Statins for Improving Organ Outcome in Transplantation (SIGNET)
Research type
Research Study
Full title
Statins in Organ Donor Management An evaluation of the benefits of a single dose of Simvastatin given to potential organ donors declared dead by neurological criteria on outcomes in organ recipients
IRAS ID
288722
Contact name
John Dark
Contact email
Sponsor organisation
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Eudract number
2021-000047-44
ISRCTN Number
ISRCTN11440354
Duration of Study in the UK
4 years, 11 months, 30 days
Research summary
We wish to investigate whether giving deceased organ donors a single dose of the commonly prescribed drug, Simvastatin, is beneficial for transplant recipients.
All donated organs have suffered some damage. As the brain dies chemicals are released which cause an “inflammation” of the body. Measurements of this “inflammation” link to how well the organs function after transplant. We know that statins have many benefits, including dampening down inflammation in the body and individual organs.Doctors in Finland linked this information in a clinical study. Organ donors, donating their heart, were randomised to receive a statin. The recipients who received a heart from a donor who had statins had less heart damage. This was a small study but there was a small benefit for lung and liver recipients and no disadvantage in receiving any organ from a donor who had received the drug.
A significant number of organs offered for transplant are not used; for the heart, this figure is about 75%. The reason for being so selective is that poor function of the donor heart in the recipient is the most common cause of death after a transplant. Any step in the donor which might improve the transplanted heart, or other organ, could have a major benefit to the recipient.
We plan to enrol 650 adult brain dead donors across the UK per year in a randomised controlled trial. Half the donors will receive Simvastatin in addition to standard care, compared to standard care only. The drug will be given after the donor family have consented to both organ donation and involvement in research.
Half of the recipients will receive a heart from a donor given the drug. We will follow the results of transplant, using data already collected in the national transplant database. No extra data or blood samples will be needed.REC name
London - Queen Square Research Ethics Committee
REC reference
21/LO/0412
Date of REC Opinion
28 Jun 2021
REC opinion
Further Information Favourable Opinion