Liver Transplant
Conditions
Brief summary
Evaluate the safety and effectiveness of the OCS Liver System to preserve, optimize the condition, and assess levers from DCD donors.
Detailed description
To evaluate the safety and effectiveness of the OCS™ Liver to preserve, optimize the condition and assess livers from DCD donors that currently are seldom used for liver transplants due to limitations of cold static storage with extended warm ischemic time and older donors.
Interventions
DEVICEOCS Liver System
The OCS Liver System will be used to preserve, optimize and assess livers from DCD donors.
Sponsors
TransMedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Registered primary liver transplant candidate * Age ≥ 18 years * Obtained informed consent
Exclusion criteria
* Acute, fulminant liver failure * Prior solid organ or bone marrow transplant * Ventilator dependent on day of transplant/donor organ offer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver Graft Survival Through 6 Months Post-transplant | 6 months | Evaluation of graft survival as defined per UNOS data collection criteria for graft status after liver transplantation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OCS Preserved Livers OCS Liver System: OCS Liver System for preserving and assessing donor livers for transplantation from DCD donors. | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | OCS Preserved Livers |
|---|---|
| Age, Continuous | 60.1 years STANDARD_DEVIATION 13.84 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 3 / 9 |
Outcome results
Primary
Liver Graft Survival Through 6 Months Post-transplant
Evaluation of graft survival as defined per UNOS data collection criteria for graft status after liver transplantation
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OCS Preserved Livers | Liver Graft Survival Through 6 Months Post-transplant | 8 Participants |