Organ transplantation Surgery
Conditions
Interventions
This is a multi-centre, single-blind prospective, group sequential, randomised controlled trial. Randomisation will be in a 1:1 ratio and will be stratified according to whether the donor was receivin
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Within a recruiting Intensive Care Unit 2. Patients diagnosed dead using neurological criteria 3. Consent for organ donation in place, as defined by the Human Tissue Act and accompanying legislation and Codes of Practice 4. Study-specific consent from the donor family
Exclusion criteria
Exclusion criteria: 1. Aged <18 years 2. Planned donation after cessation of circulation (DCD) 3. Known donor allergic hypersensitivity to simvastatin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Updated primary outcome measure as of 01/05/2024: The primary outcome measure is a composite outcome of death, cardiac mechanical circulatory support or renal replacement therapy within the first 30 days post heart transplant Previous primary outcome measure: Composite of death, cardiac mechanical circulatory support or renal replacement therapy, determined by the recipient status on the UK Transplant Registry (UKTR) at 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Organ utilisation rate, measured by the proportion of organs offered that were transplanted for each organ separately and based on the records held by the UK Transplant Registry (UKTR) during the 60-month trial duration, records completed at 30-days or at initial discharge post-transplant whichever is sooner 2. Graft survival for all transplanted organs, based on the records held by the UKTR, at 30 days, 3 months and 12 months 3. Patient survival, determined by status on the UKTR, at 30 days, 3 months and 12 months 4. Length of ITU stay, measured by the number of days the patient was on ITU, based on the records held by the UKTR from the point of transplant to discharge from ITU at discharge from transplant admission 5. Length of hospital stay, measured by the number of days the patient was in hospital, based on the records held by the UKTR excluding kidney recipients at from the point of transplant to discharge from hospital at discharge from transplant admission 6. Proportion of heart recipients requiring mechanical circulatory support up to 30 days, based on the records held by the UKTR 7. Proportion of cardiac recipients requiring renal replacement therapy up to 30 days, based on the records held by the UKTR 8. Patient survival for heart recipients, measured by their status on the UKTR, at 30 days 9. Number of treated rejection episodes for each organ, based on records held by the UKTR, at 3 and 12 months 10. Estimated glomerular filtration rate for kidney recipients, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (2009) from data held by the UKTR at 12 months 11. Proportion of kidney recipients with delayed graft function, defined as the need for dialysis in the first 7 days, based on records held by the UKTR 12. Number of days liver recipients spent ventilated, based on records held by the UKTR at 30 days or at initial discharge post-transplant whichever is sooner 13. Proportion of liver recipients with individual | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Outcome results
None listed