A study of donor lung perfusion in lung transplantation in United Kingdom

ISRCTN	ISRCTN44922411
DOI	https://doi.org/10.1186/ISRCTN44922411
Secondary identifying numbers	11451; HTA 10/82/01

Submission date: 06/02/2012
Registration date: 06/02/2012
Last edited: 24/05/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Ms Jessica Qian
Scientific

Institute of Health and Society
4th Floor, William Leech Building
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom

Email	jessica.qian@ncl.ac.uk

Study information

Study design	Non-randomised interventional trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A study of Donor Ex-Vivo Lung Perfusion in United Kingdom lung transplantation (DEVELOP-UK)
Study acronym	DEVELOP-UK
Study objectives	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(s)	NRES Committee North East Sunderland, 28/11/2011, ref: 11/NE/0342
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/02/2012
Completion date	30/01/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 408; UK Sample Size: 408
Key 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
Key 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.
Date of first enrolment	01/02/2012
Date of final enrolment	30/01/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Institute of Health and Society

Newcastle Upon Tyne
NE2 4HH
United Kingdom

Sponsor information

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Royal Victoria Infirmary
Leazes Wing
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
England
United Kingdom

Website	http://www.newcastle-hospitals.org.uk/
"ROR"	https://ror.org/05p40t847

Funders

Funder type

Charity

Cystic Fibrosis Trust (UK)
Private sector organisation / Other non-profit organizations

Alternative name(s): Cystic Fibrosis, CF
Location: United Kingdom

Health Technology Assessment Programme
Government organisation / National government

Alternative name(s): NIHR Health Technology Assessment Programme, HTA
Location: United Kingdom

Results and Publications

Intention to publish date	01/11/2016
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2016		Yes	No
Results article	economic evaluation results	22/05/2019	24/05/2019	Yes	No

Editorial Notes

24/05/2019: Publication reference added.
27/03/2018: Publication reference added.
23/02/2016: No publications found, verifying study status with principal investigator.