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

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ClinicalTrials.gov Identifier: NCT01630434
Recruitment Status : Completed
First Posted : June 28, 2012
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
TransMedics

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Lung Preservation Device: OCS Lung Device: Cold flush and storage Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 316 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : April 2016
Arms and Interventions
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Arm Intervention/treatment
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).
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    This composite is a single outcome measure.


Secondary Outcome Measures :
  1. Incidence of International Society for Heart & Lung Transplantation (ISHLT) PGD Grade 3 at 72 hours post-transplantation [ Time Frame: 72 hours after transplantation ]
  2. Incidence of ISHLT PGD Grade 2 or 3 at 72 hours post-transplantation [ Time Frame: 72 hours after transplantation ]
  3. Patient survival at day 30 [ Time Frame: Day 30 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630434


Locations
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Sponsors and Collaborators
TransMedics
Investigators
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: TransMedics
ClinicalTrials.gov Identifier: NCT01630434    
Other Study ID Numbers: OCS-LUN-03-2010
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: May 2016