A feasibility study for a randomised controlled trial of two different preservative fluids for heart transplantation.

INTERVENTION: Donor cardiac organ retrieval will proceed according to the nationally standardised protocol, as set by the National Organ Retrieval Service (NORS). The only change to the protocol will be the randomisation, using SealedEnvelope, to receive either Custodial‐HTK or St. Thomas’ solution. Donor hearts included in the study will be randomly allocated on a 1:1 basis to receive either Custodiol‐HTK or St Thomas’ solution as cardioplegia and preservative solution during the organ retrieval process. For the Custodiol‐HTK (treatment) arm: Following cross‐clamping of the ascending aorta, at least 3.5L of cold Custodiol‐HTK will be perfused into the aortic root, over at least 10 minutes at a perfusion pressure of 40‐50mm Hg. The heart will then be stored in 2L of cold Custodiol‐HTK solution for transport. For the St Thomas’ Solution (Control arm): Sterile Concentrate for Cardioplegia Infusion (SCfCI) will be diluted by adding 20ml of SCfCI to 1 litre of Ringers solution. Following cross‐clamping of the ascending aorta, the correct volume of reconstituted SCfCI will be perfused into the aortic root according to the donor weight as outlined below: ‐ Donor weight 30‐70 Kg: administer 1 litre of reconstituted SCfCI solution ‐ Donor weight >70 Kg: administer 1.5 L of reconstituted SCfCI solution ‐ At the request of the recipient transplant surgeon, it is permissible to change the above doses depending on logistics and/or donor physiology. The delivery pressure will be 60‐90 mmHg and the heart will be stored in 2L of cold 0.9% sodium chloride solution, as is standard practice according to the UK NORS protocol. Participants (recipients of donor cardiac allografts that have received one of the above treatments as part of the random allocation process) will be blinded to their tre CONDITION: Organ preservation during cardiac transplantation ; Surgery PRIMARY OUTCOME: The proportion of eligible hearts randomised that receive the correct intervention, once recruitment ceases after 50 patients have successfully been recruited. This is anticipated to be not more than 18 months from recruitment beginning. SECONDARY OUTCOME: The following secondary endpoints will be analysed 30 days after the final recruited patients undergoes their transplant:; 1. Dataset completion rate; 2. The development of Primary Graft Dysfunction, according to the 2014 ISHLT Consensus Definition; 3. Cardiac Power Output Inde Xat admission to ICU and at 6h post‐operation; 4. 30‐day mortality; 5. Time to death within the limits of the study; 6. Development of postoperative complications: Dysrhythmias; myocardial infarction; stroke; transplant rejection; infection (from any source); venous thromboembolism; 30‐day re‐admission; hyponatraemia (Na<125mEq/L); 7. Length of ICU stay; 8. Length of hospital stay; ; INCLUSION CRITERIA: 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 inde Xheart transplant. The inde Xtransplant 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