128
Participants
Start Date
March 31, 2009
Primary Completion Date
October 31, 2013
Study Completion Date
November 30, 2013
Organ Care System
The Organ Care System (OCS) is a portable organ perfusion and monitoring system intended to preserve a donated heart in a near normal physiologic beating state during transport for eventual transplantation into a recipient. The OCS maintains organ viability by providing a controlled environment that simulates near-normal physiological conditions, continuously perfusing the donated heart with warm, oxygenated blood, supplemented with the Solution Set. The blood is collected from the donor and continuously circulated to the organ in a closed circuit along with the Solution. The OCS preserves and monitors the organ's perfusion and metabolic state after explantation from a donor and connection to the device, during transportation to the recipient site, and until disconnection from the device.
Cold Cardioplegia Solution
This is the standard of care solutions used to arrest and preserve the donated heart during transport until arrival at recipient hospital
Columbia University Medical Center, New York
Azienda Ospedaliera S. Maria della Misericordia, Udine
Cleveland Clinic, Cleveland
Indiana University, Indianapolis
Hospitalier Pitie-Salpetriere, Paris
UCLA Medical Center, Los Angeles
Cedars-Sinai Medical Center, Los Angeles
Massachusetts General Hospital, Boston
Newark Beth Israel Medical Center, Newark
Papworth Hospital, Cambridge
Harefield Hospital, London
Lead Sponsor
University of California, Los Angeles
OTHER
Columbia University
OTHER
The Cleveland Clinic
OTHER
Massachusetts General Hospital
OTHER
Newark Beth Israel Medical Center
OTHER
Cedars-Sinai Medical Center
OTHER
Groupe Hospitalier Pitie-Salpetriere
OTHER
Papworth Hospital NHS Foundation Trust
OTHER_GOV
Azienda Ospedaliera S. Maria della Misericordia
OTHER
Royal Brompton & Harefield NHS Foundation Trust
OTHER
Indiana University
OTHER
TransMedics
INDUSTRY