Randomized Study of Organ Care System Cardiac for Preservation of Donated Hearts for Eventual Transplantation
Completed · Not applicable
Conditions studied: Heart Failure
In brief
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.
Key facts
- Study ID
- NCT00855712
- Run by
- TransMedics
- People needed
- 128
- Starts
- 2009-03-01
- Expected to finish
- 2013-11-01
- Last updated by the study team
- 2020-06-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Recipient Day of Transplant
- 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)
You may not qualify if…
- Recipient Day of Transplant
- >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
Where it is running
- 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
Full record on ClinicalTrials.gov
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