The purpose of the study is to compare survival of both patients and newly transplanted hearts following heart transplantation among patients who were transplanted with donated hearts preserved on ice and those who were transplanted with donated hearts using the Organ Care System (OCS). The Organ care system preserves the hearts in a warm blood perfused beating state. The study also compares the number of rejection episodes, heart related adverse events, ICU time, and ventilation time between the two groups. The study is considered a success if survival in the OCS group was not inferior to the ice group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
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.
This is the standard of care solutions used to arrest and preserve the donated heart during transport until arrival at recipient hospital
UCLA Medical Center
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Indiana University
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Hospitalier Pitie-Salpetriere
Paris, France
Azienda Ospedaliera S. Maria della Misericordia
Udine, Italy
Papworth Hospital
Cambridge, United Kingdom
...and 1 more locations
30-day patient survival following transplantation with the originally transplanted heart and no mechanical circulatory assist device at day 30
Time frame: 30 days
Incidence of all cardiac graft-related serious adverse events
Time frame: 30 days
Incidence of biopsy proven ISHLT grade 2R or 3R acute rejection on any of the surveillance endomyocardial biopsies or clinically symptomatic rejection requiring augmentation of immunosuppressive therapy during the 30 day follow up
Time frame: 30 day
Length of ICU stay
Time frame: 30 day
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