Lung TransplantationNCT04616365
Planned Semi-Elective Lung Tx Study
A study testing Semi-Elective Lung Transplantation in people with Lung Transplantation, run by University Health Network, Toronto at 3 sites in 3 countries.
Trial summary
In the current practice of lung transplantation, transplants are performed on a 24/7 schedule with a significant amount of procedures occurring overnight in order to minimize organ ischemic time. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- Semi-Elective Lung Transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 26 Aug 2020to 21 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Recipient inclusion criteria
- Primary lung transplantation
- Informed consent provided
- 18-80 years old
Recipient exclusion criteria
- Re-transplantation
- Multi-organ transplantation
- >80 years old
Donor inclusion criteria
- Age ≤70 years old
- Donor lungs are suitable to go straight to lung transplantation
Donor exclusion criteria
- Age >70 years old
- Concerns with organ preservation technique
- Donor lungs require assessment by Ex Vivo Lung Perfusion (EVLP)
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Canada1 site
University Health Network (Toronto General Hospital)
Toronto, Ontario, M5G 2C4
About this study
Official title: Planned Semi-Elective Lung Transplantation Using 10°C Cold Static Preservation: A Proof-Of-Concept Study
In the current practice of lung transplantation, transplants are performed on a 24/7 schedule with a significant amount of procedures occurring overnight in order to minimize organ ischemic time. However, transplantation during the day time may lead to several advantages related to patient safety, including the presence of rested staff performing optimally, larger number of in-house professionals for emergency situations, and professional well-being. Advances and refinements in preservation practices have evolved to show that extended periods of preservation can be achieved without compromising outcome. Based on this, it is hypothesized that the avoidance of nighttime lung transplantation through prolonged pulmonary preservation will lead to at least similar patient outcomes compared to the current practice of 24/7 transplantation. During the period of this study, overnight transplants will be moved to a later start time (earliest 6AM). If lungs meet criteria for direct transplantation, they will be preserved with cold static preservation at 10°C within a special refrigerator. The maximum preservation time from donor cold flush to recipient anesthesia start time will be 12 hours.
- Conditions
- Lung Transplantation
- Being tested
- Semi-Elective Lung Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-Elective Lung TransplantationProcedure or surgery
When suitable donor lungs become available for a consented recipient, the transplant procedure (anesthesia starting time) will be allowed to begin earliest at 6am with the lungs being preserved at 10°C cold static preservation upon organ arrival to our hospital using a specific incubator, regardless of when donor cross clamp occurs. The maximum time allowed between donor cross clamp and recipient anesthesia initiation will be 12h.
| Study group | Role | What they receive |
|---|---|---|
| Semi-Elective Lung Transplantation | Experimental | Planned Semi-Elective Lung Transplantation Using 10°C Cold Static Preservation Receives: Procedure: Semi-Elective Lung Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ISHLT Primary Graft Dysfunction Grade 3
Measured: 72 hours post-transplant
Secondary outcomes (6)
Overall survival
Measured: 30 days, 1 year post-transplant
Time on ventilator
Measured: Perioperative
ICU and hospital length of stay
Measured: Perioperative
Occurrence of acute rejection
Measured: 1 year post-transplant
Six minute walk test
Measured: 1 year post-transplant
Forced expiratory volume - one second (FEV1 in L)
Measured: 1 year post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start26 Aug 2020
- Primary completion24 Apr 2022
- Study completion21 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcelo Cypel, MD MSc, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616365
- Sponsor's protocol ID
- 19-6364
- Status last verified
- Dec 2023
- First submitted
- 25 Aug 2020
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Iskender I. Technical Advances Targeting Multiday Preservation of Isolated Ex Vivo Lung Perfusion. Transplantation. 2024 Jun 1;108(6):1319-1332. doi: 10.1097/TP.0000000000004992. Epub 2024 May 23.
PubMed 38499501Ali A, Hoetzenecker K, Luis Campo-Canaveral de la Cruz J, Schwarz S, Barturen MG, Tomlinson G, Yeung J, Donahoe L, Yasufuku K, Pierre A, de Perrot M, Waddell TK, Keshavjee S, Cypel M. Extension of Cold Static Donor Lung Preservation at 10 degrees C. NEJM Evid. 2023 Jun;2(6):EVIDoa2300008. doi: 10.1056/EVIDoa2300008. Epub 2023 Apr 20.
PubMed 38320127
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Planned Semi-Elective Lung Transplantation Using 10°C Cold Static Preservation: A Proof-Of-Concept Study
- ClinicalTrials.gov ID
- NCT04616365
- Acronym / sponsor ID
- 19-6364
- Conditions
- Lung Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 24 Apr 2022 (actual)
- Study completion
- 21 Apr 2023 (actual)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the current practice of lung transplantation, transplants are performed on a 24/7 schedule with a significant amount of procedures occurring overnight in order to minimize organ ischemic time. However, transplantation during the day time may lead to several advantages related to patient safety, including the presence of rested staff performing optimally, larger number of in-house professionals for emergency situations, and professional well-being. Advances and refinements in preservation practices have evolved to show that extended periods of preservation can be achieved without compromising outcome. Based on this, it is hypothesized that the avoidance of nighttime lung transplantation through prolonged pulmonary preservation will lead to at least similar patient outcomes compared to the current practice of 24/7 transplantation. During the period of this study, overnight transplants will be moved to a later start time (earliest 6AM). If lungs meet criteria for direct transplantation, they will be preserved with cold static preservation at 10°C within a special refrigerator. The maximum preservation time from donor cold flush to recipient anesthesia start time will be 12 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Semi-Elective Lung Transplantation | Experimental | Procedure: Semi-Elective Lung TransplantationPlanned Semi-Elective Lung Transplantation Using 10°C Cold Static Preservation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Semi-Elective Lung TransplantationWhen suitable donor lungs become available for a consented recipient, the transplant procedure (anesthesia starting time) will be allowed to begin earliest at 6am with the lungs being preserved at 10°C cold static preservation upon organ arrival to our hospital using a specific incubator, regardless of when donor cross clamp occurs. The maximum time allowed between donor cross clamp and recipient anesthesia initiation will be 12h. | Procedure or surgery | Semi-Elective Lung Transplantation |
Primary outcome
Incidence of ISHLT Primary Graft Dysfunction Grade 3
Time frame: 72 hours post-transplant
6 secondary outcomes
Overall survival
Time frame: 30 days, 1 year post-transplant
Time on ventilator
Time frame: Perioperative
ICU and hospital length of stay
Time frame: Perioperative
Occurrence of acute rejection
Time frame: 1 year post-transplant
Six minute walk test
Time frame: 1 year post-transplant
Forced expiratory volume - one second (FEV1 in L)
Time frame: 1 year post-transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Derived from this study: PubMed 38499501Iskender I. Technical Advances Targeting Multiday Preservation of Isolated Ex Vivo Lung Perfusion. Transplantation. 2024 Jun 1;108(6):1319-1332. doi: 10.1097/TP.0000000000004992. Epub 2024 May 23.
- Derived from this study: PubMed 38320127Ali A, Hoetzenecker K, Luis Campo-Canaveral de la Cruz J, Schwarz S, Barturen MG, Tomlinson G, Yeung J, Donahoe L, Yasufuku K, Pierre A, de Perrot M, Waddell TK, Keshavjee S, Cypel M. Extension of Cold Static Donor Lung Preservation at 10 degrees C. NEJM Evid. 2023 Jun;2(6):EVIDoa2300008. doi: 10.1056/EVIDoa2300008. Epub 2023 Apr 20.
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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.
Marcelo Cypel, MD MSc principal investigator
University Health Network, Toronto
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semi-Elective Lung Transplantation in people with Lung Transplantation, run by University Health Network, Toronto at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria, Canada, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of ISHLT Primary Graft Dysfunction Grade 3 (time frame: 72 hours post-transplant). 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 NCT04616365, 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 28 Dec 2023.