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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by TransMedics
Sponsor:
Information provided by (Responsible Party):
TransMedics
ClinicalTrials.gov Identifier:
NCT01630434
First received: June 25, 2012
Last updated: May 22, 2014
Last verified: May 2014
  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: October 2015
Estimated Primary Completion Date: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630434

  Hide Study Locations
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         
Universitäres Herzzentrum Hamburg GmbH Recruiting
Hamburg, Germany, 20246
Contact: Florian Wagner, MD    +49 40 741056121    Fl.wagner@uke.de   
Principal Investigator: Florian Wagner, MD         
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: May 22, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 25, 2014