About the trial
More information about why the study is needed and the potential benefits it may bring.
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.
About the trial
The Statins for Improving orGaN outcome in Transplantation (SIGNET) trial is a single blinded, randomised controlled trial of Simvastatin in organ donors.
It will recruit 2,600 patients after the diagnosis of death by neurological criteria. A single dose of Simvastatin will be given after consent from the donor’s family.
The primary outcome is a composite of death, use of renal replacement therapy or mechanical cardiac support in cardiac recipients at 28 days. There are secondary clinical end points for other organ transplants as well as organ utilisation.
The SIGNET study will be the largest global RCT ever performed in organ donation.
SIGNET is registered on the ISRCTN registry 11440354.
For more information about the trial please contact our team at SIGNET@nhsbt.nhs.uk