F-CUSToS: Feasibility study of Custodiol-HTK vs St Thomas' Solution in cardiac transplantation
Research type
Research Study
Full title
Feasibility study for Randomised Controlled Trial of Custodiol-HTK vs St Thomas’ solution for cardioplegia and cold static storage of UK donor hearts in cardiac transplantation (F-CUSToS)
IRAS ID
1007011
Contact name
Marius Berman
Contact email
Sponsor organisation
Royal Papworth Hospital NHS Foundation Trust
ISRCTN Number
ISRCTN11985512
Research summary
Background: Donor hearts are injected with a preservative fluid to protect them during transport to the transplant recipient. Currently, there are two different fluids used for this purpose in the UK, St Thomas’ solution and Custodiol-HTK. St Thomas’ is the standard fluid used in most UK transplants. Some animal studies and data from previous transplants have suggested that Custodiol-HTK may preserve the heart better. However, we do not know if this is true, because no one has ever tested this in a controlled way in humans.
Aims: We aim to conduct a randomised controlled trial (RCT) - the gold standard in research - to compare the two fluids. To test whether there is truly a difference, we need to collect data from around 450 patients. This will take a long time. Therefore, we first want to test if enough patients will consent to take part in the study to make it realistically possible. This is called a feasibility study.
Methods: We intend to ask all UK heart transplant recipients whether they wish to be involved in the trial. If they do, we will randomly allocate hearts to receive either Custodiol-HTK or St Thomas' solution before they are transplanted. We will do this for 50 hearts, which should take less than 1 year. The primary aim of the project is to see if more than two-thirds of eligible heart transplant recipients consent to take part and go on to receive a heart that has been correctly randomised.
Benefits: We believe that by conducting this feasibility study we can prove that it is possible to conduct the RCT. We believe that by conducting the RCT we can finally answer the question: “Which preservative fluid should we use in heart transplantation?” and, if one is shown to be better, change practice in the UK, saving the lives of transplant recipients.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
23/EE/0224
Date of REC Opinion
23 Nov 2023
REC opinion
Further Information Favourable Opinion