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

NCT01630434 | Completed Results DMC

• 1 other identifier: OCS-LUN-03-2010
• Study Type: interventional
• Target: 320
• Locations: 9 countries
• Sites: 21

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).

Conditions

Lung Preservation

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (3)

• Participants With International Society for Heart & Lung Transplantation (ISHLT) PGD Grade 3 at 72 Hours Post-transplantation

  72 hours after transplantation

• Participants With ISHLT PGD Grade 2 or 3 at 72 Hours Post-transplantation

  72 hours after transplantation

• Patient Survival at Day 30

  Day 30

Other Outcomes (2)

• Primary Safety Endpoint: Lung Graft-related Serious Adverse Events (LGRSAEs) Through 30-days Post-transplant Per Subject

  30 days post-transplant

• Long-term Survival: 24-month Survival

  24 months

Study Arms (2)

OCS Lung (Treatment Group)

EXPERIMENTAL

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

Cold flush and storage (Control Group)

ACTIVE COMPARATOR

Donor lungs will be preserved using cold flush and storage (control group)

Device: Cold flush and storage

Interventions

OCS Lung DEVICE

OCS Lung will be used to preserve the donor lungs (Treatment Group).

OCS Lung (Treatment Group)

Cold flush and storage DEVICE

Donor lungs will preserved using standard cold flush and storage

Also known as: Commercially available cold preservation solution

Cold flush and storage (Control Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior solid organ or bone marrow transplant
• Single lung recipient
• Multiple organ transplant recipient
• Chronic use of hemodialysis or diagnosis of chronic renal insufficiency

Sponsors & Collaborators

• TransMedics: lead

Study Sites (21)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

University of California at Los Angeles

Los Angeles, California, 90095, United States

Location

University of California at San Francisco

San Francisco, California, 94143, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

St. Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

Hospitals Leuven

Leuven, 3000, Belgium

Location

University of Alberta

Edmonton, Alberta, T6G 2C8, Canada

Location

University Hospitals of Marseille

Marseille, 13915, France

Location

Groupe Hospitalier Hopitaux Universitaries

Paris, 18 eme, France

Location

N.H.C Hospital Civil

Strasbourg, 67091, France

Location

German Heart Institute Berlin

Berlin, D-13353, Germany

Location

Universitäres Herzzentrum Hamburg GmbH

Hamburg, 20246, Germany

Location

Hannover Medical School

Hanover, D-300625, Germany

Location

University of Padua

Padua, 35128, Italy

Location

University Puerta de Hierro Hospital

Madrid, 28222, Spain

Location

Papworth Hospital

Cambridge, CB23 3 RE, United Kingdom

Location

Harefield Hospital

Middlesex, UB9 6JH, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 29650408 DERIVED

• 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.

  PMID: 25284600 DERIVED

Results Point of Contact

• Title: VP, Clinical Affairs
• Organization: TransMedics, Inc.

ldamme@transmedics.com

978.552.0900

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2012
• First Posted: June 28, 2012
• Study Start: November 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: April 1, 2016
• Last Updated: April 4, 2023
• Results First Posted: July 7, 2022

Record last verified: 2016-05

Locations

FR (3); CA (1); AU (1); DE (3); US (8); ES (1); GB (2); BE (1); IT (1)