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

• ClinicalTrials.gov Identifier: NCT01630434
• Recruitment Status: Completed
• First Posted: June 28, 2012
• Results First Posted: July 7, 2022
• Last Update Posted: July 7, 2022
• Sponsor: TransMedics
• Information provided by (Responsible Party): TransMedics

Tracking Information

• First Submitted Date: June 25, 2012
• First Posted Date: June 28, 2012
• Results First Submitted Date: April 6, 2022
• Results First Posted Date: July 7, 2022
• Last Update Posted Date: July 7, 2022
• Study Start Date: November 2011
• Actual Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 10, 2022)

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. Primary graft dysfunction is graded on a scale of 0 to 3 according to the 2005 ISHLT PGD grading consensus. Grade 0 is considered the least severe and grade 3 is considered a more severe outcome.

• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: June 10, 2022)

• Participants With International Society for Heart & Lung Transplantation (ISHLT) PGD Grade 3 at 72 Hours Post-transplantation [ Time Frame: 72 hours after transplantation ]
  Primary graft dysfunction is graded on a scale of 0 to 3 according to the 2005 ISHLT PGD grading consensus. Grade 0 is considered the least severe and grade 3 is considered a more severe outcome.
• Participants With ISHLT PGD Grade 2 or 3 at 72 Hours Post-transplantation [ Time Frame: 72 hours after transplantation ]
  Primary graft dysfunction is graded on a scale of 0 to 3 according to the 2005 ISHLT PGD grading consensus. Grade 0 is considered the least severe and grade 3 is considered a more severe outcome.
• Patient Survival at Day 30 [ Time Frame: Day 30 ]

• Original Secondary Outcome Measures: Not Provided

Current Other Pre-specified Outcome Measures (submitted: June 10, 2022)

• Primary Safety Endpoint: Lung Graft-related Serious Adverse Events (LGRSAEs) Through 30-days Post-transplant Per Subject [ Time Frame: 30 days post-transplant ]
  An LGRSAE event is defined as the occurrence of any of the following four categories of adverse events that are also serious; acute rejection, respiratory failure, bronchial anastomotic complication, and major pulmonary-related infection.
• Long-term Survival: 24-month Survival [ Time Frame: 24 months ]

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation
• Official Title: Prospective, International, Multi-Center, Randomized Clinical Investigation of TransMedics Organ Care System (OCS LUNG) for Lung Preservation and Transplantation
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Lung Preservation

Intervention

• Device: OCS Lung
  OCS Lung will be used to preserve the donor lungs (Treatment Group).
• Device: Cold flush and storage
  Donor lungs will preserved using standard cold flush and storage
  Other Name: Commercially available cold preservation solution

Study Arms

• 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

Publications *

• Warnecke G, Van Raemdonck D, Smith MA, Massard G, Kukreja J, Rea F, Loor G, De Robertis F, Nagendran J, Dhital KK, Moradiellos Diez FJ, Knosalla C, Bermudez CA, Tsui S, McCurry K, Wang IW, Deuse T, Leseche G, Thomas P, Tudorache I, Kuhn C, Avsar M, Wiegmann B, Sommer W, Neyrinck A, Schiavon M, Calabrese F, Santelmo N, Olland A, Falcoz PE, Simon AR, Varela A, Madsen JC, Hertz M, Haverich A, Ardehali A. Normothermic ex-vivo preservation with the portable Organ Care System Lung device for bilateral lung transplantation (INSPIRE): a randomised, open-label, non-inferiority, phase 3 study. Lancet Respir Med. 2018 May;6(5):357-367. doi: 10.1016/S2213-2600(18)30136-X. Epub 2018 Apr 9. Erratum In: Lancet Respir Med. 2018 Jun;6(6):e27.
• Bozso S, Freed D, Nagendran J. Successful transplantation of extended criteria lungs after prolonged ex vivo lung perfusion performed on a portable device. Transpl Int. 2015 Feb;28(2):248-50. doi: 10.1111/tri.12474. Epub 2014 Oct 27. No abstract available.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 10, 2022): 320
• Original Enrollment: Not Provided
• Actual Study Completion Date: April 2016
• Actual Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Belgium, Canada, France, Germany, Italy, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT01630434
• Other Study ID Numbers: OCS-LUN-03-2010
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: TransMedics
• Original Responsible Party: [Redacted]
• Current Study Sponsor: TransMedics
• Original Study Sponsor: [Redacted]
• Collaborators: Not Provided

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

• PRS Account: TransMedics
• Verification Date: May 2016