OCS Liver Preservation for Liver Transplant

No longer recruiting at 15 trial locations

Overseen By Kausar Qidwai

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: TransMedics

Disqualifiers: Acute liver failure, Prior transplant, Ventilator dependent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: OCS liver perfusion

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method called the OCS Liver System, which maintains donated livers in good condition for transplants. The goal is to determine if this system can safely and effectively preserve livers from DCD donors (donors after cardiac death) for individuals needing a liver transplant. It is suitable for registered candidates for a liver transplant who have not had previous organ transplants. Participants cannot join if they experience sudden severe liver failure or require a ventilator on the day of the transplant. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance liver transplant outcomes.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the OCS Liver System is safe for liver preservation?

Research has shown that the OCS Liver System is generally safe for liver transplants. One study found that the main safety concern was the number of serious liver-related issues within 30 days after the transplant. However, the results were encouraging. The system underwent safety testing, including checks for electrical safety.

Additional findings suggest that the OCS Liver System improves outcomes after transplants and allows more donor livers to be used. This indicates that the system is well-tolerated and can safely help preserve and evaluate donor livers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The OCS Liver System is unique because it offers a new way to preserve livers for transplantation. Unlike the traditional method of static cold storage, which simply keeps the liver on ice, the OCS Liver System actively maintains the organ in a warm, functioning state by mimicking the conditions inside the human body. This method allows for continuous monitoring and assessment of the liver's viability before transplantation. Researchers are excited about this treatment because it has the potential to improve transplant outcomes by increasing the number of usable organs and enhancing the quality of the transplanted liver.

What evidence suggests that the OCS Liver System is effective for liver preservation?

Research has shown that the OCS Liver System, which participants in this trial will experience, leads to better outcomes after liver transplants. It helps maintain donor liver health and increases their usability. Studies indicate that this system can restore liver function and reduce the risk of complications after surgery. The OCS Liver System allows more donor livers to be used successfully, benefiting both patients and doctors. Overall, it shows promise in making liver transplants safer and more effective. ^{1 2 4 6 7}

Who Is on the Research Team?

Ahmed Elbetanony, MD

Principal Investigator

TransMedics

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need a liver transplant and are on the waiting list. They must understand and agree to the study's process. People with sudden severe liver failure, those needing breathing support at the time of transplant, or anyone who has had an organ or bone marrow transplant before can't join.

Inclusion Criteria

Obtained informed consent

I am on the liver transplant waiting list.

Exclusion Criteria

I have had a solid organ or bone marrow transplant.

Ventilator dependent on day of transplant/donor organ offer

I am experiencing sudden severe liver failure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

OCS preserved livers are used for transplantation

OCS liver perfusion

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Long-term follow-up

Patient and graft survival are assessed

60 months

What Are the Treatments Tested in This Trial?

Interventions

• OCS Liver System

Trial Overview The OCS Liver System is being tested in this trial. It's designed to keep donor livers in good condition between donation and transplantation by preserving them outside the body in a specialized machine.

How Is the Trial Designed?

Group I: OCS Preserved Livers Experimental Treatment 1 Intervention

This is a single-arm trial of OCS preserved livers used for transplantation.

Who Is Running the Clinical Trial?

TransMedics

Lead Sponsor

Trials

24

Recruited

213,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34985503/

The OCS Liver PROTECT Randomized Clinical Trial Together these findings indicate that OCS Liver preservation is associated with superior posttransplant outcomes and increased donor liver use.

2. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2787486

Impact of Portable Normothermic Blood-Based Machine ... Together these findings indicate that OCS Liver preservation is associated with superior posttransplant outcomes and increased donor liver use.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02522871

Study Details | NCT02522871 | OCS Liver PROTECT Trial ... The OCS™ Liver PROTECT Trial is a two-armed, multicenter, prospective, randomized, controlled pivotal trial to evaluate the effectiveness and safety of the OCS ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8733869/

Impact of Portable Normothermic Blood-Based Machine ... Together these findings indicate that OCS Liver preservation is associated with superior posttransplant outcomes and increased donor liver use.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666967623000387

Effectiveness of machine perfusion in liver transplantation Machine perfusion has demonstrated remarkable efficacy in restoring donor liver function and reducing the incidence of postoperative complications in liver ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/P200031B.pdf

P200031 SSED - accessdata.fda.gov The OCS Liver was tested to demonstrate that it meets the requirements for medical device safety, including electrical safety. The system was ...

7. investors.transmedics.com investors.transmedics.com/news-releases/news-release-details/transmedics-announces-publication-ocstm-liver-protect-trial

TransMedics Announces Publication of OCS™ Liver ... The PROTECT trial showed superior short-term and mid-term clinical outcomes and higher numbers of donor livers used for transplant.