Liver TransplantationPROTECTNCT02522871

OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation

A study testing OCS™ Liver System in people with Liver Transplantation and Liver Preservation for Transplant, run by TransMedics at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness of the OCS™ Liver to preserve and assess donor livers intended for transplantation. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Liver Transplantation, Liver Preservation for 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: 300 participants
Where: 20 sitesUnited States
Study dates: 24 Jan 2016to 5 Nov 2021
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

Registered male or female primary Liver transplant candidate
Age ≥18 years old
Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information

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

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Emory
Atlanta, Georgia, 30322
Johns Hopkins
Baltimore, Maryland, 21205
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Virginia
Charlottesville, Virginia, 22903
Ohio State University Medical Center
Columbus, Ohio, 43210
University of Texas Southwest
Dallas, Texas, 75390
Henry Ford Hospital
Detroit, Michigan, 48202
Houston Methodist
Houston, Texas, 77030
University of California San Diego
La Jolla, California, 92037
Methodist University Hospital
Memphis, Tennessee, 38104
University of Minnesota
Minneapolis, Minnesota, 55455
Mount Sinai
New York, New York, 10029
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Virginia Commonwealth University
Richmond, Virginia, 23298
University of Texas San Antonio
San Antonio, Texas, 78249
Scripps
San Diego, California, 92121
University of California San Francisco
San Francisco, California, 94143
University of Washington
Seattle, Washington, 98195
Tampa General
Tampa, Florida, 33606
Montefiore Einstein Center for Transplantation
The Bronx, New York, 10467

Other trials in United States

About this study

Official title: International Randomized Trial to Evaluate The Effectiveness of The Portable Organ Care System (OCS™) Liver For Preserving and Assessing Donor Livers for Transplantation (OCS Liver PROTECT Trial)

A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness of the OCS™ Liver to preserve and assess donor livers intended for transplantation.

Read the detailed description

The OCS™ Liver PROTECT Trial is a two-armed, multicenter, prospective, randomized, controlled pivotal trial to evaluate the effectiveness and safety of the OCS Liver to preserve and assess donor livers intended for transplantation.

Conditions: Liver Transplantation, Liver Preservation for Transplant
Being tested: OCS™ Liver System, Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OCS™ Liver SystemDevice
ControlOther

Study groups in NCT02522871
Study group	Role	What they receive
OCS Liver System	Experimental	OCS Liver System Receives: Device: OCS™ Liver System
Control	Other	Standard of care (ice) Receives: Other: Control

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
Primary Safety Endpoint: Liver Graft-related Serious Adverse Events (LGRSAEs) up to 30-days Post-transplant Per Patient
Defined as the average number of LGRSAEs (Liver Graft-Related Serious Adverse Event) up to the 30-day follow-up after transplantation per patient.
Measured: 30 days

Secondary outcomes (2)

Patient Survival at Day 30 After Transplant
Patient survival at day 30 after transplantation
Measured: 30 days after transplant
Patient Survival at Initial Hospital Discharge Post Liver Transplant
Patient survival at initial hospital discharge post liver transplantation
Measured: at initial hospital discharge post liver transplant, an average of 11 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jan 20165 Nov 2021

First posted13 Aug 2015 (estimated)
Study start24 Jan 2016
Primary completion22 Oct 2019
Study completion5 Nov 2021

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 TransplantationStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02522871
Sponsor's protocol ID: OCS-LVR-092014
Acronym: PROTECT
Status last verified: Jan 2022
First submitted: 11 Aug 2015
Last updated: 29 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Markmann JF, Abouljoud MS, Ghobrial RM, Bhati CS, Pelletier SJ, Lu AD, Ottmann S, Klair T, Eymard C, Roll GR, Magliocca J, Pruett TL, Reyes J, Black SM, Marsh CL, Schnickel G, Kinkhabwala M, Florman SS, Merani S, Demetris AJ, Kimura S, Rizzari M, Saharia A, Levy M, Agarwal A, Cigarroa FG, Eason JD, Syed S, Washburn WK, Parekh J, Moon J, Maskin A, Yeh H, Vagefi PA, MacConmara MP. Impact of Portable Normothermic Blood-Based Machine Perfusion on Outcomes of Liver Transplant: The OCS Liver PROTECT Randomized Clinical Trial. JAMA Surg. 2022 Mar 1;157(3):189-198. doi: 10.1001/jamasurg.2021.6781.
PubMed 34985503

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Liver Transplantation trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: International Randomized Trial to Evaluate The Effectiveness of The Portable Organ Care System (OCS™) Liver For Preserving and Assessing Donor Livers for Transplantation (OCS Liver PROTECT Trial)
ClinicalTrials.gov ID: NCT02522871
Acronym / sponsor ID: PROTECT / OCS-LVR-092014
Conditions: Liver Transplantation, Liver Preservation for Transplant
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: TransMedicsIndustry (pharma, biotech, devices)
Study start: 24 Jan 2016 (actual)
Primary completion: 22 Oct 2019 (actual)
Study completion: 5 Nov 2021 (actual)
First posted: 13 Aug 2015 (estimated)
Results: Posted 29 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness of the OCS™ Liver to preserve and assess donor livers intended for transplantation.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
OCS Liver System	Experimental	Device: OCS™ Liver SystemOCS Liver System
Control	Other	Other: ControlStandard of care (ice)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Registered male or female primary Liver transplant candidate
Age ≥18 years old
Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information

Key exclusion criteria (6 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 System	Device	OCS Liver System
Control	Other	Control

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)
Primary Safety Endpoint: Liver Graft-related Serious Adverse Events (LGRSAEs) up to 30-days Post-transplant Per Patient
Time frame: 30 days
Defined as the average number of LGRSAEs (Liver Graft-Related Serious Adverse Event) up to the 30-day follow-up after transplantation per patient.

2 secondary outcomes

Patient Survival at Day 30 After Transplant
Time frame: 30 days after transplant
Patient Survival at Initial Hospital Discharge Post Liver Transplant
Time frame: at initial hospital discharge post liver transplant, an average of 11 days

Results and safety

Results posted to the registry on 29 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OCS Liver System	153	142
Control	147	133

Primary outcome: Participants With Early Liver Allograft Dysfunction (EAD)

Time frame: 7 days. Count of participants. Unit: Participants

Measure	OCS Liver - Per Protocol n = 150	Control - Per-protocol n = 141	OCS Liver - mITT n = 151	Control - mITT n = 145
Value	27	44	27	47

OCS Liver - Per Protocol vs Control - Per-protocol: Difference of Proportion: -0.132, p <0.0001, one-sided Farrington and Manning
OCS Liver - mITT vs Control - mITT: Difference of Proportion: -0.145, p <0.0001, one-sided Farrington and Manning

Population analysed: 1 subject in each arm (OCS Liver and Control) has missing data and therefore the overall number of participants analyzed is different than the number reported in the Participant Flow.

Primary outcome: Primary Safety Endpoint: Liver Graft-related Serious Adverse Events (LGRSAEs) up to 30-days Post-transplant Per Patient

Time frame: 30 days. Mean (Standard Deviation). Unit: Events per patient

Measure	OCS Liver n = 153	Control n = 146
Value	0.046 (.210)	0.075 (0.265)

OCS Liver vs Control: Mean Difference (Final Values): -0.030 (95% CI -0.084 to 0.025), p <0.0001, t-test, 1 sided

Population analysed: As Treated Population

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OCS Liver System	82 of 153 (53.6%)	0 of 0	9 of 153
Control	72 of 146 (49.3%)	0 of 0	10 of 147

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34985503Markmann JF, Abouljoud MS, Ghobrial RM, Bhati CS, Pelletier SJ, Lu AD, Ottmann S, Klair T, Eymard C, Roll GR, Magliocca J, Pruett TL, Reyes J, Black SM, Marsh CL, Schnickel G, Kinkhabwala M, Florman SS, Merani S, Demetris AJ, Kimura S, Rizzari M, Saharia A, Levy M, Agarwal A, Cigarroa FG, Eason JD, Syed S, Washburn WK, Parekh J, Moon J, Maskin A, Yeh H, Vagefi PA, MacConmara MP. Impact of Portable Normothermic Blood-Based Machine Perfusion on Outcomes of Liver Transplant: The OCS Liver PROTECT Randomized Clinical Trial. JAMA Surg. 2022 Mar 1;157(3):189-198. doi: 10.1001/jamasurg.2021.6781.

Related trials for Liver Transplantation

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
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Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
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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

20 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 Transplantation and Liver Preservation for Transplant, run by TransMedics at 20 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 3 inclusion and 6 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 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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 29 Jun 2023). 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). The study lists 2 primary outcomes in all. 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 NCT02522871, 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 29 Jun 2023.