None listed
Conditions
Brief summary
Liver transplantation requires the donor liver to be stored for the period of time between being removed from the donor and transplanted into a recipient. This storage period can be up to 12 hours and during this time the liver does not receive any oxygen. Even though the liver is stored on ice, the lack of oxygen can result in injury to the liver cells and impair recovery after the transplant. M101 is a recently discovered oxygen carrying molecule with properties that make it very well suited for organ preservation. M101 will be added to the preservation fluid to provide oxygen during the period of storage, in order to prevent injury to liver cells from lack of oxygen. Studies in kidney transplantation found M101 to be safe and have a beneficial effect on kidney recovery after transplantation. M101 has also shown promising results in animal models of liver transplantation. However, it has not yet been tested in human liver transplantation. We would like to test whether adding M101 to the preservation fluid during storage of the donor liver improves liver function and patient recovery after the transplant. We will also assess whether M101 improves mitochondrial function (mitochondria are inside the liver cells and convert oxygen into the energy that the cells need to function) and modifies the immune response (which is activated by cell damage due to lack of oxygen). We hope that this research will lead to ways to improve the preservation of liver grafts used for transplantation, and that this will lead to better outcomes for patients.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
Standard criteria graft from brain death deceased donor Adult recipient of first liver transplant Able to give informed consent
Exclusion criteria
Donation after circulatory death or extended criteria graft Re-transplantation Acute liver failure Split liver transplant