Contact information
Type
Scientific
Primary contact
Ms Jessica Qian
ORCID ID
Contact details
Institute of Health and Society
4th Floor
William Leech Building
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom
-
jessica.qian@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
11451; HTA 10/82/01
Study information
Scientific title
A study of Donor Ex-Vivo Lung Perfusion in United Kingdom lung transplantation (DEVELOP-UK)
Acronym
DEVELOP-UK
Study hypothesis
The DEVELOP-UK study is designed to investigate the clinical effectiveness and cost effectiveness of a new technology called ex-vivo lung perfusion or EVLP. EVLP is a novel technique in which unusable donor lungs which are functioning poorly or in which function is uncertain, can be carefully assessed and potentially improved for safe use in clinical lung transplantation.
EVLP is performed outside the organ donors or transplant recipients body by connecting the donated lungs to the EVLP system a modified heart-lung bypass machine. The EVLP system warms the lungs to body temperature and pumps a specialised nutrient solution called perfusate through them. At the same time the lungs are ventilated with oxygen by connecting them to a standard intensive care unit ventilator. EVLP provides the opportunity to carefully assess donor lung function over a number of hours before making a decision on their usability for transplantation.
The primary objective of the study is to determine if survival in the first 12 months after lung transplantation in recipients of EVLP assessed and improved donor lungs (treatment group) is not any worse than that in recipients of standard donor lungs (control group).
The secondary objectives are to measure key early clinical outcomes and changes in quality of life (QOL) in the treatment and control groups in their first post-transplant year. This data will be used to decide if EVLP is a cost effective treatment. In addition patients perceptions of EVLP improved donor lungs will be examined in an interview sub-study. Finally we will evaluate which donor factors and EVLP related characteristics are associated with successful donor lung assessment and improvement and with successful outcomes after transplant.
More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=11451 and http://www.nets.nihr.ac.uk/projects/hta/108201
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0006/55770/PRO-10-82-01.pdf
Ethics approval
NRES Committee North East Sunderland, 28/11/2011, ref: 11/NE/0342
Study design
Non-randomised interventional trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Respiratory disease
Intervention
EVLP reconditioning of lung, The experimental intervention is ex-vivo lung perfusion (EVLP). EVLP is performed outside the donor or recipient body by connecting the lungs to a modified heart-lung bypass circuit which warms the lungs to body temperature and pumps the specialised nutrient solution or 'perfusate' through them.
The standard lung procurement procedure will be followed for donor lungs to be used for EVLP in the study.
Followed up at 12 months
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Survival during the first 12 months after lung transplantation
2. Non-inferiority of EVLP using standard methods for survival data at each interim analysis time point
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/02/2012
Overall trial end date
30/01/2014
Reason abandoned
Eligibility
Participant inclusion criteria
Trial:
1. Male or female patients
2. Adult patients (aged over 18 years)
3. Patients already on or added to the active waiting list for first lung transplant while the DEVELOP-UK study is in its recruitment phase
4. Patients providing informed consent for participation in the DEVELOP-UK study at the time of study commencement or time of listing for transplant
5. Patients reconfirming informed consent for the DEVELOP-UK study on the day of lung transplant
Qualitative substudy:
1. All patients who are eligible for the DEVELOP-UK trial
2. Patients at Newcastle Hospitals NHS Foundation Trust and Royal Brompton and Harefield NHS Foundation Trust only
3. All patients who consent to the DEVELOP-UK trial as a whole and the qualitative study specifically (regardless of whether they receive a transplant)
4. Male & female participants
5. Lower Age Limit 18 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 408; UK Sample Size: 408
Participant exclusion criteria
Trial:
1. Patients aged less than 18 years
2. Patients listed for lung re-transplantation
3. Patients listed for heart-lung transplantation
4. Patients listed for live donor lobar transplant
5. Patients not initially consented or signed EOI form for the DEVELOP-UK study prior to the day of lung transplant
6. Patients not reconfirming consent for the DEVELOP-UK study on the day of lung transplant
7. Patients in the ITU requiring invasive ventilation, ECMO or NovaLung support
8. Patients enrolled in Trials within the preceding 12 months (please discuss with principal and chief investigators)
Qualitative sub-study
All patients who have not consented to the DEVELOP-UK trial from Manchester, Papworth and Birmingham sites.
Recruitment start date
01/02/2012
Recruitment end date
30/01/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Health and Society
Newcastle Upon Tyne
NE2 4HH
United Kingdom
Sponsor information
Organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Sponsor details
Royal Victoria Infirmary
Leazes Wing
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Cystic Fibrosis Trust (UK)
Alternative name(s)
CF
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
01/11/2016
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27897967