Organ rejection Other
Conditions
Interventions
The participant will be randomised either to receive lung alone or lung and skin flap transplantation. If randomised to lung and skin flap transplantation then at the time of their lung transplant a s
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Intended recipient of a lung transplant 2. Aged 18 years or over 3. Capable of giving informed consent
Exclusion criteria
Exclusion criteria: 1. Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to comply with trial procedures 2. Severe peripheral vascular disease with no vessels available for inset of the skin flap
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lung rejection event in the first 12 months, diagnosed by clinical criteria and/or biopsy (ISHLT grade A=1 for lung) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Diagnostic accuracy (sensitivity, specificity, negative predictive value and positive predictive value) of the sentinel skin flap compared to current reference standard (biopsy and/or clinical diagnosis): collected over 12 months 2. Safety of SSF transplant: number of rejection events: 2.1. Number and severity of skin flap rejection episodes (defined by biopsy BANFF grade = 1) and time to first rejection diagnosis measured using biopsy in the first 12 months after transplant 2.2. Transplanted lung and patient survival measured at 12 months 2.3. Transplant lung function measured using lung function tests at 12 months 2.4. Surgical complications and complications relating to the SSF (such as infection, skin loss, nerve injury) measured using clinical parameters at 12 months 2.5. Development of de-novo donor specific antibodies measured using blood tests at 12 months 2.6. Development of graft versus host disease measured using blood chimerism at 12 months 2.7. Evidence of chronic rejection in lung measured using international criteria at 12 months 3. Immunosuppression levels and requirements measured using drug monitoring at 12 months 4. HRQoL as measured by the following validated questionnaires: SF-36; EQ-5D-5L and DAS-24 at baseline, 6 and 12 months. | — |
Countries
England, United Kingdom
Contacts
Public ContactCharles Malyon
Outcome results
None listed