OCS Liver Preservation for Liver Transplant

Recruiting at 14 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

9 Participants Needed

Trial Summary

What is the purpose of this trial?

Evaluate the safety and effectiveness of the OCS Liver System to preserve, optimize the condition, and assess levers from DCD donors.

Research Team

Ahmed Elbetanony, MD

Principal Investigator

TransMedics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+