Liver TransplantNational OLPNCT05940857
US National OCS Liver Perfusion (OLP) Registry
An observational study of Liver Transplant, run by TransMedics at 22 sites in United States.
Trial summary
This Registry is a sponsor-initiated, multi-center, observational, post-approval registry with an independent academic oversight. TransMedics has contracted with United Network for Organ Sharing (UNOS) the Federal manager of the U.S. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Transplant
- What is being tested?
- OCS Liver
- Type of treatment
- Medical device
- How many people
- 100,000 participants
- Where
- 22 sitesUnited States
- Study dates
- 14 Oct 2021to Oct 2031
- How long will I take part?
- 5 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All liver transplant recipients who are transplanted with an OCS-perfused donor liver will be enrolled in the Registry. Patients' clinical outcomes will be followed until the later of 5 years post-transplant, loss to follow-up or death.
All liver transplant recipients.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kausar Qidwai contact
22 sites in 1 country
United States22 sites, 22 recruiting
- Recruiting
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Nicholas Demchuk
Seth Waits, MD
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Jeryl Huckaby
Denise Jennifer Lo, MD
- Recruiting
University of Alabama
Birmingham, Alabama, 35294
Leigh McManus
Robert Cannon, MD
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Madelyn Subocz
David D. Lee, MD
- Recruiting
Lahey Clinic Medical Center
Burlington, Massachusetts, 01805
Kirsten Peterson
Mohamed E. Akoad, MD
- Recruiting
Carolinas Medical Center/Atrium Health
Charlotte, North Carolina, 28203
Katheryn Peterson
Dionisios Vrochides, MD, PhD
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Morgan Marsh
David Wojciechowski, DO
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Matthew Callaghan
Iman Francis
- Recruiting
Duke Medical Center
Durham, North Carolina, 27710
Jerry Turner
Debra Sudan, MD
- Recruiting
Houston Methodist
Houston, Texas, 77030
Deborah Pokrass
Mark Hobeika, MD
- Recruiting
Mayo Clinic Hospital Florida
Jacksonville, Florida, 32224
Jessica Toukmehji
Shennen Mao, MD
- Recruiting
University of California San Diego
La Jolla, California, 92037
Denya Arellano
Gabriel Schnickel, MD, MPH
- Recruiting
University of Kentucky Medical Center
Lexington, Kentucky, 40536
Deepa Valvi
Malay B Shah
- Recruiting
NY Presbyterian Hospital/Columbia Univ. Medical Center
New York, New York, 10032
Rachel Nuccitelli
Tomoaki Kato, MD
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Michelle Leahy
Shaheed Merani, MD, PhD
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Willa Meyer
Ashesh Shah, MD
- Recruiting
Mayo Clinic Hospital Arizona
Phoenix, Arizona, 85054
Dakota Hohenwalter
Amit K. Mathur, MD
- Recruiting
Mayo Clinic Hospital Minnesota
Rochester, Minnesota, 55905
Candy Peterman
Julie K. Heimbach, MD
- Recruiting
University of Utah Medical Center
Salt Lake City, Utah, 84112
Chinedu Nwaduru, MD
Motaz Selim, MD, PhD
- Recruiting
University Hospital, University of Texas Health Science Center
San Antonio, Texas, 78229
Jillian Woodworth
Tarunjeet S Klair, MD
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Joanne Kwan
Garrett Roll, MD
- Recruiting
SSM Health Saint Louis University Hospital
St Louis, Missouri, 63103
Craig Dedert
Henry Randall, MD
About this study
This Registry is a sponsor-initiated, multi-center, observational, post-approval registry with an independent academic oversight.
TransMedics has contracted with United Network for Organ Sharing (UNOS) the Federal manager of the U.S. national transplant outcomes registry to obtain data that is routinely collected by the Organ Procurement and Transplantation Network (OPTN) on all transplanted organs in the U.S. for both the OCS liver transplanted patients as well as patients transplanted using other preservation modalities. Additional data will be collected by participating centers using OCS Liver perfusion.
- 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
The TransMedics® Organ Care System (OCS) Liver is an FDA approved portable extracorporeal liver perfusion and monitoring system.
| Study group | Role | What they receive |
|---|---|---|
| OCS Liver Transplant Recipients | The US National OLP Registry will enroll all liver transplant recipients who are transplanted with an OCS-perfused donor liver in the Registry. Receives: Device: OCS Liver | |
| Non-OCS Liver Transplant Recipients | Patients transplanted using other preservation modalities for clinical outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Recipients' patient and graft survival rates will be the primary clinical outcomes measures for all OCS Liver transplanted recipients compared to recipients receiving liver transplants using non-OCS preservation methods (cold static storage or other perfusion devices or a combination of both). This data will be obtained directly from UNOS/OPTN database.
Measured: 5 years post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start14 Oct 2021
- Primary completionOct 2031 (estimated)
- Study completionOct 2031 (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
- 100,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- TransMedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahmed Elbetanony, MD, Study director, TransMedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940857
- Sponsor's protocol ID
- OCS-LIVER-OLP-II
- Acronym
- National OLP
- Status last verified
- Aug 2024
- First submitted
- 29 Jun 2023
- Last updated
- 16 Aug 2024
- 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 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- US National OCS Liver Perfusion (OLP) Registry
- ClinicalTrials.gov ID
- NCT05940857
- Acronym / sponsor ID
- National OLP / OCS-LIVER-OLP-II
- Conditions
- Liver Transplant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- TransMedicsIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- Oct 2031 (estimated)
- Study completion
- Oct 2031 (estimated)
- First posted
- 11 Jul 2023 (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.
This Registry is a sponsor-initiated, multi-center, observational, post-approval registry with an independent academic oversight.
TransMedics has contracted with United Network for Organ Sharing (UNOS) the Federal manager of the U.S. national transplant outcomes registry to obtain data that is routinely collected by the Organ Procurement and Transplantation Network (OPTN) on all transplanted organs in the U.S. for both the OCS liver transplanted patients as well as patients transplanted using other preservation modalities. Additional data will be collected by participating centers using OCS Liver perfusion.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCS Liver Transplant Recipients | – | Device: OCS LiverThe US National OLP Registry will enroll all liver transplant recipients who are transplanted with an OCS-perfused donor liver in the Registry. |
| Non-OCS Liver Transplant Recipients | – | –Patients transplanted using other preservation modalities for clinical outcomes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All liver transplant recipients who are transplanted with an OCS-perfused donor liver will be enrolled in the Registry. Patients' clinical outcomes will be followed until the later of 5 years post-transplant, loss to follow-up or death.
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 LiverThe TransMedics® Organ Care System (OCS) Liver is an FDA approved portable extracorporeal liver perfusion and monitoring system. | Device | OCS Liver Transplant Recipients |
Primary outcome
Survival
Time frame: 5 years post-transplant
Recipients' patient and graft survival rates will be the primary clinical outcomes measures for all OCS Liver transplanted recipients compared to recipients receiving liver transplants using non-OCS preservation methods (cold static storage or other perfusion devices or a combination of both). This data will be obtained directly from UNOS/OPTN database.
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 16 Aug 2024.
Related trials for Liver Transplant
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
Liver Transplant
RecruitingObservational study
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
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.
Kausar Qidwai contact
Ahmed Elbetanony, MD study director
TransMedics
22 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 22 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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?
Contact Kelly Jork (978-494-3918, kjork@transmedics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 5 years post-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 16 Aug 2024.