Liver TransplantNCT04186221
OCS Liver PROTECT Continued Access Protocol
A study testing OCS Liver System in people with Liver Transplant, run by TransMedics at 17 sites in United States.
Trial summary
Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers. 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 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 17 sitesUnited States
- Study dates
- 3 Feb 2020to 2 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
None listed.
Who cannot join
- 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
Show all 17Show fewer
- 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 Exclusion Criteria
- Living donors
- Liver intended for split transplants
- Positive serology (HIV, Hepatitis B surface antigen \& Hepatitis C)
- Presence of moderate or severe traumatic liver injury, or anatomical liver abnormalities that would compromise ex-vivo perfusion of the donor liver (i.e., accessory blood vessels or other anatomy that require surgical repair) and livers with active bleeding (e.g., hematomas)
- Donor livers with macrosteatosis of > 40% based on retrieval biopsy readout.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Johns Hopkins
Baltimore, Maryland, 21205
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Virginia
Charlottesville, Virginia, 22903
Ohio State University
Columbus, Ohio, 43210
University of Texas Southwest
Dallas, Texas, 75390
Henry Ford Hospital
Detroit, Michigan, 48202
Houston Methodist Hospital
Houston, Texas, 77030
Scripps
La Jolla, California, 92037
University of California San Diego
La Jolla, California, 92037
Methodist University Hospital
Memphis, Tennessee, 38104
Mount Sinai Hospital
New York, New York, 10029
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Virginia Commonwealth University Health System
Richmond, Virginia, 23298
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
UCSF
San Francisco, California, 94143
Tampa General
Tampa, Florida, 33606
Montefiore Einstein Center for Transplantation
The Bronx, New York, 10467
About this study
Official title: Continued Access Protocol To Evaluate the Effectiveness of the Portable Organ Care System (OCS) Liver for Preserving and Assessing Donor Livers for Transplantation.
Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.
Read the 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:
- Donor age equal to or greater than 40 years old, or
- Expected cross clamp time of 6 hours or greater, or
- Donor after circulatory death (DCD) with age less than or equal to 55 years; or
- 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).
- Conditions
- Liver Transplant
- Being tested
- OCS Liver System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCS Liver SystemDevice
OCS Liver System for preserving and assessing donor livers for transplantation
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Not described Receives: Device: OCS Liver System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 7 days
Secondary outcomes (1)
Patient Survival at Day 30 After Transplant
Patient survival at day 30 post transplantation.
Measured: 30 days after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start3 Feb 2020
- Primary completion2 Feb 2021
- Study completion2 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-arm, continued access protocol
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
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
- NCT04186221
- Sponsor's protocol ID
- OCS-LVR10202019
- Status last verified
- Dec 2023
- First submitted
- 26 Nov 2019
- Last updated
- 24 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Kubal C, Mihaylov P, Holden J. Oncologic indications of liver transplantation and deceased donor liver allocation in the United States. Curr Opin Organ Transplant. 2021 Apr 1;26(2):168-175. doi: 10.1097/MOT.0000000000000866.
PubMed 33650998
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continued Access Protocol To Evaluate the Effectiveness of the Portable Organ Care System (OCS) Liver for Preserving and Assessing Donor Livers for Transplantation.
- ClinicalTrials.gov ID
- NCT04186221
- Acronym / sponsor ID
- OCS-LVR10202019
- Conditions
- Liver Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- TransMedicsIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 4 Dec 2019 (actual)
- Results
- Posted 24 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Donor age equal to or greater than 40 years old, or
- Expected cross clamp time of 6 hours or greater, or
- Donor after circulatory death (DCD) with age less than or equal to 55 years; or
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-arm, continued access protocol
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: OCS Liver System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- 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
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 Liver SystemOCS Liver System for preserving and assessing donor livers for transplantation | Device | Treatment arm |
Primary outcome
Participants With Early Liver Allograft Dysfunction (EAD)
Time frame: 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)
1 secondary outcome
Patient Survival at Day 30 After Transplant
Time frame: 30 days after transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33650998Kubal C, Mihaylov P, Holden J. Oncologic indications of liver transplantation and deceased donor liver allocation in the United States. Curr Opin Organ Transplant. 2021 Apr 1;26(2):168-175. doi: 10.1097/MOT.0000000000000866.
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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.
Ahmed Elbetanony, MD study director
TransMedics
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCS Liver System in people with Liver Transplant, run by TransMedics at 17 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 0 inclusion and 17 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: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
Yes. Results are posted in the registry (first posted 24 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participants With Early Liver Allograft Dysfunction (EAD) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04186221, which also lists 1 linked publication.
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 24 Jul 2024.