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

Phase 4

• Conditions: Organ preservation during cardiac transplantation; Surgery

• Registration Number: ISRCTN11985512
• Lead Sponsor: Papworth Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-27
• Last Update Posted: 29 July 2024
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 50

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 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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
The following secondary endpoints will be analysed 30 days after the final recruited patients undergoes their transplant:<br>1. Dataset completion rate<br>2. The development of Primary Graft Dysfunction, according to the 2014 ISHLT Consensus Definition<br>3. Cardiac Power Output Index at admission to ICU and at 6h post-operation<br>4. 30-day mortality<br>5. Time to death within the limits of the study<br>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)<br>7. Length of ICU stay<br>8. Length of hospital stay<br><br>