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)

Papworth Hospital NHS Foundation Trust0 个研究点目标入组 50 人开始时间: 2023年11月27日最近更新: 2024年7月29日

适应症

试验速览

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•1. Age over 18 years old
•2. Listed for a heart transplant in the UK
•3. All categories of listing including urgent and super-urgent
•4. All pathologies leading to the requirement for heart transplant
•5. Second, third or subsequent heart transplants within the same individual will be eligible provided this subsequent transplant does not occur in an emergency setting during the same hospital admission as the index heart transplant. The index transplant would remain eligible for inclusion in the trial in this case.
•6. Patients who are simultaneously enrolled in other trials will be considered eligible to take part in this study

•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 transplant
•3. 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 heart
•4. Patients who receive hearts from DBD donors procured using the organ care system device or normothermic regional perfusion (NRP). This rarely occurs
•5. Patients receiving a heart-lung block or a multi-visceral transplant

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