Clinical trial NCT01630434: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Preservation
Lead sponsor: TransMedics
Sponsor class: INDUSTRY
First posted: 2012-06-28
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: 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.
timeFrame: Day 30 after transplantation
Secondary outcomes:
measure: Participants With International Society for Heart & Lung Transplantation (ISHLT) PGD Grade 3 at 72 Hours Post-transplantation
timeFrame: 72 hours after transplantation
measure: Participants With ISHLT PGD Grade 2 or 3 at 72 Hours Post-transplantation
timeFrame: 72 hours after transplantation
measure: Patient Survival at Day 30
timeFrame: Day 30
Other outcomes:
measure: Primary Safety Endpoint: Lung Graft-related Serious Adverse Events (LGRSAEs) Through 30-days Post-transplant Per Subject
timeFrame: 30 days post-transplant
measure: Long-term Survival: 24-month Survival
timeFrame: 24 months
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: University of California at Los Angeles
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital
state: New South Wales
city: Leuven
country: Belgium
facility: Hospitals Leuven
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Marseille
country: France
facility: University Hospitals of Marseille
city: Paris
country: France
facility: Groupe Hospitalier Hopitaux Universitaries
city: Strasbourg
country: France
facility: N.H.C Hospital Civil
city: Berlin
country: Germany
facility: German Heart Institute Berlin
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg GmbH
city: Hannover
country: Germany
facility: Hannover Medical School
city: Padua
country: Italy
facility: University of Padua
city: Madrid
country: Spain
facility: University Puerta de Hierro Hospital
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
city: Middlesex
country: United Kingdom
facility: Harefield Hospital
Study officials:
affiliation: Ronald Reagan Medical Center, UCLA
name: Abbas Ardehali, MD
role: STUDY_DIRECTOR
affiliation: UZ Leuven, Belgium
name: Dirk van Raemodonck, MD
role: STUDY_DIRECTOR
affiliation: Hannover Medical Center, Germany
name: Gregor Warnecke, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.