NCT01197573

Enhancing Donated After Cardiac Death (DCD) Utilization With Thrombolytic Therapy

Enhancing DCD Utilization With Thrombolytic Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Transplantation
• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	rTPA Treatment	Ex-vivo treatment of DCD liver or kidney with rTPA (recombinant tissue plasminogen activator)prior to implantation
OTHER	No TPA Treatment	Standard of Care

Timeline

• Start date: 2010-04-01
• Primary completion: 2015-10-01
• Completion: 2018-05-01
• First posted: 2010-09-09
• Last updated: 2018-08-28
• Results posted: 2018-08-28

Locations

2 sites across 1 country: United States