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

  Show 21 Study Locations
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 October 02, 2014