Clinical trial NCT00855712: Randomized Study of Organ Care System Cardiac for Preservation of Donated Hearts for Eventual Transplantation
Official title: Prospective, Multicenter, Randomized, Clinical Investigation of TransMedics Organ Care System (OCS) for Cardiac Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Transplant
Warm Perfusion
Organ Care
Resting Mode
Lead sponsor: TransMedics
Sponsor class: INDUSTRY
Collaborators: name: University of California, Los Angeles
name: Columbia University
name: The Cleveland Clinic
name: Massachusetts General Hospital
name: Newark Beth Israel Medical Center
name: Cedars-Sinai Medical Center
name: Groupe Hospitalier Pitie-Salpetriere
name: Papworth Hospital NHS Foundation Trust
name: Azienda Ospedaliera S. Maria della Misericordia
name: Royal Brompton & Harefield NHS Foundation Trust
name: Indiana University
First posted: 2009-03-04
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 30-day patient survival following transplantation with the originally transplanted heart and no mechanical circulatory assist device at day 30
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of all cardiac graft-related serious adverse events
timeFrame: 30 days
measure: 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
timeFrame: 30 day
measure: Length of ICU stay
timeFrame: 30 day
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Paris
country: France
facility: Hospitalier Pitie-Salpetriere
city: Udine
country: Italy
facility: Azienda Ospedaliera S. Maria della Misericordia
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
city: London
country: United Kingdom
facility: Harefield Hospital
Study officials:
affiliation: University of California, Los Angeles
name: Abbas Ardehali, MD
role: STUDY_CHAIR
References:
citation: 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.