Ex Vivo Lung PerfusionNCT03053349
Ex Vivo Lung Perfusion in Bergamo Lung Transplant Program
An observational study of Ex Vivo Lung Perfusion and Lung Transplantation, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
Trial summary
Ex Vivo Lung Perfusion (EVLP) appears to be an effective strategy to expand the lung donor pool by better evaluation and reconditioning of non standard grafts. Today, EVLP is clinical practice at the most active transplant centers in North America and Europe. Read more about this study
- Who is it for?
- Ages 1 month to 70 years
- Conditions the study is for
- Ex Vivo Lung Perfusion, Lung Transplantation
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 12 Apr 2017to 6 Dec 2020
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 1 month to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the patients on the waiting list for monolateral or bilateral lung transplantation at Bergamo lung transplant center
Recipients' Inclusion Criteria:
- lung transplant candidates who are going to be transplanted with grafts subjected to EVLP
- lung transplant candidates who consent to participate in the study by signing the informed consent form.
Recipients' Exclusion Criteria:
- lung transplant candidates who are going to be transplanted with grafts not subjected to EVLP
- lung transplant candidates who are going to be transplanted with grafts subjected to EVLP but refuse consent for their participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ex Vivo Lung Perfusion in Bergamo Lung Transplant Program: A Prospective Observational Study
Ex Vivo Lung Perfusion (EVLP) appears to be an effective strategy to expand the lung donor pool by better evaluation and reconditioning of non standard grafts. Today, EVLP is clinical practice at the most active transplant centers in North America and Europe.
The aim of this observational prospective monocentric study is to prove the safety and efficacy of EVLP performed in the setting of Bergamo lung transplant program.
Read more
A statistically estimated sample size would not fit with the small numbers of Italian lung transplant activity, so the investigators decided to enrol 10 consecutive recipients of grafts subjected to EVLP.
Non standard grafts from Brain Dead Donors (BDD) and Donors after Cardiac Death (DCD) and standard grafts that will undergo prolonged cold ischemic time will be selected for EVLP.
The donor lung procurement operation will be done in the usual manner. The EVLP procedure will be performed in the operating theater of Papa Giovanni XXIII Hospital. The investigators decided to adopt Toronto protocol since it involves some lung protective strategies. EVLP will proceed over a period of at least 4 and not more than 6 hours.
After 60, 120, 180 and 240 minutes from the start of EVLP the following parameters will be evaluated:
- ratio of the partial pressure of arterial oxygen to fraction of inspired oxygen (PO2/FiO2, mmHg)
- Pulmonary Vascular Resistance (PVR, dine*s/cm5)
- Peak Inspiratory Pressure (PIP, cmH2O) and mean airways Pressure (Pawm, cmH2O)
- dynamic lung Compliance (Cpldyn, ml/ cmH2O)
- ΔPO2 = pulmonary vein PO2 - pulmonary artery PO2 (mmHg). Moreover, after 60 and 240 minutes from the start of EVLP a graft X-ray and a bronchoscopy will be performed.
The lung graft will be accepted for transplantation if, after 240 minutes from the start of EVLP, the following conditions are fulfilled:
- PO2/FiO2 >350 mmHg
- stability or reduction of PVR compared with the measurement at the baseline assessment time point
- stability or reduction of PIP and Pawm compared with the measurement at the baseline assessment time point
- stable or better Cpldyn compared with the measurement at the baseline assessment time point
- ΔPO2 >400 mmHg
- improvement of X-ray imaging compared with that at the baseline assessment time point
- exclusion of oedema and purulent secretions by bronchoscopy. After transplantation the recipients will be followed-up for 1 year according to a scheduled timetable.
Data about the EVLP and transplant procedure and about the characteristics of donors and recipients will be collected in a dedicated electronic Case report form (eCRF) according to Good Clinical Practice.
Read the detailed description
Ex Vivo Lung Perfusion (EVLP) has been allowing to expand the lung donor pool by better evaluation and reconditioning of non standard grafts. The results of both completed and still recruiting prospective clinical trials show similar short- and long-term post-transplant outcomes with non standard and standard grafts subjected to EVLP and traditionally preserved standard grafts. Today, EVLP is clinical practice at the most active transplant centers in North America and Europe.
The aim of this observational prospective monocentric study is to prove the safety and efficacy of EVLP performed in the setting of Bergamo lung transplant program.
A statistically estimated sample size would not fit with the small numbers of Italian lung transplant activity, so the investigators decided to enrol 10 consecutive recipients of grafts subjected to EVLP.
Non standard grafts from Brain Dead Donors (BDD) and Donors after Cardiac Death (DCD) and standard grafts that will undergo prolonged cold ischemic time will be selected for EVLP. Grafts from donors over the age of 65 and/or with a smocking history of more than 10 pack-year and/or with chronic lung disease and/or with gross gastric aspiration and/or with a diagnosis of established pneumonia will be rejected.
The donor lung procurement operation will be done in the usual manner. After excision, the right and left graft will not be divided and will be packed in ice for transportation.
The EVLP procedure will be performed in the operating theater of Papa Giovanni XXIII Hospital. The investigators decided to adopt Toronto protocol since it involves some lung protective strategies. EVLP will proceed over a period of at least 4 and not more than 6 hours.
After 60, 120, 180 and 240 minutes from the start of EVLP the following parameters will be evaluated:
- PO2/FiO2 (mmHg)
- Pulmonary Vascular Resistance (PVR, dine*s/cm5)
- Peak Inspiratory Pressure (PIP, cmH2O) and mean airways Pressure (Pawm, cmH2O)
- dynamic lung Compliance (Cpldyn, ml/ cmH2O)
- ΔPO2 = pulmonary vein PO2 - pulmonary artery PO2 (mmHg). Moreover, after 60 and 240 minutes from the start of EVLP a graft X-ray and a bronchoscopy will be performed.
The lung graft will be accepted for transplantation if, after 240 minutes from the start of EVLP, the following conditions are fulfilled:
- PO2/FiO2 >350 mmHg
- stability or reduction of PVR compared with the measurement at the baseline assessment time point
- stability or reduction of PIP and Pawm compared with the measurement at the baseline assessment time point
- stable or better Cpldyn compared with the measurement at the baseline assessment time point
- ΔPO2 >400 mmHg
- improvement of X-ray imaging compared with that at the baseline assessment time point
- exclusion of oedema and purulent secretions by bronchoscopy. If the lung graft is considered suitable for transplantation, the EVLP procedure will be stopped as described by Toronto protocol and the right and left graft will be divided and packed for hypothermic preservation until implantation.
After transplantation the recipients will be followed-up for 1 year according to a scheduled timetable.
Data about the EVLP and transplant procedure and about the characteristics of donors and recipients will be collected in a dedicated electronic Case Report Form (eCRF) according to Good Clinical Practice.
- Conditions
- Ex Vivo Lung Perfusion, Lung Transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade of Primary Graft Dysfunction (PGD)
Classification scheme proposed by the International Society for Heart and Lung Transplantation (ISHLT)
Measured: 72 hours after transplantation
Secondary outcomes (7)
Grade of PGD
Classification scheme proposed by the ISHLT
Measured: 24 and 48 hours after transplantation
Need for ECMO
Use of post-operative ECMO to support lung and/or heart function (yes/no)
Measured: 1 year after transplantation
Length of ICU and hospital stay
Length of ICU and hospital stay after transplantation (days)
Measured: 1 year after transplantation
Duration of mechanical ventilation
Duration of mechanical ventilation after transplantation (days)
Measured: 1 year after transplantation
Incidence of anastomotic airway complications
MDS endoscopic standardized grading system for macroscopic central airway complications after lung transplantation
Measured: Up to 12 months after transplantation
30-day mortality
Mortality rate 30 days after transplantation
Measured: 30 days after transplantation
1-year patient survival
Patient survival rate 1 year after transplantation
Measured: 1 year after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start12 Apr 2017
- Primary completion6 Dec 2020
- Study completion6 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ex Vivo Lung PerfusionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Papa Giovanni XXIII Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefania Camagni, Papa Giovanni XXIII Hospital
- Investigators
- Stefania Camagni, MD, Principal investigator, Papa Giovanni XXIII HospitalMichele Colledan, MD, Study director, Papa Giovanni XXIII Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053349
- Sponsor's protocol ID
- EVLP Bergamo - nr 2016-0194
- Status last verified
- May 2023
- First submitted
- 9 Feb 2017
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex Vivo Lung Perfusion in Bergamo Lung Transplant Program: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03053349
- Acronym / sponsor ID
- EVLP Bergamo - nr 2016-0194
- Conditions
- Ex Vivo Lung Perfusion, Lung Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Papa Giovanni XXIII HospitalUniversity, hospital or other
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 6 Dec 2020 (actual)
- Study completion
- 6 Dec 2020 (actual)
- First posted
- 15 Feb 2017 (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.
Ex Vivo Lung Perfusion (EVLP) appears to be an effective strategy to expand the lung donor pool by better evaluation and reconditioning of non standard grafts. Today, EVLP is clinical practice at the most active transplant centers in North America and Europe.
The aim of this observational prospective monocentric study is to prove the safety and efficacy of EVLP performed in the setting of Bergamo lung transplant program.
A statistically estimated sample size would not fit with the small numbers of Italian lung transplant activity, so the investigators decided to enrol 10 consecutive recipients of grafts subjected to EVLP.
Non standard grafts from Brain Dead Donors (BDD) and Donors after Cardiac Death (DCD) and standard grafts that will undergo prolonged cold ischemic time will be selected for EVLP.
The donor lung procurement operation will be done in the usual manner. The EVLP procedure will be performed in the operating theater of Papa Giovanni XXIII Hospital. The investigators decided to adopt Toronto protocol since it involves some lung protective strategies. EVLP will proceed over a period of at least 4 and not more than 6 hours.
After 60, 120, 180 and 240 minutes from the start of EVLP the following parameters will be evaluated:
- ratio of the partial pressure of arterial oxygen to fraction of inspired oxygen (PO2/FiO2, mmHg)
- Pulmonary Vascular Resistance (PVR, dine*s/cm5)
- Peak Inspiratory Pressure (PIP, cmH2O) and mean airways Pressure (Pawm, cmH2O)
- dynamic lung Compliance (Cpldyn, ml/ cmH2O)
- ΔPO2 = pulmonary vein PO2 - pulmonary artery PO2 (mmHg). Moreover, after 60 and 240 minutes from the start of EVLP a graft X-ray and a bronchoscopy will be performed.
The lung graft will be accepted for transplantation if, after 240 minutes from the start of EVLP, the following conditions are fulfilled:
- PO2/FiO2 >350 mmHg
- stability or reduction of PVR compared with the measurement at the baseline assessment time point
- stability or reduction of PIP and Pawm compared with the measurement at the baseline assessment time point
- stable or better Cpldyn compared with the measurement at the baseline assessment time point
- ΔPO2 >400 mmHg
- improvement of X-ray imaging compared with that at the baseline assessment time point
- exclusion of oedema and purulent secretions by bronchoscopy. After transplantation the recipients will be followed-up for 1 year according to a scheduled timetable.
Data about the EVLP and transplant procedure and about the characteristics of donors and recipients will be collected in a dedicated electronic Case report form (eCRF) according to Good Clinical Practice.
Detailed description
Ex Vivo Lung Perfusion (EVLP) has been allowing to expand the lung donor pool by better evaluation and reconditioning of non standard grafts. The results of both completed and still recruiting prospective clinical trials show similar short- and long-term post-transplant outcomes with non standard and standard grafts subjected to EVLP and traditionally preserved standard grafts. Today, EVLP is clinical practice at the most active transplant centers in North America and Europe.
The aim of this observational prospective monocentric study is to prove the safety and efficacy of EVLP performed in the setting of Bergamo lung transplant program.
A statistically estimated sample size would not fit with the small numbers of Italian lung transplant activity, so the investigators decided to enrol 10 consecutive recipients of grafts subjected to EVLP.
Non standard grafts from Brain Dead Donors (BDD) and Donors after Cardiac Death (DCD) and standard grafts that will undergo prolonged cold ischemic time will be selected for EVLP. Grafts from donors over the age of 65 and/or with a smocking history of more than 10 pack-year and/or with chronic lung disease and/or with gross gastric aspiration and/or with a diagnosis of established pneumonia will be rejected.
The donor lung procurement operation will be done in the usual manner. After excision, the right and left graft will not be divided and will be packed in ice for transportation.
The EVLP procedure will be performed in the operating theater of Papa Giovanni XXIII Hospital. The investigators decided to adopt Toronto protocol since it involves some lung protective strategies. EVLP will proceed over a period of at least 4 and not more than 6 hours.
After 60, 120, 180 and 240 minutes from the start of EVLP the following parameters will be evaluated:
- PO2/FiO2 (mmHg)
- Pulmonary Vascular Resistance (PVR, dine*s/cm5)
- Peak Inspiratory Pressure (PIP, cmH2O) and mean airways Pressure (Pawm, cmH2O)
- dynamic lung Compliance (Cpldyn, ml/ cmH2O)
- ΔPO2 = pulmonary vein PO2 - pulmonary artery PO2 (mmHg). Moreover, after 60 and 240 minutes from the start of EVLP a graft X-ray and a bronchoscopy will be performed.
The lung graft will be accepted for transplantation if, after 240 minutes from the start of EVLP, the following conditions are fulfilled:
- PO2/FiO2 >350 mmHg
- stability or reduction of PVR compared with the measurement at the baseline assessment time point
- stability or reduction of PIP and Pawm compared with the measurement at the baseline assessment time point
- stable or better Cpldyn compared with the measurement at the baseline assessment time point
- ΔPO2 >400 mmHg
- improvement of X-ray imaging compared with that at the baseline assessment time point
- exclusion of oedema and purulent secretions by bronchoscopy. If the lung graft is considered suitable for transplantation, the EVLP procedure will be stopped as described by Toronto protocol and the right and left graft will be divided and packed for hypothermic preservation until implantation.
After transplantation the recipients will be followed-up for 1 year according to a scheduled timetable.
Data about the EVLP and transplant procedure and about the characteristics of donors and recipients will be collected in a dedicated electronic Case Report Form (eCRF) according to Good Clinical Practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 1 month to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patients on the waiting list for monolateral or bilateral lung transplantation at Bergamo lung transplant center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Grade of Primary Graft Dysfunction (PGD)
Time frame: 72 hours after transplantation
Classification scheme proposed by the International Society for Heart and Lung Transplantation (ISHLT)
7 secondary outcomes
Grade of PGD
Time frame: 24 and 48 hours after transplantation
Need for ECMO
Time frame: 1 year after transplantation
Length of ICU and hospital stay
Time frame: 1 year after transplantation
Duration of mechanical ventilation
Time frame: 1 year after transplantation
Incidence of anastomotic airway complications
Time frame: Up to 12 months after transplantation
30-day mortality
Time frame: 30 days after transplantation
1-year patient survival
Time frame: 1 year after transplantation
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 23 May 2023.
- Individual participant dataSharing planned: No
Related trials for Ex Vivo Lung Perfusion
Active, not recruitingObservational study
An All Comers Registry For Normothermic Ex Vivo Lung Perfusion (EVLP) as Assessment of Donor Lungs for Transplant
Lung Transplant
Not yet recruiting
Comparison Between Two Medical Devices for the Reconditioning of Lungs Intended for Transplantation
Lung Transplant Surgery
Recruiting
Evaluating the Addition of Hemodiafiltration to EVLP - Impact on the Regeneration of Marginal Donor Lungs
Lung Diseases
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.
Stefania Camagni, MD principal investigator
Papa Giovanni XXIII Hospital
Michele Colledan, MD study director
Papa Giovanni XXIII Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ex Vivo Lung Perfusion and Lung Transplantation, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
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 23 May 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 Italy. 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?
Grade of Primary Graft Dysfunction (PGD) (time frame: 72 hours 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 23 May 2023.