Disorders Related to Lung TransplantationPhase 1EVLP-DCDNCT02061462
EVLP to Evaluate the Eligibility for Transplantation of DCD-Lungs
A Phase 1 study testing EVLP-DCD Group in people with Disorders Related to Lung Transplantation and Graft Failure, run by Policlinico Hospital at 1 site in Italy.
Trial summary
The procurement of organs from donors after cardiocirculatory death (DCD) is an accepted strategy to increase organ supply. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Disorders Related to Lung Transplantation, Graft Failure
- What is being tested?
- EVLP-DCD Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2014to Apr 2017
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Lung donors:
- subjects with brain death according to neurological or cardiocirculatory criteria
- age below 65 yrs
- absence of massive lung contusion, aspiration, pneumonia, sepsis
- absence of infection, malignancy
Recipients:
- subjects to undergo single or bilateral lung transplantation
- informed consent to participate in the study
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS a' Granda - Ospedale Maggiore Policlinico
Milan, Milan, 20122
Franco Valenza, MD, 00390255033232, franco.valenza@unimi.it
About this study
Official title: Extracorporeal Lung Perfusion and Ventilation to Evaluate the Eligibility for Transplantation of Lungs Retrieved From Donors After Cardio-circulatory Death (DCD)
The procurement of organs from donors after cardiocirculatory death (DCD) is an accepted strategy to increase organ supply.
Read the detailed description
Aim of the investigation: to compare the clinical outcome after transplantation of subjects receiving lungs procured from donors after cardiocirculatory death reconditioned and assessed by EVLP, with that of subjects receiving lungs procured from brain death donors.
- Being tested
- EVLP-DCD Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVLP-DCD GroupProcedure or surgery
Events: application of an open lung protective ventilatory strategy (recruitment manoeuvre, low volume-low frequency ventilation-high PEEP) to the DCD donors; procurement of lungs and cold storage on ice; reconditioning/evaluation by EVLP to assess suitability for transplantation; cold storage on ice; transplantation. Endpoints of 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 dead donors. |
| EVLP-DCD Group | Active comparator | Recipients of lungs procured from DCD donors, reconditioned/evaluated by EVLP Receives: Procedure: EVLP-DCD Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 Day Mortality and Graft Survival
30 day mortality and graft survival is used as a standard research measure to evaluate post transplant outcome
Measured: 30 days
Secondary outcomes (3)
Duration of mechanical ventilation after transplantation
Measured: 30 days
ICU length of stay after transplantation
Measured: 30 days
Primary Graft Dysfunction 72 hours After Transplantation
Primary Graft Dysfunction 72 hours after transplantation definition: grade 3 according to the International Society of Heart and Lung Transplantation classification
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2016 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- San Gerardo Hospital
- Responsible party
- Principal investigator, Franco Valenza, MD, Policlinico Hospital
- Investigators
- Franco Valenza, MD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061462
- Sponsor's protocol ID
- EVLP_2013
- Acronym
- EVLP-DCD
- Status last verified
- Nov 2014
- First submitted
- 11 Feb 2014
- Last updated
- 26 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Lung Perfusion and Ventilation to Evaluate the Eligibility for Transplantation of Lungs Retrieved From Donors After Cardio-circulatory Death (DCD)
- ClinicalTrials.gov ID
- NCT02061462
- Acronym / sponsor ID
- EVLP-DCD / EVLP_2013
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Collaborators
- San Gerardo Hospital
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 12 Feb 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 procurement of organs from donors after cardiocirculatory death (DCD) is an accepted strategy to increase organ supply.
Detailed description
Aim of the investigation: to compare the clinical outcome after transplantation of subjects receiving lungs procured from donors after cardiocirculatory death reconditioned and assessed by EVLP, with that of subjects receiving lungs procured from brain death donors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Group | No intervention | –Recipients of lungs procured from brain dead donors. |
| EVLP-DCD Group | Active comparator | Procedure: EVLP-DCD GroupRecipients of lungs procured from DCD donors, reconditioned/evaluated by EVLP |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| EVLP-DCD GroupEvents: application of an open lung protective ventilatory strategy (recruitment manoeuvre, low volume-low frequency ventilation-high PEEP) to the DCD donors; procurement of lungs and cold storage on ice; reconditioning/evaluation by EVLP to assess suitability for transplantation; cold storage on ice; transplantation. Endpoints of suitability: oxygenation, respiratory mechanics, pulmonary vascular resistance, chest X-ray, fibrobronchoscopy | Procedure or surgery | EVLP-DCD Group |
Primary outcome
30 Day Mortality and Graft Survival
Time frame: 30 days
30 day mortality and graft survival is used as a standard research measure to evaluate post transplant outcome
3 secondary outcomes
Duration of mechanical ventilation after transplantation
Time frame: 30 days
ICU length of stay after transplantation
Time frame: 30 days
Primary Graft Dysfunction 72 hours After Transplantation
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2014.
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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.
Fondazione IRCCS a' Granda - Ospedale Maggiore Policlinico
Milan, Italy
Franco Valenza, MD principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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-DCD Group in people with Disorders Related to Lung Transplantation and Graft Failure, 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?
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 26 Nov 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 Day Mortality and Graft Survival (time frame: 30 days). 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 26 Nov 2014.