Liver TransplantNCT05074160
OCS Liver Perfusion (OLP) Post-Approval Registry
An observational study of Liver Transplant, run by TransMedics at 9 sites in United States.
Trial summary
The objective of the OLP Registry is to collect more data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on OCS Liver System according to the approved indication and the OCS device performance in the real-world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant
- What is being tested?
- OCS Liver
- Type of treatment
- Medical device
- How many people
- 166 participants
- Where
- 9 sitesUnited States
- Study dates
- 14 Oct 2021to Jun 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential participants in the OLP Registry will be all adult primary liver transplant candidates on the waiting list for liver transplant at a U.S. liver transplant center and who meet the eligibility criteria at the participating Registry centers.
Who may be able to join
- Adult primary liver transplant recipients of DBD or DCD donor Livers perfused on OCS Liver System
- Donor Exclusion Criteria:
- Donor livers with accessory arterial blood supply requiring back table anastomosis, major traumatic injury, or hematoma; or
- Split donor liver; or
- DCD donor liver with >30 minutes of warm ischemic time (defined as from withdrawal of life support until donor liver cold flush); or
- DCD donors age >55 years; or
Show all 16Show fewer
- DCD donor liver with macrosteatosis of >15%
- Living donors
- Donors with positive serology for HIV, Hep B and C
- Donors with macrosteatosis of ≥40%
- Recipient Exclusion Criteria:
- Fulminant liver failure; or
- Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or
- Chronic renal dialysis at time of transplant; or
- Dependency on more than 1 inotropic agent to maintain hemodynamics; or
- Ventilator dependent at time of transplant.
Who cannot join
None listed.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Emory
Atlanta, Georgia, 30322
University of Alabama
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Henry Ford Hospital
Detroit, Michigan, 48202
Duke Medical Center
Durham, North Carolina, 27710
Houston Methodist
Houston, Texas, 77030
University of California San Diego
La Jolla, California, 92037
University of Nebraska Medical Center
Omaha, Nebraska, 68198
University of California San Francisco
San Francisco, California, 94143
About this study
The objective of the OLP Registry is to collect more data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on OCS Liver System according to the approved indication and the OCS device performance in the real-world setting.
Read the detailed description
OLP Registry is a multi-center, observational post-approval registry of adult primary liver transplant recipients who are transplanted with an OCS Liver-perfused DBD or DCD donor liver according to the approved indication and that match the eligibility criteria below.
- Conditions
- Liver Transplant
- Being tested
- OCS Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCS LiverDevice
Multi-center, observational post-approval registry of adult primary liver transplant recipients who are transplanted with an OCS Liver-perfused DBD or DCD donor liver according to the approved indication and that match the eligibility criteria below.
| Study group | Role | What they receive |
|---|---|---|
| OLP Registry primary analysis population | Adult primary liver transplant recipients who are transplanted with an OCS perfused DBD or DCD donor liver according to the approved indication and matching eligibility criteria Receives: Device: OCS Liver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Survival
1-year patient survival with the originally transplanted liver (patient and graft survival) post-Liver transplant.
Measured: 1 year post-Liver transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start14 Oct 2021
- Primary completion22 Mar 2024
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- More trials run by TransMedicsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 166 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- TransMedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074160
- Sponsor's protocol ID
- OCSLIVER-01-PAS
- Status last verified
- Apr 2025
- First submitted
- 29 Sep 2021
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCS Liver Perfusion (OLP) Post-Approval Registry
- ClinicalTrials.gov ID
- NCT05074160
- Acronym / sponsor ID
- OCSLIVER-01-PAS
- Conditions
- Liver Transplant
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 166 participants (actual)
- Lead sponsor
- TransMedicsIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the OLP Registry is to collect more data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on OCS Liver System according to the approved indication and the OCS device performance in the real-world setting.
Detailed description
OLP Registry is a multi-center, observational post-approval registry of adult primary liver transplant recipients who are transplanted with an OCS Liver-perfused DBD or DCD donor liver according to the approved indication and that match the eligibility criteria below.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OLP Registry primary analysis population | – | Device: OCS LiverAdult primary liver transplant recipients who are transplanted with an OCS perfused DBD or DCD donor liver according to the approved indication and matching eligibility criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential participants in the OLP Registry will be all adult primary liver transplant candidates on the waiting list for liver transplant at a U.S. liver transplant center and who meet the eligibility criteria at the participating Registry centers.
Key inclusion criteria (16 listed)
- Adult primary liver transplant recipients of DBD or DCD donor Livers perfused on OCS Liver System
- Donor livers with accessory arterial blood supply requiring back table anastomosis, major traumatic injury, or hematoma; or
- Split donor liver; or
- DCD donor liver with >30 minutes of warm ischemic time (defined as from withdrawal of life support until donor liver cold flush); or
- DCD donors age >55 years; or
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCS LiverMulti-center, observational post-approval registry of adult primary liver transplant recipients who are transplanted with an OCS Liver-perfused DBD or DCD donor liver according to the approved indication and that match the eligibility criteria below. | Device | OLP Registry primary analysis population |
Primary outcome
Patient Survival
Time frame: 1 year post-Liver transplant
1-year patient survival with the originally transplanted liver (patient and graft survival) post-Liver transplant.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant, run by TransMedics at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Survival (time frame: 1 year post-Liver transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.