Conditions: Liver Transplantation Kidney Transplantation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 103
Healthy volunteers: no

Brief summary:
We hypothesize that delayed graft function and ITBS events may be related to small blood clots (microthrombi) that collect in the kidneys and liver after cardiac death. Treatment of the DCD organs with a thrombolytic agent prior to implantation may reduce post-transplant morbidity and mortality, and may ultimately result in a greater number of transplantable livers and kidneys.

Detailed description:
The waiting list for kidney and liver transplantation continues to increase in the United States, and therefore the need grows for additional donor organs. Utilization of organs donated after cardiac death (DCD) could be one way to increase organ availability, however there are risks associated with poorer clinical outcomes, including delayed graft function and in livers specifically, ischemic-type biliary strictures (ITBS). We hypothesize that delayed graft function and ITBS events may be related to small blood clots (microthrombi) that collect in the kidneys and liver after cardiac death. Treatment of the DCD organs with a thrombolytic agent prior to implantation may reduce post-transplant morbidity and mortality, and may ultimately result in a greater number of transplantable livers and kidneys.

Arms:
arm 1: Standard method of liver transplant utilizing a DCD organ arm 2: Ex-vivo treatment of liver donated after cardiac death (DCD) with rTPA arm 3: Standard method of kidney transplant utilizing a DCD organ arm 4: Ex-vivo treatment of kidney donated after cardiac death (DCD) with rTPA

Interventions: intervention 1: rTPA Treatment intervention 2: No TPA Treatment
Intervention descriptions: intervention 1: Ex-vivo treatment of DCD liver or kidney with rTPA (recombinant tissue plasminogen activator)prior to implantation intervention 2: Standard of Care

Protocol document: