Trial Outcomes & Findings for Enhancing Donated After Cardiac Death (DCD) Utilization With Thrombolytic Therapy (NCT NCT01197573)
NCT ID: NCT01197573
Last Updated: 2018-08-28
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
103 participants
Primary outcome timeframe
3 months
Results posted on
2018-08-28
Participant Flow
DCD donors from 2010 to 2013.
Participant milestones
| Measure |
Standard DCD Liver Transplant
Standard method of liver transplant utilizing a DCD organ
|
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
|
Standard DCD Kidney Transplant
Standard method of kidney transplant utilizing a DCD organ
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
33
|
46
|
12
|
12
|
|
Overall Study
COMPLETED
|
33
|
46
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Enhancing Donated After Cardiac Death (DCD) Utilization With Thrombolytic Therapy
Baseline characteristics by cohort
| Measure |
Standard DCD Liver Transplant
n=33 Participants
Standard method of liver transplant utilizing a DCD organ
|
rTPA Treatment - Liver
n=46 Participants
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
|
rTPA Treatment - Kidney
n=12 Participants
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
|
Standard DCD Kidney Transplant
n=12 Participants
Standard method of kidney transplant utilizing a DCD organ
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
101 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
40 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
63 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
18 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
84 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
33 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
103 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 3 monthsOutcome measures
| Measure |
rTPA Treatment - Kidney
n=12 Participants
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
|
Standard DCD Kidney Transplant
n=12 Participants
Standard method of kidney transplant utilizing a DCD organ
|
|---|---|---|
|
Delayed Kidney Graft Function
|
5 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 1 monthOutcome measures
| Measure |
rTPA Treatment - Kidney
n=33 Participants
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
|
Standard DCD Kidney Transplant
n=46 Participants
Standard method of kidney transplant utilizing a DCD organ
|
|---|---|---|
|
Number of Participants With Primary Liver Graft Nonfunction
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
rTPA Treatment - Kidney
n=33 Participants
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
|
Standard DCD Kidney Transplant
n=46 Participants
Standard method of kidney transplant utilizing a DCD organ
|
|---|---|---|
|
Number of Participants With Liver Ischemic-Type Biliary Strictures
|
0 Participants
|
3 Participants
|
Adverse Events
Standard DCD Liver Transplant
Serious events: 3 serious events
Other events: 12 other events
Deaths: 6 deaths
rTPA Treatment - Liver
Serious events: 2 serious events
Other events: 8 other events
Deaths: 12 deaths
rTPA Treatment - Kidney
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Standard DCD Kidneytransplant
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard DCD Liver Transplant
n=33 participants at risk
Standard method of liver transplant utilizing a DCD organ
|
rTPA Treatment - Liver
n=46 participants at risk
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
|
rTPA Treatment - Kidney
n=12 participants at risk
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
|
Standard DCD Kidneytransplant
n=12 participants at risk
Standard method of kidney transplant utilizing a DCD organ
|
|---|---|---|---|---|
|
Surgical and medical procedures
Primary non -function
|
9.1%
3/33 • Number of events 3 • One Year
|
4.3%
2/46 • Number of events 2 • One Year
|
0.00%
0/12 • One Year
|
0.00%
0/12 • One Year
|
|
Surgical and medical procedures
Necrosis
|
0.00%
0/33 • One Year
|
0.00%
0/46 • One Year
|
0.00%
0/12 • One Year
|
8.3%
1/12 • Number of events 1 • One Year
|
|
Surgical and medical procedures
Bleeding
|
0.00%
0/33 • One Year
|
0.00%
0/46 • One Year
|
8.3%
1/12 • Number of events 1 • One Year
|
0.00%
0/12 • One Year
|
|
Surgical and medical procedures
Urinary Leak
|
0.00%
0/33 • One Year
|
0.00%
0/46 • One Year
|
8.3%
1/12 • Number of events 1 • One Year
|
8.3%
1/12 • Number of events 1 • One Year
|
Other adverse events
| Measure |
Standard DCD Liver Transplant
n=33 participants at risk
Standard method of liver transplant utilizing a DCD organ
|
rTPA Treatment - Liver
n=46 participants at risk
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
|
rTPA Treatment - Kidney
n=12 participants at risk
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
|
Standard DCD Kidneytransplant
n=12 participants at risk
Standard method of kidney transplant utilizing a DCD organ
|
|---|---|---|---|---|
|
Surgical and medical procedures
Delayed Graft Function
|
36.4%
12/33 • Number of events 12 • One Year
|
17.4%
8/46 • Number of events 8 • One Year
|
41.7%
5/12 • Number of events 5 • One Year
|
58.3%
7/12 • Number of events 7 • One Year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place