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.
About the trial
Recruited so far
1012/2600
patients
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.
SIGNET introduction video
Partners
National Institute for Health Research (NIHR)
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle University
UK Organ Donation & Transplant Research Network
The SIGNET study is funded by the National Institute for Health Research (NIHR) under its Health Technology Assessment Programme (reference NIHR131124). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
The Sponsor of this study is the Newcastle Upon Tyne Hospitals NHS Foundation Trust. The Sponsor has delegated overall management of this study to the Clinical Trials Unit at NHS Blood and Transplant.