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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01630434




Registration number
NCT01630434
Ethics application status
Date submitted
25/06/2012
Date registered
28/06/2012
Date last updated
4/04/2023

Titles & IDs
Public title
International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation
Scientific title
Prospective, International, Multi-Center, Randomized Clinical Investigation of TransMedics Organ Care System (OCS LUNG) for Lung Preservation and Transplantation
Secondary ID [1] 0 0
OCS-LUN-03-2010
Universal Trial Number (UTN)
Trial acronym
INSPIRE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Preservation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - OCS Lung
Treatment: Devices - Cold flush and storage

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.

Active comparator: Cold flush and storage (Control Group) - Donor lungs will be preserved using cold flush and storage (control group)


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

Treatment: Devices: Cold flush and storage
Donor lungs will preserved using standard cold flush and storage
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Day 30 after transplantation
Secondary outcome [1] 0 0
Participants With International Society for Heart & Lung Transplantation (ISHLT) PGD Grade 3 at 72 Hours Post-transplantation
Timepoint [1] 0 0
72 hours after transplantation
Secondary outcome [2] 0 0
Participants With ISHLT PGD Grade 2 or 3 at 72 Hours Post-transplantation
Timepoint [2] 0 0
72 hours after transplantation
Secondary outcome [3] 0 0
Patient Survival at Day 30
Timepoint [3] 0 0
Day 30

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2016
Sample size
Target
Accrual to date
Final
320
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Darlinghurst
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
Belgium
State/province [8] 0 0
Leuven
Country [9] 0 0
Canada
State/province [9] 0 0
Alberta
Country [10] 0 0
France
State/province [10] 0 0
Marseille
Country [11] 0 0
France
State/province [11] 0 0
Paris
Country [12] 0 0
France
State/province [12] 0 0
Strasbourg
Country [13] 0 0
Germany
State/province [13] 0 0
Berlin
Country [14] 0 0
Germany
State/province [14] 0 0
Hamburg
Country [15] 0 0
Germany
State/province [15] 0 0
Hannover
Country [16] 0 0
Italy
State/province [16] 0 0
Padua
Country [17] 0 0
Spain
State/province [17] 0 0
Madrid
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Cambridge
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Middlesex

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
TransMedics
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT01630434
Trial related presentations / 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. doi: 10.1016/S2213-2600(18)30207-8.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Abbas Ardehali, MD
Address 0 0
Ronald Reagan Medical Center, UCLA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01630434