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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Marius Berman
+44 (0)1223 638000
marius.berman@nhs.net


Dr Group inbox account
+44 (0)1223 638000
papworth.fcustos@nhs.net


Dr Luke Williams
+44 (0)1223 638289
luke.williams5@nhs.net


Study Location:

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Be Part of Research - Trial Details - A feasibility study for a randomised controlled trial of two different preservative fluids for heart transplantation.
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A feasibility study for a randomised controlled trial of two different preservative fluids for heart transplantation.

Recruiting

Open to: All Genders

Age: Mixed

Newcastle upon Tyne Cambridge Manchester Uxbridge Birmingham Clydebank, near Glasgow

Medical Conditions

Organ preservation during cardiac transplantation

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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, it is not known if this is true, because no one has ever tested this in a controlled way in humans. This study aims 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, data from around 450 patients will need to be collected. This will take a long time. Therefore, this study will first test if enough patients will consent to take part in the study to make it realistically possible. This is called a feasibility study.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

14 Oct 2024 04 Sep 2025

All UK heart transplant recipients will be asked whether they wish to be involved in the trial. If they do, they will be randomly allocated with hearts that have received either Custodiol-HTK or St Thomas' solution before they are transplanted. This will be done 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.


Adult patients scheduled to be heart transplant recipients aged over 18 years old

You can take part if:



You may not be able to take part if:


1. Recipients under the age of 18 years old at the time of transplantation (patients listed when under the age of 18 will be eligible if their transplant is conducted on or after the date of their 18th birthday, provided that they have also provided consent to take part in the trial on or after the date of their 18th birthday)2. Emergency re-transplant patients, where the re-transplant occurs within the same admission as the index transplant3. Patients who receive hearts procured from donation after circulatory death (DCD) donors. These patients are excluded from the study because the process of organ retrieval from DCD is very different, involving ex situ perfusion of the beating heart with oxygenated blood, rather than maintenance of the heart in the cold arrested state with a preservative solution. The system for doing this ex situ perfusion is called the organ care system (OCS). Currently approximately 10% of UK heart transplants are performed using a DCD heart4. Patients who receive hearts from DBD donors procured using the organ care system device or normothermic regional perfusion (NRP). This rarely occurs5. Patients receiving a heart-lung block or a multi-visceral transplant


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Freeman Hospital
    Freeman Road High Heaton
    Newcastle upon Tyne
    NE7 7DN
  • Royal Papworth Hospital
    Papworth Road Cambridge Biomedical Campus
    Cambridge
    CB2 0AY
  • Wythenshawe Hospital
    Southmoor Road Wythenshawe
    Manchester
    M23 9LT
  • Harefield Hospital
    Hill End Road Harefield
    Uxbridge
    UB9 6JH
  • Queen Elizabeth Hospital
    Edgbaston
    Birmingham
    B15 2TH
  • Golden Jubilee Hospital
    Agamemnon Street
    Clydebank, near Glasgow
    G81 4DY

Conducting this feasibility study will hopefully prove that it is possible to conduct the RCT. By conducting the RCT the question: “Which preservative fluid should we use in heart transplantation?” can be answered, and, if one is shown to be better, change practice in the UK, saving the lives of transplant recipients.
Both of the preservative solutions involved in this trial have been extensively used and researched in the field of cardiac surgery. They have both also been used in cardiac transplantation around the world for nearly 50 years and have shown to have excellent safety profiles. They both hold MHRA approval for the specific use of myocardial preservative solutions in cardiac transplantation. Although St Thomas' solution is the most used in the UK, as it forms part of the UK standard cardiac retrieval protocol, surgeons can currently choose to use Custodiol-HTK according to their preference. Transplant recipients would not normally be informed which solution has been used. As a result, there is not thought to be any additional risk to participants as a result of taking part in this trial, beyond the risks that they are informed of when consenting to receive a cardiac transplant. The outcomes of recipients will be monitored to assess if there is a difference between the two solutions, as outlined in the secondary aims of this feasibility study.

Dr Luke Williams
+44 (0)1223 638289
luke.williams5@nhs.net


Dr Marius Berman
+44 (0)1223 638000
marius.berman@nhs.net


Dr Group inbox account
+44 (0)1223 638000
papworth.fcustos@nhs.net



The study is sponsored by Papworth Hospital NHS Foundation Trust and funded by Heart Research UK.



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Read full details for Trial ID: ISRCTN11985512

Or CPMS 56717

Last updated 19 December 2024

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