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

This study has been completed.
Information provided by (Responsible Party):
TransMedics Identifier:
First received: June 25, 2012
Last updated: September 14, 2015
Last verified: September 2015

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

Further study details as provided by TransMedics:

Primary Outcome Measures:
  • A composite of patient survival at day 30 post transplantation, and absence of International Society for Heart & Lung Transplantation (ISHLT) Primary Graft Dysfunction (PGD3) Grade 3 within the first 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 ]

Enrollment: 316
Study Start Date: November 2011
Study Completion Date: August 2014
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


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

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 identifier: NCT01630434

  Hide Study Locations
United States, Arizona
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, California
University of California at Los Angeles
Los Angeles, California, United States, 90095
University of California at San Francisco
San Francisco, California, United States, 94143
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Australia, New South Wales
St. Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010
Hospitals Leuven
Leuven, Belgium, 3000
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2C8
University Hospitals of Marseille
Marseille, France, 13915
Groupe Hospitalier Hopitaux Universitaries
Paris, France, 18 eme
N.H.C Hospital Civil
Strasbourg, France, 67091
German Heart Institute Berlin
Berlin, Germany, D-13353
Universitäres Herzzentrum Hamburg GmbH
Hamburg, Germany, 20246
Hannover Medical School
Hannover, Germany, D-300625
University of Padua
Padua, Italy, 35128
University Puerta de Hierro Hospital
Madrid, Spain, 28222
United Kingdom
Papworth Hospital
Cambridge, United Kingdom, CB23 3 RE
Harefield Hospital
Middlesex, United Kingdom, UB9 6JH
Sponsors and Collaborators
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 by TransMedics

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: TransMedics Identifier: NCT01630434     History of Changes
Other Study ID Numbers: OCS-LUN-03-2010
Study First Received: June 25, 2012
Last Updated: September 14, 2015
Health Authority: United States: Food and Drug Administration processed this record on October 06, 2015