Skip to main content
OpenTrials
Completed

NCT Number: NCT00855712

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospitalier Pitie-Salpetriere, Paris, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Organ Care system

Device

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

Cold Cardioplegia Solution

Device

This is the standard of care solutions used to arrest and preserve the donated heart during transport until arrival at recipient hospital

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

TransMedics

Industry

Collaborators

  • Azienda Ospedaliera S. Maria della Misericordia
  • Cedars-Sinai Medical Center
  • Columbia University
  • Groupe Hospitalier Pitie-Salpetriere
  • Indiana University
  • Massachusetts General Hospital
  • Newark Beth Israel Medical Center
  • Papworth Hospital NHS Foundation Trust
  • Royal Brompton & Harefield NHS Foundation Trust
  • The Cleveland Clinic
  • University of California, Los Angeles

Registry information

Official study title

Prospective, Multicenter, Randomized, Clinical Investigation of TransMedics Organ Care System (OCS) for Cardiac Use

Acronym: PROCEEDII

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Mar 4, 2009
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.