HTA - 10/82/01: A Study of Donor Ex-vivo Lung Perfusion in UK Lung Transplantation: DEVELOP-UK
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|Project title||A Study of Donor Ex-vivo Lung Perfusion in UK Lung Transplantation: DEVELOP-UK|
|Research type||Primary Research|
|Status||Waiting to publish|
|Start date||January 2012|
|Chief Investigator||Professor Andrew Fisher|
|Co-investigators||Dr Thomas Chadwick (Newcastle University), Mr John Dark (The Newcastle Upon Tyne Hospitals NHS Foundation Trust), Professor Thomas Jaki (Lancaster University), Mr Oli Lewington, Dr Nandor Marczin (Imperial College London), Mr Jorge Mascaro (University Hospitals Birmingham NHS Foundation Trust), Ms Karen Redmond, Mr Steven Tsui (Papworth Hospital NHS Foundation Trust), Professor Nizar Yonan (University Hospital of South Manchester NHS Foundation Trust), Dr Mark Deverill (University of Newcastle upon Tyne), Professor Elaine McColl (University of Newcastle upon Tyne), Dr Mark Pearce (Newcastle University), Professor Catherine Exley (Newcastle University)|
|Contractor||University of Newcastle upon Tyne|
|Plain English summary||Unfortunately, many patients who would benefit from a lung transplant sadly die before suitable donor lungs become available. The shortage of organ donors in the UK is made even more dramatic for those waiting for lung transplant as donor lungs are particularly delicate and are easily damaged by events that happen before their removal from the donor. This means that only 1 in 5 of the potential donor lungs available in the UK are currently used in lung transplants. In the DEVELOP-UK study we will test a new technique called ex-vivo lung perfusion or EVLP, to find out how effective it is at safely increasing lung transplant numbers by transforming previously unusable donor lungs into lungs which can be safely used for transplant. EVLP involves attaching donor lungs, after they are removed from the donor, to a modified heart-lung bypass machine which pumps a specialised nutrient liquid through them while at the same time provides the lungs with oxygen via a breathing machine. The DEVELOP-UK study will carefully assess the results of lung transplants performed with EVLP-reconditioned lungs compared to those done with standard donor lungs. Donor lungs offered for transplant but unusable due to damage, will be transferred to the transplant centre where they will be placed on EVLP. The lungs will then be monitored over a number of hours to measure how well their function improves and to make sure there is no irreversible damage or major infection present. If they are reconditioned and able to pass a careful assessment, they will be given to a patient awaiting lung transplant who has given their prior agreement. The study will be deemed a success if we can show that survival in the first 12 months after transplant is comparable in the 2 groups. However, we will also carefully check that there are no more early complications, such as a longer stay on intensive care or more frequent infections or episodes of transplant rejection in the EVLP donor lungs compared to standard lungs.|
|Scientific summary||DEVELOP-UK is a non-randomised, non-inferiority observational study with an adaptive design to evaluate the clinical and cost effectiveness of lung transplantation performed using EVLP assessed and reconditioned donor lungs compared with lung transplantation using standard donor lungs. This multi-centre study involving all 5 officially designated NHS adult lung transplant centres is open to all adult patients aged 18 years and over with advanced lung disease already on an active lung transplant waiting list in one of the 5 centres and any new adult patients as they are added to the waiting list. EVLP is a novel technique in which unusable donor lungs which are functioning poorly or in which function is uncertain, can be further assessed and potentially reconditioned for safe use in clinical lung transplantation. EVLP is performed outside the donor or recipient body by connecting the lungs to a modified heart-lung bypass machine and pumps a specialised perfusate through them while they are simultaneously ventilated. EVLP provides the opportunity to carefully assess donor lung function including gas exchange ability over a number of hours before making a decision on their usability for transplantation. The study is designed to demonstrate non-inferiority of EVLP in terms of 12 month survival. If the study runs to full recruitment then at least 306 patients would be required in the standard arm and 102 in the EVLP arm to give more than 80% power. This makes allowance for a group sequential design that has been used to inflate the sample sizes for the 2 planned interim analyses. The 90 day and 12 month mean cost of undertaking lung transplant using EVLP lungs and standard donor lungs will be assessed. QOL will be determined using the SF-36 in all recipients at 90 day and 12 month post-transplant time points. In addition, qualitative focused interviews with patients waiting and the same number following lung transplant will explore attitudes towards choice and experiences of receiving EVLP treated donor lungs.|
Protocol (PDF File - 1.5 MB)
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