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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Organ Care System
Cold Cardioplegia Solution
Sponsored by
TransMedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Transplant, Warm Perfusion, Organ Care, Resting Mode

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA Medical Center
  • Cedars-Sinai Medical Center
  • Indiana University
  • Massachusetts General Hospital
  • Newark Beth Israel Medical Center
  • Columbia University Medical Center
  • Cleveland Clinic
  • Hospitalier Pitie-Salpetriere
  • Azienda Ospedaliera S. Maria della Misericordia
  • Papworth Hospital
  • Harefield Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Organ Care System

Cold cardioplegia solution

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of all cardiac graft-related serious adverse events
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
Length of ICU stay

Full Information

First Posted
March 3, 2009
Last Updated
June 4, 2020
Sponsor
TransMedics
Collaborators
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 NHS Foundation Trust, Azienda Ospedaliera S. Maria della Misericordia, Royal Brompton & Harefield NHS Foundation Trust, Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT00855712
Brief Title
Randomized Study of Organ Care System Cardiac for Preservation of Donated Hearts for Eventual Transplantation
Acronym
PROCEEDII
Official Title
Prospective, Multicenter, Randomized, Clinical Investigation of TransMedics Organ Care System (OCS) for Cardiac Use
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TransMedics
Collaborators
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 NHS Foundation Trust, Azienda Ospedaliera S. Maria della Misericordia, Royal Brompton & Harefield NHS Foundation Trust, Indiana University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Transplant, Warm Perfusion, Organ Care, Resting Mode

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Organ Care System
Arm Type
Experimental
Arm Title
Cold cardioplegia solution
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Organ Care System
Other Intervention Name(s)
OCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Cold Cardioplegia Solution
Intervention Description
This is the standard of care solutions used to arrest and preserve the donated heart during transport until arrival at recipient hospital
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Incidence of all cardiac graft-related serious adverse events
Time Frame
30 days
Title
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
Title
Length of ICU stay
Time Frame
30 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abbas Ardehali, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Study Chair
Facility Information:
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Hospitalier Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Azienda Ospedaliera S. Maria della Misericordia
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Papworth Hospital
City
Cambridge
ZIP/Postal Code
CB23 3RE
Country
United Kingdom
Facility Name
Harefield Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25888086
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.
Results Reference
derived

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

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