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

NeuroTherapia, Inc.

Status: Completed

Conditions: Liver Transplantation; Kidney Transplantation

Treatments: Other: No TPA Treatment; Drug: rTPA Treatment

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01197573

CCIRB: 10-365

R38OT15491 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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103 participants in 4 patient groups

Standard DCD liver transplant

Active Comparator group

Description:

Standard method of liver transplant utilizing a DCD organ

Treatment:

Other: No TPA Treatment

rTPA Treatment Liver Transplant

Active Comparator group

Description:

Ex-vivo treatment of liver donated after cardiac death (DCD) with rTPA

Treatment:

Drug: rTPA Treatment

Standard DCD kidney transplant

Active Comparator group

Description:

Standard method of kidney transplant utilizing a DCD organ

Treatment:

Other: No TPA Treatment

rTPA Treatment Kidney Transplant

Active Comparator group

Description:

Ex-vivo treatment of kidney donated after cardiac death (DCD) with rTPA

Treatment:

Drug: rTPA Treatment