Lung TransplantEVLP-CHUMNCT02235610
Use of Ex Vivo Lung Perfusion (EVLP) in Reconditioning Marginal Donor Lungs for Transplantation
A study testing EVLP Group in people with Lung Transplant, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The overall objective of this study is to evaluate the clinical effectiveness of the novel technique of donor EVLP in increasing lung transplant activity by allowing previously unusable donor lungs to be safely used in clinical lung transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lung Transplant
- What is being tested?
- EVLP Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Dec 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (aged 18 years and over).
- Patients already on or added to the active waiting list for first lung transplant.
- Patients providing informed consent for participation in the study at the time of study commencement or time of listing for transplant.
- Patients' re-confirmation informed consent for the study on the day of the lung transplant.
Who cannot join
- Patients aged less than 18 years.
- Patients not providing informed consent for the study.
- Patients not in possession of patient information sheets for the study prior to the day of lung transplant.
- Patients' not re-confirming consent for the study on the day of lung transplant.
- Patients requiring invasive mechanical ventilation, extracorporeal membrane oxygenation (ECMO) support.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
Ahmed Menaouar, PhD, 514-890-8000 ext. 30785, ahmed.menaouar.chum@ssss.gouv.qc.ca
Basil Nasir, MD, 514-890-8000 ext. 26275, basilsnasir@gmail.com
About this study
Official title: Clinical Trial of Ex Vivo Lung Perfusion (EVLP) for the Reconditioning of Marginal Donor Lungs for Transplantation.
The overall objective of this study is to evaluate the clinical effectiveness of the novel technique of donor EVLP in increasing lung transplant activity by allowing previously unusable donor lungs to be safely used in clinical lung transplantation. Furthermore, to utilize the EVLP technique in research settings thus allowing the evaluation of inflammatory molecules (biomarkers) that would benefit a successful pre-conditioning and increase knowledge of the lungs inflammatory response before transplantation.
Read the detailed description
Human donor lungs that do not meet the standard clinical criteria for donor lung utilization but fit into the study inclusion criteria will be retrieved from the donor using current donor lung retrieval techniques. These lungs will be brought to the study transplant centre to be perfused in our system by the transplant team. Perfusion of these lungs will be performed using evaluation solution with addition of red blood cells cross matched with the recipient, heparin and antibiotics. Those lungs that after perfusion in our system meet the normal transplantation criteria will be considered for transplantation. Lungs will be excluded for transplantation if the organs don't meet the normal transplantation criteria.
- Conditions
- Lung Transplant
- Being tested
- EVLP Group
- Keywords
- Lung Transplantation, Ex Vivo Lung Perfusion, EVLP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVLP GroupProcedure or surgery
EVLP technique (Lund Protocol): open left atrium, Steen solution mixed with red blood cells and perfusion 100% of the donor predicted cardiac output.
Lungs with good and stable function during EVLP will be transplanted into recipients as per current clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Standard Group | No intervention | Recipients receive standard donor lungs as per current clinical practice. No experimental procedures will be carried out. |
| EVLP Group | Experimental | Recipients receive reconditioned EVLP donor lungs and current standard of care for lung transplant is administered. Receives: Procedure: EVLP Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of survival
To measure survival 12 months after transplantation in recipients of EVLP assessed and reconditioned donor lungs (treatment group), compared to that of recipients of standard donor lungs (control group), in order to assess whether survival in the EVLP treatment group over that period is non-inferior to that in the standard control group
Measured: 12 months after transplantation
Secondary outcomes (5)
Evaluate primary graft dysfunction (PGD)
PGD is a clinical entity that reflects the development of early acute lung injury after lung transplantation. PGD severity is graded between 0 and 3 and it is measured at 6h, 12h, 24h, 48h and 72 hours after lung transplantation
Measured: 6h, 12h, 24h, 48h and 72h post-transplant
Duration of hospital stay
Participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Measured: Expected average of 6 weeks
Duration of mechanical ventilation
How long it takes to disconnect the patient from mechanical ventilation
Measured: 30 days after lung transplant
Quality of life (QoL) questionnaire
Questions about Health and Well-Being of patient after lung transplantation
Measured: The day that patients are added to transplant list, at 90 days and 1 year post transplantation
90 day Mortality
Patient survival 90 days after lung transplantation
Measured: 90 days after lung transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Pour La Recherche en Chirurgie Thoracique De Montreal, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Institut de Recherches Cliniques de Montreal
- Responsible party
- Sponsor
- Investigators
- Pasquale Ferraro, MD, Principal investigator, CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235610
- Sponsor's protocol ID
- CE14.100
- Acronym
- EVLP-CHUM
- Status last verified
- Dec 2023
- First submitted
- 25 Aug 2014
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Ex Vivo Lung Perfusion (EVLP) for the Reconditioning of Marginal Donor Lungs for Transplantation.
- ClinicalTrials.gov ID
- NCT02235610
- Acronym / sponsor ID
- EVLP-CHUM / CE14.100
- Conditions
- Lung Transplant
- Keywords
- Lung Transplantation, Ex Vivo Lung Perfusion, EVLP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Fondation Pour La Recherche en Chirurgie Thoracique De Montreal, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Institut de Recherches Cliniques de Montreal
- Study start
- Oct 2014 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 10 Sep 2014 (estimated)
- 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.
The overall objective of this study is to evaluate the clinical effectiveness of the novel technique of donor EVLP in increasing lung transplant activity by allowing previously unusable donor lungs to be safely used in clinical lung transplantation. Furthermore, to utilize the EVLP technique in research settings thus allowing the evaluation of inflammatory molecules (biomarkers) that would benefit a successful pre-conditioning and increase knowledge of the lungs inflammatory response before transplantation.
Detailed description
Human donor lungs that do not meet the standard clinical criteria for donor lung utilization but fit into the study inclusion criteria will be retrieved from the donor using current donor lung retrieval techniques. These lungs will be brought to the study transplant centre to be perfused in our system by the transplant team. Perfusion of these lungs will be performed using evaluation solution with addition of red blood cells cross matched with the recipient, heparin and antibiotics. Those lungs that after perfusion in our system meet the normal transplantation criteria will be considered for transplantation. Lungs will be excluded for transplantation if the organs don't meet the normal transplantation criteria.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Group | No intervention | –Recipients receive standard donor lungs as per current clinical practice. No experimental procedures will be carried out. |
| EVLP Group | Experimental | Procedure: EVLP GroupRecipients receive reconditioned EVLP donor lungs and current standard of care for lung transplant is administered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (aged 18 years and over).
- Patients already on or added to the active waiting list for first lung transplant.
- Patients providing informed consent for participation in the study at the time of study commencement or time of listing for transplant.
- Patients' re-confirmation informed consent for the study on the day of the lung transplant.
Key exclusion criteria (5 listed)
- Patients aged less than 18 years.
- Patients not providing informed consent for the study.
- Patients not in possession of patient information sheets for the study prior to the day of lung transplant.
- Patients' not re-confirming consent for the study on the day of lung transplant.
- Patients requiring invasive mechanical ventilation, extracorporeal membrane oxygenation (ECMO) support.
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 |
|---|---|---|
| EVLP GroupEVLP technique (Lund Protocol): open left atrium, Steen solution mixed with red blood cells and perfusion 100% of the donor predicted cardiac output. Lungs with good and stable function during EVLP will be transplanted into recipients as per current clinical practice. | Procedure or surgery | EVLP Group |
Primary outcome
Measure of survival
Time frame: 12 months after transplantation
To measure survival 12 months after transplantation in recipients of EVLP assessed and reconditioned donor lungs (treatment group), compared to that of recipients of standard donor lungs (control group), in order to assess whether survival in the EVLP treatment group over that period is non-inferior to that in the standard control group
5 secondary outcomes
Evaluate primary graft dysfunction (PGD)
Time frame: 6h, 12h, 24h, 48h and 72h post-transplant
Duration of hospital stay
Time frame: Expected average of 6 weeks
Duration of mechanical ventilation
Time frame: 30 days after lung transplant
Quality of life (QoL) questionnaire
Time frame: The day that patients are added to transplant list, at 90 days and 1 year post transplantation
90 day Mortality
Time frame: 90 days after lung transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
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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.
Pasquale Ferraro, MD principal investigator
CHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVLP Group in people with Lung Transplant, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 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 1 site in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Menaouar, PhD (514-890-8000 ext. 30785, ahmed.menaouar.chum@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of survival (time frame: 12 months after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2023.