Randomized Study of Organ Care System Cardiac for Preservation of Donated Hearts for Eventual Transplantation
NCT ID: NCT00855712
Last Updated: 2020-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
128 participants
INTERVENTIONAL
2009-03-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Organ Care System
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
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Registered male or female primary heart transplant candidate
* ≥18 years old
* Signed, written informed consent document and authorization to use and disclose protected health information
Donor Hearts
* \<60 years old
* Mean systolic blood pressure \>60 mmHg at the time of final heart assessment
* Satisfactory echocardiography assessment defined as:
* Ejection fraction \>40%
* Absence of severe segmental wall motion abnormalities
* Absence of left ventricular hypertrophy (inter ventricular septum and posterior wall thickness \<1.3 cm)
* Absence of valve abnormalities (trace to mild valvular regurgitation is acceptable)
Exclusion Criteria
* \>4 previous sternotomies
* Chronic renal failure as defined by chronic serum creatinine \>3.0 mg/dL for more than 2 weeks and/or requiring hemodialysis (except for hemodialysis or hemofiltration for fluid overload)
* Ventilator dependence at the time of transplant
* Use of a ventricular assist device for \> 30 days and the presence of any of the following: sepsis, intracranial hemorrhage or heparin induced thrombocytopenia
* Panel reactive antibodies \> 40% with a positive prospective cross match and/or virtual cross match
* Use of an investigational drug or device, other than OCS, during the study.
* Simultaneous transplant of non-heart allograft, except for concurrent kidney transplant
Donor Hearts
* Abnormal coronary angiogram defined as \>50% stenosis, requiring coronary bypass
* Donor-to-recipient body weight ratio of \<0.6
* Inotrope support at time of final heart assessment including, but not limited to:
* Dopamine \>10 ug/kg/min
* Dobutamine \> 10 ug/kg/min
* Milrinone \>0.3 ug/kg/min
* Epinephrine \> 0.03 ug/kg/min
* Norepinephrine \> 0.03 ug/kg/min
* Any bolus dose of the above prior to explants that would result in exceeding the above stated criteria
* Presence of any exclusion criterion based on the standard practice of the investigational site
18 Years
ALL
No
Sponsors
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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
Responsible Party
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Principal Investigators
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Abbas Ardehali, MD
Role: STUDY_CHAIR
University of California, Los Angeles
Locations
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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
Harefield Hospital
London, , United Kingdom
Countries
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References
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Ardehali A, Esmailian F, Deng M, Soltesz E, Hsich E, Naka Y, Mancini D, Camacho M, Zucker M, Leprince P, Padera R, Kobashigawa J; PROCEED II trial investigators. Ex-vivo perfusion of donor hearts for human heart transplantation (PROCEED II): a prospective, open-label, multicentre, randomised non-inferiority trial. Lancet. 2015 Jun 27;385(9987):2577-84. doi: 10.1016/S0140-6736(15)60261-6. Epub 2015 Apr 14.
Other Identifiers
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CAR-05-2008
Identifier Type: -
Identifier Source: org_study_id
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