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

Completed · Not applicable

Conditions studied: Lung Preservation

In brief

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).

Key facts

Study ID

NCT01630434

Run by

TransMedics

People needed

320

Starts

2011-11-01

Expected to finish

2016-04-01

Last updated by the study team

2023-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Prior solid organ or bone marrow transplant
• Single lung recipient
• Multiple organ transplant recipient
• Chronic use of hemodialysis or diagnosis of chronic renal insufficiency

Where it is running

• St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• University of California at Los Angeles — Los Angeles, California, United States
• University of California at San Francisco — San Francisco, California, United States
• Indiana University — Indianapolis, Indiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• St. Vincent's Hospital — Darlinghurst, New South Wales, Australia
• Hospitals Leuven — Leuven, Belgium
• University of Alberta — Edmonton, Alberta, Canada
• University Hospitals of Marseille — Marseille, France
• Groupe Hospitalier Hopitaux Universitaries — Paris, France
• N.H.C Hospital Civil — Strasbourg, France
• German Heart Institute Berlin — Berlin, Germany
• Universitäres Herzzentrum Hamburg GmbH — Hamburg, Germany
• Hannover Medical School — Hanover, Germany
• University of Padua — Padua, Italy
• University Puerta de Hierro Hospital — Madrid, Spain
• Papworth Hospital — Cambridge, United Kingdom
• Harefield Hospital — Middlesex, United Kingdom

Full record on ClinicalTrials.gov

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