Respiratory disease Respiratory Other diseases of the respiratory system
Conditions
Interventions
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 bypa
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
United Kingdom
Outcome results
None listed