Topics

OCS Liver PROTECT Continued Access Protocol

2019-12-10 01:20:58 | BioPortfolio

Summary

Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.

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:

1. Donor age equal to or greater than 40 years old, or

2. Expected cross clamp time of 6 hours or greater, or

3. Donor after circulatory death (DCD) with age less than or equal to 55 years; or

4. 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

Conditions

Liver Transplant

Intervention

OCS Liver System

Status

Not yet recruiting

Source

TransMedics

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-12-10T01:20:58-0500

Clinical Trials [4706 Associated Clinical Trials listed on BioPortfolio]

The TOGETHER Project - Liver

To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.

OCS Liver System DCD Trial

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

Liver Transplants in People With HIV Infection

HIV infected people are at increased risk for liver disease and failure, leading to the need for a liver transplant. Many HIV infected people are refused a transplant because it has been ...

Prediction of Hepatitis C Recurrence in Liver Transplant Recipients

The purpose of the study is to look at cells of the immne system to see if the cells are different among people with different risk factors that have received a liver translant. We will en...

Controlled Attenuation Parameter (CAP) in Liver Allografts

The primary aim is to determine the accuracy of CAP in the quantification of liver steatosis using liver biopsies as reference. Secondarily, investigators will correlate transient elastogr...

PubMed Articles [13649 Associated PubMed Articles listed on BioPortfolio]

Macrosteatotic Allografts and Obese Recipients Have Nearly Equal Negative Impact on Liver Transplant Survival.

Our aim was to evaluate liver transplant outcomes involving donors with high macrosteatosis grafts in the obese modern liver transplant recipient population.

The Differential Impact of Age Among Liver Transplant Candidates With and Without HCC.

Hepatocellular carcinoma (HCC) is the fastest rising cause of cancer-related mortality in the US and a leading indication for liver transplantation (LT). Changes in chronic liver disease burden have l...

Tuberculosis treatment with a three drug rifamycin-free regimen in liver transplant recipients.

Active tuberculosis (TB) is a severe and potentially fatal complication of liver transplantation (1). The management of TB in liver transplant (LT) recipients is challenging not only because of the se...

Obesity and Liver Disease: The New Era of Liver Transplantation.

Non-alcoholic fatty liver disease (NAFLD) is a spectrum that ranges from simple steatosis to steatohepatitis, advanced fibrosis and cirrhosis. NAFLD is now the most common chronic liver disease in man...

Getting a "Grip" on Sarcopenia for the Liver Transplant Candidate: Time to Focus on Muscle Function.

Sarcopenia is common in patients with advanced liver disease. It diminishes quality of life and is implicated in increased wait-list mortality, post-transplant complications, and post-transplant morta...

Medical and Biotech [MESH] Definitions

Sudden liver failure in the presence of underlying compensated chronic LIVER DISEASE (e.g., LIVER CIRRHOSIS; HEPATITIS; and liver injury and failure) due to a precipitating acute hepatic insult.

Final stage of a liver disease when the liver failure is irreversible and LIVER TRANSPLANTATION is needed.

Experimentally induced chronic injuries to the parenchymal cells in the liver to achieve a model for LIVER CIRRHOSIS.

Blood tests that are used to evaluate how well a patient's liver is working and also to help diagnose liver conditions.

A spectrum of clinical liver diseases ranging from mild biochemical abnormalities to ACUTE LIVER FAILURE, caused by drugs, drug metabolites, and chemicals from the environment.

More From BioPortfolio on "OCS Liver PROTECT Continued Access Protocol"

Quick Search

Relevant Topics

Hepatology
Hepatology is the study of liver, gallbladder, biliary tree, and pancreas, and diseases associated with them. This includes viral hepatitis, alcohol damage, cirrhosis and cancer. As modern lifestyles change, with alcoholism and cancer becoming more promi...

Transplantation
Organ transplantation is the moving of an organ from one body to another or from a donor site to another location on the patient's own body, for the purpose of replacing the recipient's damaged or absent organ. The emerging field of regenerative ...


Searches Linking to this Trial