For investigators

Information for investigators around trial design, criteria and outcomes.

For more information about the study download our study protocol (PDF 734KB)

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SIGNET is a multi-centre, single-blind prospective, group sequential, randomised controlled trial to evaluate the benefits of a single dose of Simvastatin given to potential organ donors declared dead by neurological criteria on outcomes in organ recipients.

Study hypothesis

Does treatment of potential organ donors with Simvastatin during protocolised care after diagnosis of  death using neurological criteria improve outcomes in patients undergoing transplantation? 

To determine if Simvastatin given to the donor confers an improvement in clinical outcomes in cardiac transplant recipients 
To determine if Simvastatin in the donor has a beneficial effect on other solid organs
To determine if Simvastatin is safe in all organ transplant recipients (cardiac, renal, lung, liver and pancreas)

Eligibility criteria

Participant 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

Participant exclusion criteria

Aged under 18
Refusal of consent from donor family
Planned donation after cessation of circulation (DCD)
Known hypersensitivity to Simvastatin

Study outcomes

n=2600 donors in the UK

Primary Outcome: Composite of death, cardiac mechanical circulatory support or renal replacement therapy within the first 30 days post- heart transplant.  

Secondary Outcomes: Organ utilisation, recipient mortality and secondary markers of organ function for non-cardiac donated organs (lung, liver, kidney, pancreas) will be analysed from routinely collected data from the UK Transplant Registry.

Expression of interest

If you would like to express your interest in your Trust taking part in SIGNET, please complete our Feasibility Questionnaire and send the completed form to SIGNET@nhsbt.nhs.uk.