|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P200031 / PAS003 |
| Date Original Protocol Accepted |
09/28/2021
|
| Date Current Protocol Accepted |
|
| Study Name |
OLP New Enrollment PAS
|
| Device Name |
Organ Care System (OCS™) Liver
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
A prospective, single-arm, multi-center, new enrollment PAS designed to evaluate the short- and long-term safety and effectiveness of the OCS Liver System for DBD and DCD donor livers preserved on OCS according to the approved indication, in real-world use. The study will include all liver transplant centers in the U.S. that will commercially use the OCS Liver System, with a minimum of 15 participating sites.
|
| Study Population |
Adult primary liver transplant recipients who are transplanted with an OCS Liver-perfused DBD or DCD donor liver according to the approved indication and eligibility criteria
|
| Sample Size |
PAS will enroll the initial 160 sequential adult primary liver transplant recipients who are transplanted with an OCS-perfused DBD or DCD donor liver according to the approved indication (primary analysis population). If the initial 160 transplant recipients does not include at least 60 DCD donor liver transplants, PAS will continue to enroll only DCD donor liver recipients until 60 DCD patients have been enrolled.
For the primary endpoint (1-year patient and graft survival), a sample size of 107 subjects provides 80% power (with a one-sided alpha of 0.05).
For the safety endpoint (6-month graft survival), a sample size of 70 subjects provides 80% power (with a one-sided alpha of 0.05).
|
| Key Study Endpoints |
Primary Endpoint: 1-year patient and graft survival post-transplant
Safety Endpoint: 6-month liver graft survival post-transplant
Other Clinical Endpoints:
Incidence of ischemic, non-anastomotic biliary complications through 1-year post-transplant
Incidence of non-ischemic, anastomotic biliary complications through 6 months post-transplant
Kaplan-Meier patient survival at 1- and 2-years
Kaplan-Meier graft survival at 6 months, 1- and 2-years
Collection of OCS Liver Related Data:
OCS Liver perfusion parameters (hepatic artery flow and pressure, portal vein flow and pressure, perfusate temperature, perfusate hematocrit, perfusate venous saturation)
OCS Liver perfusion lactate levels
OCS Liver perfusate pH values
Total bile volume at end of OCS liver perfusion
Incidence of and clinical reasons for donor liver turndown
Incidence and reasons for conversion to cold storage
Device malfunctions
Utilization rate
|
| Follow-up Visits and Length of Follow-up |
2 years
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results
1 death has occurred. The death was due to Post-Transplant Lymphoproliferative Disorder (PTLD). Also, 24 biliary complications have been reported in OLP.
No other adverse events were reported.
Effectiveness Results
Data collection is ongoing and not all parameters were not available at the time of the data cut for this report.
|
| Actual Number of Patients Enrolled |
166
|
| Actual Number of Sites Enrolled |
9
|
| Patient Follow-up Rate |
The follow up period 6 months includes 130 subjects (78%), 12 months includes 53 subjects (32%).
|
| Study Strengths & Weaknesses |
Strength and weaknesses will be evaluate at the final report.
|
