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

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).

Study Overview

• Status: Completed
• Conditions: Lung Preservation
• Intervention / Treatment: Device: OCS Lung; Device: Cold flush and storage

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Commercially available cold preservation solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Day 30 after transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants With International Society for Heart & Lung Transplantation (ISHLT) PGD Grade 3 at 72 Hours Post-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.	72 hours after transplantation
Participants With ISHLT PGD Grade 2 or 3 at 72 Hours Post-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.	72 hours after transplantation
Patient Survival at Day 30		Day 30

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoint: Lung Graft-related Serious Adverse Events (LGRSAEs) Through 30-days Post-transplant Per Subject	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.	30 days post-transplant
Long-term Survival: 24-month Survival		24 months

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: June 25, 2012
• First Submitted That Met QC Criteria: June 26, 2012
• First Posted (Estimate): June 28, 2012

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: OCS-LUN-03-2010