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Lung Preservation | International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation

Lung Preservation research study

What is the primary objective of this study?

A prospective, international, multi-center, randomized controlled trial comparing preservation of donor lungs using OCS-Lung perfusion device (Treatment Group) to cold flush and storage (Control Group).

Who is eligible to participate?

Inclusion Criteria: - Registered primary double-lung transplant candidate - Age > or equal to 18 - Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information Exclusion Criteria: - Prior solid organ or bone marrow transplant - Single lung recipient - Multiple organ transplant recipient - Chronic use of hemodialysis or diagnosis of chronic renal insufficiency

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Lung Preservation

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:OCS LungOCS Lung will be used to preserve the donor lungs (Treatment Group).

Device:Cold flush and storageDonor lungs will preserved using standard cold flush and storage

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

OCS Lung (Treatment Group)The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs.

Cold flush and storage (Control Group)Donor lungs will be preserved using cold flush and storage (control group)

Study Status

Completed

Start Date: November 2011

Completed Date: April 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome:

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Abbas Ardehali, MD

Lead Sponsor: TransMedics

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01630434

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