Condition category
Respiratory
Date applied
06/02/2012
Date assigned
06/02/2012
Last edited
23/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.develop-uk.net

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

http://www.newcastle-hospitals.org.uk/

Funders

Funder type

Charity

Funder name

Cystic Fibrosis Trust (UK)

Alternative name(s)

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

Publication citations

Additional files

Editorial Notes

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