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

Enhancing DCD Utilization With Thrombolytic Therapy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01197573
Enrollment
103
Registered
2010-09-09
Start date
2010-04-30
Completion date
2018-05-31
Last updated
2018-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation, Liver Transplantation

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.

Interventions

DRUGrTPA Treatment

Ex-vivo treatment of DCD liver or kidney with rTPA (recombinant tissue plasminogen activator)prior to implantation

OTHERNo TPA Treatment

Standard of Care

Sponsors

Health Resources and Services Administration (HRSA)
CollaboratorFED
The Cleveland Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Delayed Kidney Graft Function3 months
Number of Participants With Primary Liver Graft Nonfunction1 month

Secondary

MeasureTime frame
Number of Participants With Liver Ischemic-Type Biliary Strictures1 year

Countries

United States

Participant flow

Recruitment details

DCD donors from 2010 to 2013.

Participants by arm

ArmCount
Standard DCD Liver Transplant
Standard method of liver transplant utilizing a DCD organ
33
rTPA Treatment - Liver
Ex-vivo treatment of liver donated after cardiac death (DCD)with rTPA rTPA Treatment: Ex-vivo treatment of DCD liver with rTPA (recombinant tissue plasminogen activator)prior to implantation
46
rTPA Treatment - Kidney
Ex-vivo treatment of kidney donated after cardiac death (DCD)with rTPA rTPA Treatment: Ex-vivo treatment of DCD kidney with rTPA (recombinant tissue plasminogen activator)prior to implantation
12
Standard DCD Kidney Transplant
Standard method of kidney transplant utilizing a DCD organ
12
Total103

Baseline characteristics

CharacteristicStandard DCD Liver TransplantrTPA Treatment - LiverrTPA Treatment - KidneyStandard DCD Kidney TransplantTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants1 Participants1 Participants2 Participants
Age, Categorical
Between 18 and 65 years
33 Participants46 Participants11 Participants11 Participants101 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
3 Participants2 Participants8 Participants5 Participants18 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
30 Participants43 Participants4 Participants7 Participants84 Participants
Region of Enrollment
United States
33 Participants46 Participants12 Participants12 Participants103 Participants
Sex: Female, Male
Female
19 Participants15 Participants4 Participants2 Participants40 Participants
Sex: Female, Male
Male
14 Participants31 Participants8 Participants10 Participants63 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
6 / 3312 / 460 / 120 / 12
other
Total, other adverse events
12 / 338 / 465 / 127 / 12
serious
Total, serious adverse events
3 / 332 / 462 / 122 / 12

Outcome results

Primary

Delayed Kidney Graft Function

Time frame: 3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
rTPA Treatment - KidneyDelayed Kidney Graft Function5 Participants
Standard DCD Kidney TransplantDelayed Kidney Graft Function7 Participants
Primary

Number of Participants With Primary Liver Graft Nonfunction

Time frame: 1 month

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
rTPA Treatment - KidneyNumber of Participants With Primary Liver Graft Nonfunction2 Participants
Standard DCD Kidney TransplantNumber of Participants With Primary Liver Graft Nonfunction1 Participants
Secondary

Number of Participants With Liver Ischemic-Type Biliary Strictures

Time frame: 1 year

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
rTPA Treatment - KidneyNumber of Participants With Liver Ischemic-Type Biliary Strictures0 Participants
Standard DCD Kidney TransplantNumber of Participants With Liver Ischemic-Type Biliary Strictures3 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026