Status:
COMPLETED
Randomized Study of Organ Care System Cardiac for Preservation of Donated Hearts for Eventual Transplantation
Lead Sponsor:
TransMedics
Collaborating Sponsors:
University of California, Los Angeles
Columbia University
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00855712
Start Date
March 1 2009
End Date
November 1 2013
Last Update
June 9 2020
Active Locations (11)
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1
UCLA Medical Center
Los Angeles, California, United States, 90095
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90211
3
Indiana University
Indianapolis, Indiana, United States, 46202
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114