Disorder Related to Lung TransplantationPhase 1EVLP_MINCT01967953
Ex-Vivo Lung Perfusion to Increase the Number of Organs for Transplantation
A Phase 1 study testing EVLP Group in people with Disorder Related to Lung Transplantation and Brain Death, run by Policlinico Hospital at 1 site in Italy.
Trial summary
The recent introduction of ex-vivo lung perfusion (EVLP) as a tool to evaluate and recondition lungs from marginal donors has opened a new era in the field of lung transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorder Related to Lung Transplantation, Brain Death, Graft Failure
- 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
- 7 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2011to May 2013
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipient to undergo single or bilateral Lung Transplantation
- Donor arterial partial pressure of oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) below 300 mmHg, or doubtful donor lung function
Who cannot join
- Massive lung contusion
- Aspiration
- Pneumonia
- Sepsis
- Malignancy
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Ca' Granda IRCCS Ospedale Maggiore Policlinico
Milan, Italy, 20122
About this study
Official title: Ex-Vivo Lung Perfusion to Improve Donor Lung Function and Increase the Number of Organs Available for Transplantation
The recent introduction of ex-vivo lung perfusion (EVLP) as a tool to evaluate and recondition lungs from marginal donors has opened a new era in the field of lung transplantation.
Read the detailed description
Aim of the investigation: to compare the clinical outcome after transplantation of subjects receiving marginal lungs procured from brain death donors and reconditioned by EVLP, with that of subjects receiving lungs procured from standard donors.
- Conditions
- Disorder Related to Lung Transplantation, Brain Death, Graft Failure, Primary Graft Dysfunction
- Being tested
- EVLP Group
- Medical subject headings
- Brain Death, Primary Graft Dysfunction
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: Steen solution; normothermia; low flow, open atrium, low hematocrit.
Endpoints of EVLP assessment of lungs suitability: oxygenation, respiratory mechanics, pulmonary vascular resistance, chest X-ray, fibrobronchoscopy
| Study group | Role | What they receive |
|---|---|---|
| Standard Group | No intervention | Recipients of lungs procured from brain death donors deemed suitable for transplantation according to standard criteria. Events: lung procurement, cold storage on ice, transplantation. |
| EVLP Group | Experimental | Recipients of marginal lungs procured from brain death donors and reconditioned with ex-vivo lung perfusion (EVLP).
Events: lung procurement, cold storage on ice, reconditioning by EVLP, cold storage on ice, transplantation. Receives: Procedure: EVLP Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Graft Dysfunction 72 hours after lung transplantation (PGD72)
Primary Graft Dysfunction 72 hours after transplantation (PGD72) definition: grade 3 according to the International Society of Heart and Lung Transplantation classification
Measured: 72 hours
30 day Mortality
Measured: 30 days
Secondary outcomes (2)
Duration of mechanical ventilation after transplantation
Measured: 30 days
ICU length of stay after transplantation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study startJan 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Disorder Related to Lung TransplantationStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franco Valenza, MD, Policlinico Hospital
- Investigators
- Franco Valenza, MD, Principal investigator, Fondazione Ca' Granda IRCCS Ospedale Maggiore Policlinico Milan Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967953
- Sponsor's protocol ID
- EVLP_2011
- Acronym
- EVLP_MI
- Status last verified
- Oct 2013
- First submitted
- 17 Oct 2013
- Last updated
- 23 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cypel M, Yeung JC, Liu M, Anraku M, Chen F, Karolak W, Sato M, Laratta J, Azad S, Madonik M, Chow CW, Chaparro C, Hutcheon M, Singer LG, Slutsky AS, Yasufuku K, de Perrot M, Pierre AF, Waddell TK, Keshavjee S. Normothermic ex vivo lung perfusion in clinical lung transplantation. N Engl J Med. 2011 Apr 14;364(15):1431-40. doi: 10.1056/NEJMoa1014597.
PubMed 21488765Oto T, Levvey BJ, Whitford H, Griffiths AP, Kotsimbos T, Williams TJ, Snell GI. Feasibility and utility of a lung donor score: correlation with early post-transplant outcomes. Ann Thorac Surg. 2007 Jan;83(1):257-63. doi: 10.1016/j.athoracsur.2006.07.040.
PubMed 17184674Aigner C, Winkler G, Jaksch P, Seebacher G, Lang G, Taghavi S, Wisser W, Klepetko W. Extended donor criteria for lung transplantation--a clinical reality. Eur J Cardiothorac Surg. 2005 May;27(5):757-61. doi: 10.1016/j.ejcts.2005.01.024.
PubMed 15848310Steen S, Ingemansson R, Eriksson L, Pierre L, Algotsson L, Wierup P, Liao Q, Eyjolfsson A, Gustafsson R, Sjoberg T. First human transplantation of a nonacceptable donor lung after reconditioning ex vivo. Ann Thorac Surg. 2007 Jun;83(6):2191-4. doi: 10.1016/j.athoracsur.2007.01.033.
PubMed 17532422Valenza F, Rosso L, Coppola S, Froio S, Colombo J, Dossi R, Fumagalli J, Salice V, Pizzocri M, Conte G, Gatti S, Santambrogio L, Gattinoni L. beta-adrenergic agonist infusion during extracorporeal lung perfusion: effects on glucose concentration in the perfusion fluid and on lung function. J Heart Lung Transplant. 2012 May;31(5):524-30. doi: 10.1016/j.healun.2012.02.001. Epub 2012 Mar 3.
PubMed 22386450Botha P, Trivedi D, Weir CJ, Searl CP, Corris PA, Dark JH, Schueler SV. Extended donor criteria in lung transplantation: impact on organ allocation. J Thorac Cardiovasc Surg. 2006 May;131(5):1154-60. doi: 10.1016/j.jtcvs.2005.12.037.
PubMed 16678604Valenza F, Rosso L, Pizzocri M, Salice V, Umbrello M, Conte G, Stanzi A, Colombo J, Gatti S, Santambrogio L, Iapichino G, Gattinoni L. The consumption of glucose during ex vivo lung perfusion correlates with lung edema. Transplant Proc. 2011 May;43(4):993-6. doi: 10.1016/j.transproceed.2011.01.122.
PubMed 21620034Valenza F, Rosso L, Coppola S, Froio S, Palleschi A, Tosi D, Mendogni P, Salice V, Ruggeri GM, Fumagalli J, Villa A, Nosotti M, Santambrogio L, Gattinoni L. Ex vivo lung perfusion to improve donor lung function and increase the number of organs available for transplantation. Transpl Int. 2014 Jun;27(6):553-61. doi: 10.1111/tri.12295. Epub 2014 Apr 4.
PubMed 24628890
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex-Vivo Lung Perfusion to Improve Donor Lung Function and Increase the Number of Organs Available for Transplantation
- ClinicalTrials.gov ID
- NCT01967953
- Acronym / sponsor ID
- EVLP_MI / EVLP_2011
- Conditions
- Disorder Related to Lung Transplantation, Brain Death, Graft Failure, Primary Graft Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 23 Oct 2013 (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 recent introduction of ex-vivo lung perfusion (EVLP) as a tool to evaluate and recondition lungs from marginal donors has opened a new era in the field of lung transplantation.
Detailed description
Aim of the investigation: to compare the clinical outcome after transplantation of subjects receiving marginal lungs procured from brain death donors and reconditioned by EVLP, with that of subjects receiving lungs procured from standard donors.
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 of lungs procured from brain death donors deemed suitable for transplantation according to standard criteria. Events: lung procurement, cold storage on ice, transplantation. |
| EVLP Group | Experimental | Procedure: EVLP GroupRecipients of marginal lungs procured from brain death donors and reconditioned with ex-vivo lung perfusion (EVLP). Events: lung procurement, cold storage on ice, reconditioning by EVLP, cold storage on ice, transplantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Recipient to undergo single or bilateral Lung Transplantation
- Donor arterial partial pressure of oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) below 300 mmHg, or doubtful donor lung function
Key exclusion criteria (5 listed)
- Massive lung contusion
- Aspiration
- Pneumonia
- Sepsis
- Malignancy
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: Steen solution; normothermia; low flow, open atrium, low hematocrit. Endpoints of EVLP assessment of lungs suitability: oxygenation, respiratory mechanics, pulmonary vascular resistance, chest X-ray, fibrobronchoscopy | Procedure or surgery | EVLP Group |
Primary outcome
Primary Graft Dysfunction 72 hours after lung transplantation (PGD72)
Time frame: 72 hours
Primary Graft Dysfunction 72 hours after transplantation (PGD72) definition: grade 3 according to the International Society of Heart and Lung Transplantation classification
30 day Mortality
Time frame: 30 days
2 secondary outcomes
Duration of mechanical ventilation after transplantation
Time frame: 30 days
ICU length of stay after transplantation
Time frame: 30 days
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 Oct 2013.
- Background: PubMed 21488765Cypel M, Yeung JC, Liu M, Anraku M, Chen F, Karolak W, Sato M, Laratta J, Azad S, Madonik M, Chow CW, Chaparro C, Hutcheon M, Singer LG, Slutsky AS, Yasufuku K, de Perrot M, Pierre AF, Waddell TK, Keshavjee S. Normothermic ex vivo lung perfusion in clinical lung transplantation. N Engl J Med. 2011 Apr 14;364(15):1431-40. doi: 10.1056/NEJMoa1014597.
- Background: PubMed 17184674Oto T, Levvey BJ, Whitford H, Griffiths AP, Kotsimbos T, Williams TJ, Snell GI. Feasibility and utility of a lung donor score: correlation with early post-transplant outcomes. Ann Thorac Surg. 2007 Jan;83(1):257-63. doi: 10.1016/j.athoracsur.2006.07.040.
- Background: PubMed 15848310Aigner C, Winkler G, Jaksch P, Seebacher G, Lang G, Taghavi S, Wisser W, Klepetko W. Extended donor criteria for lung transplantation--a clinical reality. Eur J Cardiothorac Surg. 2005 May;27(5):757-61. doi: 10.1016/j.ejcts.2005.01.024.
- Background: PubMed 17532422Steen S, Ingemansson R, Eriksson L, Pierre L, Algotsson L, Wierup P, Liao Q, Eyjolfsson A, Gustafsson R, Sjoberg T. First human transplantation of a nonacceptable donor lung after reconditioning ex vivo. Ann Thorac Surg. 2007 Jun;83(6):2191-4. doi: 10.1016/j.athoracsur.2007.01.033.
- Background: PubMed 22386450Valenza F, Rosso L, Coppola S, Froio S, Colombo J, Dossi R, Fumagalli J, Salice V, Pizzocri M, Conte G, Gatti S, Santambrogio L, Gattinoni L. beta-adrenergic agonist infusion during extracorporeal lung perfusion: effects on glucose concentration in the perfusion fluid and on lung function. J Heart Lung Transplant. 2012 May;31(5):524-30. doi: 10.1016/j.healun.2012.02.001. Epub 2012 Mar 3.
- Background: PubMed 16678604Botha P, Trivedi D, Weir CJ, Searl CP, Corris PA, Dark JH, Schueler SV. Extended donor criteria in lung transplantation: impact on organ allocation. J Thorac Cardiovasc Surg. 2006 May;131(5):1154-60. doi: 10.1016/j.jtcvs.2005.12.037.
- Background: PubMed 21620034Valenza F, Rosso L, Pizzocri M, Salice V, Umbrello M, Conte G, Stanzi A, Colombo J, Gatti S, Santambrogio L, Iapichino G, Gattinoni L. The consumption of glucose during ex vivo lung perfusion correlates with lung edema. Transplant Proc. 2011 May;43(4):993-6. doi: 10.1016/j.transproceed.2011.01.122.
- Derived from this study: PubMed 24628890Valenza F, Rosso L, Coppola S, Froio S, Palleschi A, Tosi D, Mendogni P, Salice V, Ruggeri GM, Fumagalli J, Villa A, Nosotti M, Santambrogio L, Gattinoni L. Ex vivo lung perfusion to improve donor lung function and increase the number of organs available for transplantation. Transpl Int. 2014 Jun;27(6):553-61. doi: 10.1111/tri.12295. Epub 2014 Apr 4.
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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.
Franco Valenza, MD principal investigator
Fondazione Ca' Granda IRCCS Ospedale Maggiore Policlinico Milan Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EVLP Group in people with Disorder Related to Lung Transplantation and Brain Death, run by Policlinico 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?
The sponsor lists 2 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: finished, as of the sponsor's last update on 23 Oct 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Primary Graft Dysfunction 72 hours after lung transplantation (PGD72) (time frame: 72 hours). The study lists 2 primary outcomes in all. 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 NCT01967953, which also lists 8 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 23 Oct 2013.