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

• Sponsor: TransMedics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00855712
• Collaborator: University of California, Los Angeles (Other), Columbia University (Other), The Cleveland Clinic (Other), Massachusetts General Hospital (Other), Newark Beth Israel Medical Center (Other), Cedars-Sinai Medical Center (Other), Groupe Hospitalier Pitie-Salpetriere (Other), Papworth Hospital NHS Foundation Trust (Other), Azienda Ospedaliera S. Maria della Misericordia (Other), Royal Brompton & Harefield NHS Foundation Trust (Other), Indiana University (Other)
• Enrollment: 128
• Locations: 11
• Arms: 2
• Duration (Months): 56
• Patients Per Site: 11.6
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: Organ Care System; Device: Cold Cardioplegia Solution	N/A

Study Design

• Study Type: Interventional
• 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: Mar 1, 2009
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

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 Names: 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

Primary Outcome Measures

1. 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

1. Incidence of all cardiac graft-related serious adverse events [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 [30 day]

3. Length of ICU stay [30 day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
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
5	Newark Beth Israel Medical Center	Newark	New Jersey	United States	07112
6	Columbia University Medical Center	New York	New York	United States	10032
7	Cleveland Clinic	Cleveland	Ohio	United States	44195
8	Hospitalier Pitie-Salpetriere	Paris		France	75013
9	Azienda Ospedaliera S. Maria della Misericordia	Udine		Italy	33100
10	Papworth Hospital	Cambridge		United Kingdom	CB23 3RE
11	Harefield Hospital	London		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 NHS Foundation Trust
• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TransMedics
• ClinicalTrials.gov Identifier: NCT00855712
• Other Study ID Numbers: CAR-05-2008
• First Posted: Mar 4, 2009
• Last Update Posted: Jun 9, 2020
• Last Verified: May 1, 2015

• Keywords provided by TransMedics: Heart Failure; Transplant; Warm Perfusion; Organ Care; Resting Mode
• Additional relevant MeSH terms: Heart Failure; Cardioplegic Solutions

Study Results

No Results Posted as of Jun 9, 2020