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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Enhancing DCD Utilization With Thrombolytic Therapy

Conditions
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Liver Transplantation, Kidney Transplantation

Intervention / Treatment
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* Drug: rTPA Treatment
* Other: No TPA Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard DCD liver transplant<br>Standard method of liver transplant utilizing a DCD organ | Other: No TPA Treatment<br>* Standard of Care<br>|
| Active Comparator: rTPA Treatment Liver Transplant<br>Ex-vivo treatment of liver donated after cardiac death (DCD) with rTPA | Drug: rTPA Treatment<br>* Ex-vivo treatment of DCD liver or kidney with rTPA (recombinant tissue plasminogen activator)prior to implantation<br>* Other names: Alteplase;|
| Active Comparator: Standard DCD kidney transplant<br>Standard method of kidney transplant utilizing a DCD organ | Other: No TPA Treatment<br>* Standard of Care<br>|
| Active Comparator: rTPA Treatment Kidney Transplant<br>Ex-vivo treatment of kidney donated after cardiac death (DCD) with rTPA | Drug: rTPA Treatment<br>* Ex-vivo treatment of DCD liver or kidney with rTPA (recombinant tissue plasminogen activator)prior to implantation<br>* Other names: Alteplase;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delayed Kidney Graft Function |  | 3 months | 
| Number of Participants With Primary Liver Graft Nonfunction |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Liver Ischemic-Type Biliary Strictures |  | 1 year |