Randomized Study of Organ Care System Cardiac for Preservation of Donated Hearts for Eventual Transplantation

Not Applicable

Completed

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 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.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Arm && Interventions

Group	Intervention	Description
Organ Care System	Organ Care System	-
Cold cardioplegia solution	Cold Cardioplegia Solution	-

Primary Outcome Measures

Name	Time	Method
30-day patient survival following transplantation with the originally transplanted heart and no mechanical circulatory assist device at day 30	30 days

Secondary Outcome Measures

Name	Time	Method
Incidence of all cardiac graft-related serious adverse events	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	30 day
Length of ICU stay	30 day

Locations (11): Columbia University Medical Center
🇺🇸
New York, New York, United States
Harefield Hospital
🇬🇧
London, United Kingdom
Papworth Hospital
🇬🇧
Cambridge, United Kingdom
UCLA Medical Center
🇺🇸
Los Angeles, California, United States
Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Indiana University
🇺🇸
Indianapolis, Indiana, United States
Azienda Ospedaliera S. Maria della Misericordia
🇮🇹
Udine, Italy
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Hospitalier Pitie-Salpetriere
🇫🇷
Paris, France
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Newark Beth Israel Medical Center
🇺🇸
Newark, New Jersey, United States