Liver Transplant
Conditions
Brief summary
Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.
Detailed description
A prospective, single arm, continued access protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers having one or more of the following characteristics: 1. Donor age equal to or greater than 40 years old, or 2. Expected cross clamp time of 6 hours or greater, or 3. Donor after circulatory death (DCD) with age less than or equal to 55 years; or 4. Steatotic lever \>0% and less than or equal to 40% at time of retrieval, based on pre-retrieval histology) A maximum of 21 sites will enroll up to 184 transplanted liver recipients. The primary effectiveness endpoint will be the incidence of Early Allograft Dysfunction (EAD) or primary non-function. All recipients will be followed for 24 months from the date of transplantation (some of which will be post-market).
Interventions
DEVICEOCS Liver System
OCS Liver System for preserving and assessing donor livers for transplantation
Sponsors
TransMedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, single-arm, continued access protocol
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Recipient Inclusion Criteria: * Registered primary liver transplant candidate, male or female * Age ≥ 18 years * Signed (1) written informed consent document and (2) authorization to use and disclose protected health information
Exclusion criteria
* Acute, fulminant liver failure * Prior solid organ or bone marrow transplant * Chronic use of hemodialysis or diagnosis of chronic renal failure, defined as chronic serum creatinine of \> 3 mg/dl for \> 2 weeks and/or requiring hemodialysis * Multi-organ transplant * Ventilator dependent * Dependent on \> 1 IV inotrope to maintain hemodynamics Donor Inclusion Criteria * Donor age ≥ 40 years, or * Expected cross-clamp time ≥ 6 hours, or * Donor after circulatory death (DCD) with age ≤ 55 years, or * Steatotic liver \> 0% and ≤ 40% macrosteatosis at time of retrieval Donor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Early Liver Allograft Dysfunction (EAD) | 7 days | Participants with Early liver Allograft Dysfunction (EAD) or primary non-function, defined as presence of one or more of the following criteria: AST level \> 2000 IU/ml within the first 7 postoperative days; Bilirubin ≥ 10 mg/dl on postoperative day 7; INR ≥ 1.6 on postoperative day 7; or Primary non-functioning graft within the first 7 days (defined as irreversible graft dysfunction requiring emergency liver re-transplantation or death, in the absence of immunologic or surgical causes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Survival at Day 30 After Transplant | 30 days after transplant | Patient survival at day 30 post transplantation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm OCS Liver System: OCS Liver System for preserving and assessing donor livers for transplantation | 74 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Treatment Arm |
|---|---|
| Age, Continuous | 57.01 Years STANDARD_DEVIATION 11.572 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 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 | 6 Participants |
| Race (NIH/OMB) White | 62 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 74 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 4 / 74 |
Outcome results
Primary
Participants With Early Liver Allograft Dysfunction (EAD)
Participants with Early liver Allograft Dysfunction (EAD) or primary non-function, defined as presence of one or more of the following criteria: AST level \> 2000 IU/ml within the first 7 postoperative days; Bilirubin ≥ 10 mg/dl on postoperative day 7; INR ≥ 1.6 on postoperative day 7; or Primary non-functioning graft within the first 7 days (defined as irreversible graft dysfunction requiring emergency liver re-transplantation or death, in the absence of immunologic or surgical causes)
Time frame: 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Arm | Participants With Early Liver Allograft Dysfunction (EAD) | 19 Participants |
Secondary
Patient Survival at Day 30 After Transplant
Patient survival at day 30 post transplantation.
Time frame: 30 days after transplant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Arm | Patient Survival at Day 30 After Transplant | 73 Participants |