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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P200035 / PAS003 |
| Date Original Protocol Accepted |
12/09/2021
|
| Date Current Protocol Accepted |
10/27/2023
|
| Study Name |
New Enrollment PAS
|
| Device Name |
OrganOx metra System
|
| Clinical Trial Number(s) |
NCT02775162
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adolescent: 13-18 yrs,
Transit.Adolescent A (distinctively):18 yrs<22 yrs,
Transit.Adolescent B(as adults): 18 yrs < 22 yrs,
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
This is a multi-site, single arm, unblinded post-approval study comparing prospective recipients of PAS NMP livers versus historical IDE SCS livers with respect to adverse biliary-related events.
Primary Objective:
To compare the effect of NMP to SCS in the prevention of adverse biliary related events, as measured by biliary complications in subjects that received a liver from a DBD donor or a DCD donor age less than 40y.
Secondary Objectives:
1) To assess graft survival in new enrollment NMP livers in subjects that receive a liver from a DBD donor or a DCD donor age less than 40y. 2) To assess subject survival in new enrollment NMP livers in subjects that received a liver from a DBD donor or a DCD donor age less than 40y. 3) To compare the graft survival rate of subjects that received a liver from a DCD donor age 40y-70y to the graft survival rate of subjects that received a liver from a DCD donor age less than 40y.
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| Study Population |
Deceased DBD and DBD donor livers and adult liver transplant recipients more than 40y.
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| Sample Size |
315 transplanted livers, with minimum 40 livers from DCD donors less than 40y and a maximum of 105 livers from DCD donors 40y-70y.
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| Key Study Endpoints |
Primary Effectiveness Endpoint:
Adverse biliary-related events as measured by biliary complications at 3-months, 6-months, and 12-months post-transplant.
Secondary Effectiveness Endpoints
Graft survival rates, subject survival rates at 3-months, 6- months, and 12-months post-transplant
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| Follow-up Visits and Length of Follow-up |
Patients will be followed and evaluated for outcomes at 3, 6, and 12 months. Outcomes will be analyzed and reported after all available transplanted subjects have completed the 12-month post-transplant follow-up visit.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
A total of 315 liver transplant recipients were enrolled, including 210 recipients of livers from DBD donors and 105 recipients of livers from DCD donors.
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| Actual Number of Sites Enrolled |
11
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| Patient Follow-up Rate |
92.4 percent of the patients were followed to 1 year or outcome (retransplant or death). One patient was exited at 6 months by the investigator. One patient was lost to follow-up after the 6-month visit.
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| Final Safety Findings |
Results:
Primary Effectiveness Endpoint
The overall adverse biliary complication rate at 12 months in the recipients of a liver from a DBD donor or a DCD donor age less than or equal to 40 y was 22.1 percent. The non-anastomotic biliary strictures rate was 2 percent in this group.
Secondary Effectiveness Endpoints
The death censored graft survival rates at 12 months in recipients of a liver from a DBD donor or a DCD donor age less than or equal to 40 y was 97.9 percent.
The patient survival rate at 12 months in the recipients of a liver from a DBD donor or a DCD donor age less than or equal to 40 y was 94.8 percent.
The death censored graft survival rates at 6 months in recipients of a liver from a DCD donor age less than or equal to 40 y was 97.6 percent compared to 96.7 percent in recipients of a liver from a DCD donor age greater than 40 y.
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