation; 3. Documentation and analysis of adverse events; ; All secondary outcomes are measured within six months after transplantation. INCLUSION CRITERIA: For the graft: 1. Liver graft retrieved in the Central Region of the German Foundation for Organ Transplantion (Region Mitte der Deutschen Stiftung Organtransplantation [DSO]) 2. Donor 18 ‐ 80 years 3. Graft allocation to a participating centre For the recipient 1. Informed consent 2. Age 18 ‐ 80 years 3. Standard criteria for liver transplantation (e.g. liver dysfunction because of cirrhosis, carcinoma)
Epistemonikos ID: f44789420dcf58f75469ffa170d18bb4036975cb
First added on: Aug 21, 2024