Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Ms Jessica Qian


Contact details

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

Additional identifiers

EudraCT number 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)



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: and
Protocol can be found at:

Ethics approval

NRES Committee North East – Sunderland, 28/11/2011, ref: 11/NE/0342

Study design

Non-randomised interventional trial

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Respiratory disease


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



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


Overall trial end date


Reason abandoned


Participant inclusion criteria

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


Age group




Target number of participants

Planned Sample Size: 408; UK Sample Size: 408

Participant exclusion criteria

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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Institute of Health and Society
Newcastle Upon Tyne
United Kingdom

Sponsor information


Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

Royal Victoria Infirmary
Leazes Wing
Queen Victoria Road
Newcastle Upon Tyne
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Cystic Fibrosis Trust (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


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


United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date


Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

23/02/2016: No publications found, verifying study status with principal investigator