Lung PreservationINSPIRENCT01630434
International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation
A study testing OCS Lung and Cold flush and storage in people with Lung Preservation, run by TransMedics at 21 sites in 9 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Preservation
- What is being tested?
- OCS Lung and Cold flush and storage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 21 sitesin 9 countries
- Study dates
- Nov 2011to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prior solid organ or bone marrow transplant
- Single lung recipient
- Multiple organ transplant recipient
- Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
Trial locations and contacts
21 sites in 9 countries.
21 sites in 9 countries
United States8 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Cleveland Clinic
Cleveland, Ohio, 44195
Indiana University
Indianapolis, Indiana, 46202
University of California at Los Angeles
Los Angeles, California, 90095
University of Minnesota
Minneapolis, Minnesota, 55455
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
University of California at San Francisco
San Francisco, California, 94143
France3 sites
University Hospitals of Marseille
Marseille, 13915
Groupe Hospitalier Hopitaux Universitaries
Paris, 18 eme
N.H.C Hospital Civil
Strasbourg, 67091
Germany3 sites
German Heart Institute Berlin
Berlin, D-13353
Universitäres Herzzentrum Hamburg GmbH
Hamburg, 20246
Hannover Medical School
Hanover, D-300625
United Kingdom2 sites
Papworth Hospital
Cambridge, CB23 3 RE
Harefield Hospital
Middlesex, UB9 6JH
About this study
Official title: 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).
- Conditions
- Lung Preservation
- Being tested
- OCS Lung, Cold flush and storage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCS LungDevice
OCS Lung will be used to preserve the donor lungs (Treatment Group).
Cold flush and storageDevice
Also called Commercially available cold preservation solution
Donor lungs will preserved using standard cold flush and storage
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: OCS Lung |
| Cold flush and storage (Control Group) | Active comparator | Donor lungs will be preserved using cold flush and storage (control group) Receives: Device: Cold flush and storage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 30 after transplantation
Secondary outcomes (3)
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.
Measured: 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.
Measured: 72 hours after transplantation
Patient Survival at Day 30
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startNov 2011
- Primary completionSep 2014
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung PreservationStudies of the same condition, open and under way.
- More trials run by TransMedicsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- TransMedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abbas Ardehali, MD, Study director, Ronald Reagan Medical Center, UCLADirk van Raemodonck, MD, Study director, UZ Leuven, BelgiumGregor Warnecke, MD, Study director, Hannover Medical Center, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630434
- Sponsor's protocol ID
- OCS-LUN-03-2010
- Acronym
- INSPIRE
- Status last verified
- May 2016
- First submitted
- 25 Jun 2012
- Last updated
- 4 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 29650408Bozso 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.
PubMed 25284600
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, International, Multi-Center, Randomized Clinical Investigation of TransMedics Organ Care System (OCS LUNG) for Lung Preservation and Transplantation
- ClinicalTrials.gov ID
- NCT01630434
- Acronym / sponsor ID
- INSPIRE / OCS-LUN-03-2010
- Conditions
- Lung Preservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- TransMedicsIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 28 Jun 2012 (estimated)
- Results
- Posted 7 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCS Lung (Treatment Group) | Experimental | Device: OCS LungThe 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. |
| Cold flush and storage (Control Group) | Active comparator | Device: Cold flush and storageDonor lungs will be preserved using cold flush and storage (control group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Prior solid organ or bone marrow transplant
- Single lung recipient
- Multiple organ transplant recipient
- Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCS LungOCS Lung will be used to preserve the donor lungs (Treatment Group). | Device | OCS Lung (Treatment Group) |
| Cold flush and storageAlso: Commercially available cold preservation solutionDonor lungs will preserved using standard cold flush and storage | Device | Cold flush and storage (Control Group) |
Primary outcome
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.
3 secondary outcomes
Participants With International Society for Heart & Lung Transplantation (ISHLT) PGD Grade 3 at 72 Hours Post-transplantation
Time frame: 72 hours after transplantation
Participants With ISHLT PGD Grade 2 or 3 at 72 Hours Post-transplantation
Time frame: 72 hours after transplantation
Patient Survival at Day 30
Time frame: Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29650408Warnecke 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.
- Derived from this study: PubMed 25284600Bozso 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abbas Ardehali, MD study director
Ronald Reagan Medical Center, UCLA
Dirk van Raemodonck, MD study director
UZ Leuven, Belgium
Gregor Warnecke, MD study director
Hannover Medical Center, Germany
21 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCS Lung and Cold flush and storage in people with Lung Preservation, run by TransMedics at 21 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, France, Germany, United Kingdom, Australia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Day 30 after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01630434, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.