International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation (INSPIRE)

This study is currently recruiting participants.
Verified November 2013 by TransMedics
Sponsor:
Information provided by (Responsible Party):
TransMedics
ClinicalTrials.gov Identifier:
NCT01630434
First received: June 25, 2012
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

A prospective, international, multi-center, randomized controlled trial comparing preservation of donor lungs using OCS-Lung perfusion device (Treatment Group) to cold flush and storage (Control Group).


Condition Intervention Phase
Lung Preservation
Device: OCS Lung
Device: Cold flush and storage
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, International, Multi-Center, Randomized Clinical Investigation of TransMedics Organ Care System (OCS LUNG) for Lung Preservation and Transplantation

Resource links provided by NLM:


Further study details as provided by TransMedics:

Primary Outcome Measures:
  • Primary study endpoint is a composite of patient and graft survival at day 30 post transplantation, and absence of International Society for Heart & Lung Transplantation (ISHLT) Primary Graft Dysfunction (PGD3) Grade 3 at 72 hours post-transplantation. [ Time Frame: Day 30 after transplantation ] [ Designated as safety issue: No ]
    This composite is a single outcome measure.


Secondary Outcome Measures:
  • Incidence of International Society for Heart & Lung Transplantation (ISHLT) PGD Grade 3 at 72 hours post-transplantation [ Time Frame: 72 hours after transplantation ] [ Designated as safety issue: No ]
  • Incidence of ISHLT PGD Grade 2 or 3 at 72 hours post-transplantation [ Time Frame: 72 hours after transplantation ] [ Designated as safety issue: No ]
  • Patient survival at day 30 [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
  • Graft survival at day 30 [ Time Frame: Day 30 ] [ Designated as safety issue: No ]

Estimated Enrollment: 264
Study Start Date: November 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OCS Lung (Treatment Group)
The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs.
Device: OCS Lung
OCS Lung will be used to preserve the donor lungs (Treatment Group).
Other Name: OCS Lung
Active Comparator: Cold flush and storage (Control Group)
Donor lungs will be preserved using cold flush and storage (control group)
Device: Cold flush and storage
Donor lungs will preserved using standard cold flush and storage
Other Name: Commercially available cold preservation solution

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Registered primary double-lung transplant candidate
  • Age > or equal to 18
  • Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information

Exclusion Criteria:

  • Prior solid organ or bone marrow transplant
  • Single lung recipient
  • Multiple organ transplant recipient
  • Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630434

Locations
United States, Arizona
St. Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: Michael A. Smith, MD    602-406-4000    Michael.Smith011@DignityHealth.org   
Principal Investigator: Michael A Smith, MD         
United States, California
University of California at Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Abbas Ardehali, MD    310-825-5841    AArdehali@mednet.ucla.edu   
Principal Investigator: Abbas Ardehali, MD         
University of California at San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Jasleen Kukreja, MD    415-885-3882    Jasleen.Kukreja@ucsfmedctr.org   
Principal Investigator: Jasleen Kukreja, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: I-wen Wang, MD       IWang@IUHealth.org   
Principal Investigator: I-wen Wang, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Janice Camuso, RN    617-643-0166    JMCAMUSO@mgh.harvard.edud.edu   
Principal Investigator: Jose P Garcia, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Carol Toninato, RN    612-625-4941    ctoninato@umphysicians.umn.edu   
Principal Investigator: Gabriel Loor, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Kennth McCurry, MD    216-445-9303    mccurrk@ccf.org   
Principal Investigator: Kenneth McCurry, MD         
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Christian Bermudez, MD    412-648-6200    bermudezc@upmc.edu   
Principal Investigator: Christian Bermudez, MD         
Australia, New South Wales
St. Vincent's Hospital Recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact: Kumud Dhital, MD    +61 2 8382 3069    kdhital@stvincents.com.au   
Principal Investigator: Kumud Dhital, MD         
Belgium
Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Contact: Van Raemdonck, MD    3216346823    dirk.vanraemdonck@uzleuven.be   
Principal Investigator: Van Raemdonck, MD         
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2C8
Contact: Jayan Nagendran, MD    (780) 407-6327    jayan@ualberta.ca   
Principal Investigator: Jayan Nagendran, MD         
France
University Hospitals of Marseille Recruiting
Marseille, France, 13915
Contact: Pascal Thomas, Prof., M.D.    33 491966013    mailto:PascalAlexandre.Thomas@ap-hm.fr   
Principal Investigator: Pascal Thomas, Prof., M.D.         
Groupe Hospitalier Hopitaux Universitaries Recruiting
Paris, France, 18 eme
Contact: Guy Leseche, MD    01133153810473    guy.leseche@bch.aphp.fr   
Principal Investigator: Guy Leseche, MD         
N.H.C Hospital Civil Recruiting
Strasbourg, France, 67091
Contact: Gilbert Massard, MD    01133388116202    Gilbert.Massard@chru-strasbourg.fr   
Principal Investigator: Gilbert Massard, MD         
Germany
German Heart Institute Berlin Recruiting
Berlin, Germany, D-13353
Contact: Christoph Knosalla, MD, PHD    493045932000    knosalla@dhzb.de   
Principal Investigator: Christoph Knosalla, MD, PHD         
Hannover Medical School Recruiting
Hannover, Germany, D-300625
Contact: Gregor Warnecke, MD    011495115326590    warnecke.gregor@mh-hannover.de   
Principal Investigator: Gregor Warnecki, MD         
Italy
University of Padua Recruiting
Padua, Italy, 35128
Contact: Federico Rea, MD    011390498212203    federico.rea@unipd.it   
Principal Investigator: Federico Rea, MD         
Spain
University Puerta de Hierro Hospital Recruiting
Madrid, Spain, 28222
Contact: Andres Varella, MD    01134901222227    avarelade.hpth@salud.madrid.org   
Principal Investigator: Andres Varella, MD         
United Kingdom
Papworth Hospital Recruiting
Cambridge, United Kingdom, CB23 3 RE
Contact: Steven Tsui, MD    011441480364297    steven.tsui@papworth.nhs.uk   
Principal Investigator: Steven Tsui, MD         
Harefield Hospital Recruiting
Middlesex, United Kingdom, UB9 6JH
Contact: Fabio DeRobertis, MD    011441895828715    f.derobertis@rbht.nhs.uk   
Principal Investigator: Fabio DeRobertis, MD         
Sponsors and Collaborators
TransMedics
Investigators
Study Director: Abbas Ardehali, MD Ronald Reagan Medical Center, UCLA
Study Director: Dirk van Raemodonck, MD UZ Leuven, Belgium
Study Director: Gregor Warnecke, MD Hannover Medical Center, Germany
  More Information

No publications provided

Responsible Party: TransMedics
ClinicalTrials.gov Identifier: NCT01630434     History of Changes
Other Study ID Numbers: OCS-LUN-03-2010
Study First Received: June 25, 2012
Last Updated: November 27, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 15, 2014