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

Not Applicable

Completed

• Conditions: Liver Transplantation; Kidney Transplantation
• Interventions: Other: No TPA Treatment; Drug: rTPA Treatment

• Registration Number: NCT01197573
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-09-08
• Study First Posted: 2010-09-09
• Primary Completion: 2015-10
• Study Completion: 2018-05
• Results First Submitted: 2018-06-12
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-31
• Last Update Submitted: 2018-07-31
• Results First Posted: 2018-08-28
• Last Update Posted: 2018-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• Adults aged 18 years and older
• Subjects willing/able to provide written consent
• Subjects willing/able to comply with study requirements
• Subjects who will receive a solitary organ transplant

Exclusion Criteria

• Subjects requiring multi-organ transplants
• Women who are pregnant
• Subjects with current severe systemic infection
• Subjects with an active infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard DCD kidney transplant	No TPA Treatment	Standard method of kidney transplant utilizing a DCD organ
rTPA Treatment Liver Transplant	rTPA Treatment	Ex-vivo treatment of liver donated after cardiac death (DCD) with rTPA
Standard DCD liver transplant	No TPA Treatment	Standard method of liver transplant utilizing a DCD organ
rTPA Treatment Kidney Transplant	rTPA Treatment	Ex-vivo treatment of kidney donated after cardiac death (DCD) with rTPA

Primary Outcome Measures

Name	Time	Method
Number of Participants With Primary Liver Graft Nonfunction	1 month
Delayed Kidney Graft Function	3 months

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Liver Ischemic-Type Biliary Strictures	1 year

Trial Locations

Locations (2)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

University Hospitals / Case medical Center; 🇺🇸 Cleveland, Ohio, United States