SIGNET
SIGNET will be the largest randomised controlled trial in organ donation. The trial will evaluate the benefits of Simvastatin given to organ donors on outcomes in organ recipients.
​
-
The SIGNET study opened to recruitment in September 2021.
-
SIGNET will be the largest randomised controlled trial in organ donation, positioned perfectly to coordinate the unique strengths of the UK NHS infrastructure. It will evaluate the benefits of Simvastatin given to organ donors on outcomes in organ recipients.
-
There is evidence that Simvastatin, a safe and commonly used drug, might limit the damage sustained by a donor heart before it is transplanted.
-
This drug has not been tested in large scale trials which assess outcomes important to patients.
-
The SIGNET study will evaluate the benefits of a single dose of Simvastatin given to potential organ donors declared dead by neurological criteria on outcomes in organ recipients.
INCLUSION CRITERIA
-
Patients confirmed dead using neurological criteria
-
Consent for organ donation in place, as defined by the Human Tissue Act and accompanying legislation and Codes of Practice
-
Within a recruiting Intensive Care unit
EXCLUSION CRITERIA
-
Aged under 18
-
Refusal of consent from donor family
-
Planned donation after cessation of circulation (DCD)
-
Known hypersensitivity to Simvastatin
Study Information
The SIGNET trial is generally well embedded in King's Critical Care
and is supported through the specialist nurses in organ donation, supported by ACEt when needed.
