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

Not Applicable

Completed

• Conditions: Respiratory disease; Respiratory; Other diseases of the respiratory system

• Registration Number: ISRCTN44922411
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Brief Summary

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27897967 2019 economic evaluation results in: https://www.ncbi.nlm.nih.gov/pubmed/31117992 (added 24/05/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-06
• Study Completion: 2014-01-30
• Last Update Posted: 17 June 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 408

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Survival during the first 12 months after lung transplantation<br> 2. Non-inferiority of EVLP using standard methods for survival data at each interim analysis time point<br>

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures