Lung TransplantEXPANDLungNCT01963780
International EXPAND Lung Pivotal Trial
A study testing OCS Lung Preservation in people with Lung Transplant, run by TransMedics at 11 sites in 4 countries.
Trial summary
To evaluate the safety and effectiveness of the OCS™ Lung to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria for transplantation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Transplant
- What is being tested?
- OCS Lung Preservation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 11 sitesin 4 countries
- Study dates
- Nov 2013to Apr 2018
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one of the following:
- Donor PaO2/FiO2 ≤ 300 mmHg; or
- Expected ischemic time > 6 hours; or
- Donor after Cardiac Death (DCD donor); or
- Donor age ≥55 years old
Who cannot join
- • Presence of moderate to severe traumatic lung injury with air and/or blood leak
- Presence of confirmed active pneumonia or persistent purulent secretions on repeated bronchoscopy evaluation or ET suction
- Previous history of pulmonary disease
- Multiple transfusions of >10 pRBCs units
- ABO incompatibility
- Tobacco history of >20 pack years
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
United States8 sites
Emory
Atlanta, Georgia, 30322
Massachusetts General Hospital
Boston, Massachusetts, 02114
Duke University
Durham, North Carolina, 27710
University of California at Los Angeles
Los Angeles, California, 90095
University of Minnesota
Minneapolis, Minnesota, 55455
Temple University Hospital
Philadelphia, Pennsylvania, 19140
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: International Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Lung For Recruiting, Preserving and Assessing Expanded Criteria Donor Lungs for Transplantation (EXPAND Trial)
To evaluate the safety and effectiveness of the OCS™ Lung to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.
Read the detailed description
The OCS™ Lung is to be used to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria from one or more of the following characteristics:
- Donor PaO2/FiO2 ≤ 300 mmHg; or
- Expected ischemic time > 6 hours; or
- Donor after Cardiac Death (DCD donor); or
- Donor age ≥55 years old
- Conditions
- Lung Transplant
- Being tested
- OCS Lung Preservation
- Keywords
- lung transplantation, lung preservation, breathing lung transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCS Lung PreservationDevice
| Study group | Role | What they receive |
|---|---|---|
| OCS Lung Tx. | Experimental | A prospective, pivotal single arm trial. Receives: Device: OCS Lung Preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Composite Endpoint of Patient Survival at Day-30 Post Transplant and Absence of Primary Graft Dysfunction (PGD) Grade 3 During the First 72 Hours Post Lung Transplant
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: 30 days post lung transplantation
Secondary outcomes (2)
Number of Participants With ISHLT Primary Graft Dysfunction (PGD) Grade 2 or 3 at T72 Hours Post Lung 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 post lung transplantation
Number of Participants With Primary Graft Dysfunction Grade 3 at T72 Hours
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 post lung transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startNov 2013
- Primary completion22 Nov 2016
- Study completionApr 2018
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 (1)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- TransMedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abbas Ardehali, MD, Principal investigator, University of California, Los AngelesDirk Van Raemdonck, MD, PhD, Principal investigator, University of Leuven Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963780
- Sponsor's protocol ID
- OCS-LUN-012013
- Acronym
- EXPANDLung
- Status last verified
- Apr 2018
- First submitted
- 4 Sep 2013
- Last updated
- 7 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Loor G, Warnecke G, Villavicencio MA, Smith MA, Kukreja J, Ardehali A, Hartwig M, Daneshmand MA, Hertz MI, Huddleston S, Haverich A, Madsen JC, Van Raemdonck D. Portable normothermic ex-vivo lung perfusion, ventilation, and functional assessment with the Organ Care System on donor lung use for transplantation from extended-criteria donors (EXPAND): a single-arm, pivotal trial. Lancet Respir Med. 2019 Nov;7(11):975-984. doi: 10.1016/S2213-2600(19)30200-0. Epub 2019 Aug 1.
PubMed 31378427
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Lung For Recruiting, Preserving and Assessing Expanded Criteria Donor Lungs for Transplantation (EXPAND Trial)
- ClinicalTrials.gov ID
- NCT01963780
- Acronym / sponsor ID
- EXPANDLung / OCS-LUN-012013
- Conditions
- Lung Transplant
- Keywords
- lung transplantation, lung preservation, breathing lung transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- TransMedicsIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- 22 Nov 2016 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 16 Oct 2013 (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.
To evaluate the safety and effectiveness of the OCS™ Lung to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.
Detailed description
The OCS™ Lung is to be used to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria from one or more of the following characteristics:
- Donor PaO2/FiO2 ≤ 300 mmHg; or
- Expected ischemic time > 6 hours; or
- Donor after Cardiac Death (DCD donor); or
- Donor age ≥55 years old
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCS Lung Tx. | Experimental | Device: OCS Lung PreservationA prospective, pivotal single arm trial. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least one of the following:
Key exclusion criteria (6 listed)
- • Presence of moderate to severe traumatic lung injury with air and/or blood leak
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 Lung Preservation | Device | OCS Lung Tx. |
Primary outcome
Number of Participants With Composite Endpoint of Patient Survival at Day-30 Post Transplant and Absence of Primary Graft Dysfunction (PGD) Grade 3 During the First 72 Hours Post Lung Transplant
Time frame: 30 days post lung 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.
2 secondary outcomes
Number of Participants With ISHLT Primary Graft Dysfunction (PGD) Grade 2 or 3 at T72 Hours Post Lung Transplantation
Time frame: 72 hours post lung transplantation
Number of Participants With Primary Graft Dysfunction Grade 3 at T72 Hours
Time frame: 72 hours post lung transplantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31378427Loor G, Warnecke G, Villavicencio MA, Smith MA, Kukreja J, Ardehali A, Hartwig M, Daneshmand MA, Hertz MI, Huddleston S, Haverich A, Madsen JC, Van Raemdonck D. Portable normothermic ex-vivo lung perfusion, ventilation, and functional assessment with the Organ Care System on donor lung use for transplantation from extended-criteria donors (EXPAND): a single-arm, pivotal trial. Lancet Respir Med. 2019 Nov;7(11):975-984. doi: 10.1016/S2213-2600(19)30200-0. Epub 2019 Aug 1.
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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 principal investigator
University of California, Los Angeles
Dirk Van Raemdonck, MD, PhD principal investigator
University of Leuven Medical Center
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCS Lung Preservation in people with Lung Transplant, run by TransMedics at 11 sites in 4 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 5 inclusion and 6 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 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Belgium, Germany, Spain. 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?
Number of Participants With Composite Endpoint of Patient Survival at Day-30 Post Transplant and Absence of Primary Graft Dysfunction (PGD) Grade 3 During the First 72 Hours Post Lung Transplant (time frame: 30 days post lung 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 NCT01963780, which also lists 1 linked publication.
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 7 Jul 2022.