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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

June 25, 2012
May 22, 2014
November 2011
August 2014   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT01630434 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation
Prospective, International, Multi-Center, Randomized Clinical Investigation of TransMedics Organ Care System (OCS LUNG) for Lung Preservation and Transplantation

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Preservation
  • Device: OCS Lung
    OCS Lung will be used to preserve the donor lungs (Treatment Group).
    Other Name: OCS Lung
  • Device: Cold flush and storage
    Donor lungs will preserved using standard cold flush and storage
    Other Name: Commercially available cold preservation solution
  • 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.
    Intervention: Device: OCS Lung
  • Active Comparator: Cold flush and storage (Control Group)
    Donor lungs will be preserved using cold flush and storage (control group)
    Intervention: Device: Cold flush and storage
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
264
October 2015
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States,   Australia,   Belgium,   Canada,   France,   Germany,   Italy,   Spain,   United Kingdom
 
NCT01630434
OCS-LUN-03-2010
Yes
TransMedics
TransMedics
Not Provided
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
TransMedics
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP