OCS Liver for Liver Transplant
(National OLP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of different liver preservation methods for transplants. Specifically, it compares livers preserved with a special machine called OCS, which maintains their health outside the body, to those preserved using other methods. The trial will gather data from patients who receive liver transplants to assess how these preservation techniques impact health outcomes. It seeks patients who have recently received a liver transplant. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking advancements in liver transplant preservation.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What is the safety track record for these treatments?
Research has shown that the OCS Liver system is safe and effective for patients. Studies have found that preserving livers with the OCS Liver leads to better outcomes after a transplant. Recipients of livers preserved with this system recovered more successfully and experienced fewer complications.
Strong evidence from past trials confirms the safety of this method. It has also increased the number of donor livers available for transplant, allowing patients to receive organs in better condition.
Research supports the safety and effectiveness of the OCS Liver system, making it a promising choice for those considering joining this registry.12345Why are researchers excited about this trial?
Researchers are excited about the US National OCS Liver Perfusion Registry because it explores a novel method of preserving donor livers for transplantation. Unlike traditional preservation methods that rely on cold storage, the OCS (Organ Care System) keeps livers warm and supplied with oxygen-rich blood, which can potentially improve the organ's condition and viability for transplant. This approach could lead to better patient outcomes and expand the pool of usable donor livers, addressing a critical shortage in organ availability.
What evidence suggests that this trial's treatments could be effective?
Research shows that the OCS (Organ Care System) Liver improves results for liver transplant patients. In this trial, some participants will receive livers stored using the OCS system, while others will receive livers preserved with other methods. Studies have found that storing donor livers with the OCS Liver leads to better transplant outcomes than traditional methods. Specifically, one study showed that patients who received livers stored with the OCS experienced better recovery after surgery, including higher survival rates and improved liver function post-transplant. The OCS system maintains the liver at normal body temperature and supplies it with oxygen and nutrients, keeping it healthy until the transplant. Overall, evidence supports that the OCS Liver enhances transplant success.13467
Who Is on the Research Team?
Ahmed Elbetanony, MD
Principal Investigator
TransMedics
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Data Collection
Data is collected on transplanted organs using OCS Liver perfusion and other preservation modalities
Follow-up
Participants are monitored for survival rates and clinical outcomes post-transplant
What Are the Treatments Tested in This Trial?
Interventions
- OCS Liver
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
The US National OLP Registry will enroll all liver transplant recipients who are transplanted with an OCS-perfused donor liver in the Registry.
Patients transplanted using other preservation modalities for clinical outcomes.
Find a Clinic Near You
Who Is Running the Clinical Trial?
TransMedics
Lead Sponsor
Citations
The OCS Liver PROTECT Randomized Clinical Trial
The trial compared outcomes for 300 recipients of livers preserved using either OCS (n = 153) or ICS (n = 147). Participants were actively ...
Impact of Portable Normothermic Blood-Based Machine ...
In this study, portable normothermic oxygenated machine perfusion of donor liver grafts resulted in improved outcomes after liver transplant and in more livers ...
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 ...
OCS Liver for HCPs
A prospective, pivotal, randomized trial to evaluate the effectiveness of the OCS Liver to preserve and assess donor livers intended for transplantation.
TransMedics® Organ Care System (OCS™) OCS™ Liver ...
conducted to evaluate the clinical impact of OCS Liver perfusion and monitoring on post-transplant clinical outcomes in liver transplantation from DBD and DCD ...
summary of safety and effectiveness data (ssed)
The TransMedics® Organ Care System (OCS™) Liver is a portable extracorporeal liver perfusion and monitoring system indicated for preservation and monitoring of.
7.
investors.transmedics.com
investors.transmedics.com/news-releases/news-release-details/transmedics-announces-publication-ocstm-liver-protect-trialTransMedics 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.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.