Trial Outcomes & Findings for OCS Liver DCD Trial (NCT NCT04194437)
NCT ID: NCT04194437
Last Updated: 2025-09-05
Results Overview
Evaluation of graft survival as defined per UNOS data collection criteria for graft status after liver transplantation
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
6 months
Results posted on
2025-09-05
Participant Flow
Participant milestones
| Measure |
OCS Preserved Livers
OCS Liver System: OCS Liver System for preserving and assessing donor livers for transplantation from DCD donors.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
OCS Liver DCD Trial
Baseline characteristics by cohort
| Measure |
OCS Preserved Livers
n=9 Participants
OCS Liver System: OCS Liver System for preserving and assessing donor livers for transplantation from DCD donors.
|
|---|---|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 13.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsEvaluation of graft survival as defined per UNOS data collection criteria for graft status after liver transplantation
Outcome measures
| Measure |
OCS Preserved Livers
n=9 Participants
OCS Liver System: OCS Liver System for preserving and assessing donor livers for transplantation from DCD donors.
|
|---|---|
|
Liver Graft Survival Through 6 Months Post-transplant
|
8 Participants
|
Adverse Events
OCS Preserved Livers
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OCS Preserved Livers
n=9 participants at risk
OCS Liver System: OCS Liver System for preserving and assessing donor livers for transplantation from DCD donors.
|
|---|---|
|
Gastrointestinal disorders
Intra-abdominal Hemorrhage
|
11.1%
1/9 • Number of events 1 • Liver graft-related serious adverse events (LGRSAEs) were collected up to the 30-day follow-up after transplantation. Ischemic biliary cholangiopathy was collected at 6 months post-transplant. Reporting of all-cause mortality is through 6-months post transplant.
Per the protocol only liver graft-related serious adverse events (LGRSAEs) and serious adverse events (SAEs) will be collected through Day 30 post-transplant. Ischemic biliary cholangiopathy was collected at 6 months post-transplant. Other (Not Including Serious) Adverse Events were not collected and therefore not reported.
|
|
Vascular disorders
Hepatic Artery Dissection
|
11.1%
1/9 • Number of events 1 • Liver graft-related serious adverse events (LGRSAEs) were collected up to the 30-day follow-up after transplantation. Ischemic biliary cholangiopathy was collected at 6 months post-transplant. Reporting of all-cause mortality is through 6-months post transplant.
Per the protocol only liver graft-related serious adverse events (LGRSAEs) and serious adverse events (SAEs) will be collected through Day 30 post-transplant. Ischemic biliary cholangiopathy was collected at 6 months post-transplant. Other (Not Including Serious) Adverse Events were not collected and therefore not reported.
|
|
Hepatobiliary disorders
Ischemic Biliary Stricture
|
11.1%
1/9 • Number of events 1 • Liver graft-related serious adverse events (LGRSAEs) were collected up to the 30-day follow-up after transplantation. Ischemic biliary cholangiopathy was collected at 6 months post-transplant. Reporting of all-cause mortality is through 6-months post transplant.
Per the protocol only liver graft-related serious adverse events (LGRSAEs) and serious adverse events (SAEs) will be collected through Day 30 post-transplant. Ischemic biliary cholangiopathy was collected at 6 months post-transplant. Other (Not Including Serious) Adverse Events were not collected and therefore not reported.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Site shall have right to publish results. To balance this right with TransMedics' (TM proprietary interests, site will submit manuscripts intended for publication for TM's review at least 30d prior to submission date. TM will complete its review within 30d of receipt. TM may request that site delete from its manuscripts any reference to TM confidential information and site shall promptly comply with such request. After 60d period, site will have right to publish manuscript, as amended by TM.
- Publication restrictions are in place
Restriction type: OTHER