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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Heart Failure	Device: Organ Care System; Device: Cold Cardioplegia Solution	Phase 2; Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	128 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Prospective, Multicenter, Randomized, Clinical Investigation of TransMedics Organ Care System (OCS) for Cardiac Use
Study Start Date :	March 2009
Actual Primary Completion Date :	October 2013
Actual Study Completion Date :	November 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Organ Care System	Device: 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.; Other Name: OCS
Active Comparator: Cold cardioplegia solution	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

Outcome Measures

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Primary Outcome Measures :

1. 30-day patient survival following transplantation with the originally transplanted heart and no mechanical circulatory assist device at day 30 [ Time Frame: 30 days ]

Secondary Outcome Measures :

1. Incidence of all cardiac graft-related serious adverse events [ Time Frame: 30 days ]
2. 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 [ Time Frame: 30 day ]
3. Length of ICU stay [ Time Frame: 30 day ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90211
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New Jersey
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
France
Hospitalier Pitie-Salpetriere
Paris, France, 75013
Italy
Azienda Ospedaliera S. Maria della Misericordia
Udine, Italy, 33100
United Kingdom
Papworth Hospital
Cambridge, United Kingdom, CB23 3RE
Harefield Hospital
London Borough of Hillingdon, United Kingdom

Sponsors and Collaborators

TransMedics

University of California, Los Angeles

Columbia University

The Cleveland Clinic

Massachusetts General Hospital

Newark Beth Israel Medical Center

Cedars-Sinai Medical Center

Groupe Hospitalier Pitie-Salpetriere

Papworth Hospital

Azienda Ospedaliera S. Maria della Misericordia

Royal Brompton & Harefield NHS Foundation Trust

Indiana University

Investigators

Study Chair:	Abbas Ardehali, MD	University of California, Los Angeles

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	TransMedics
ClinicalTrials.gov Identifier:	NCT00855712 History of Changes
Other Study ID Numbers:	CAR-05-2008
First Posted:	March 4, 2009
Last Update Posted:	June 3, 2015
Last Verified:	May 2015

Keywords provided by TransMedics:

Heart Failure; Transplant; Warm Perfusion; Organ Care; Resting Mode

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases; Pharmaceutical Solutions; Cardioplegic Solutions