Thousands of lives could be saved globally by giving patients a 10p statin before transplants, doctors have said, as the NHS launches the world’s largest clinical trial in organ donors.
The medical breakthrough is predicted to dramatically increase the supply of organs for transplant. Currently, demand for organs vastly exceeds the number available. Every year thousands of people die waiting for a transplant, including hundreds in Britain.
Many potential organs for donation, particularly the heart and lungs, are damaged. Removing the organ and reattaching it in the recipient can exacerbate the damage. As a result, thousands of organs offered can never be used. Three-quarters of hearts offered cannot be used because they are damaged or do not function well.
Now leading doctors, surgeons and researchers say giving all donors a statin before their organs are removed could reduce inflammation and minimise or even reverse that damage. The pioneering act could be of real clinical benefit to organ recipients, significantly boosting their chances of survival.
In a world first, organ donors in the UK involved in a groundbreaking trial are being prescribed a single dose of simvastatin hours before their organs are removed. The intervention costs just 10p and takes only 30 seconds but is set to revolutionise organ donation.
The world’s largest randomised controlled trial in organ donors begins this week and could lead to statins being used routinely to boost the number of transplants performed and their success rate. More than 7,000 patients in the UK alone are waiting for an organ transplant.
The pandemic is likely to increase the need. Severely ill patients may experience lasting lung damage, and other patients due to undergo transplants in the last 18 months have had their operations cancelled.
Prof John Dark, a leading organ donation expert and a lead investigator of the trial, said he was hopeful that giving statins to organ donors would become standard.
The cholesterol-lowering drugs are already one of the world’s most popular medications. “What we hope is that this study will affect practice throughout the world and result in every organ donor being given a statin … with potentially thousands of lives saved,” said Dark.
The Signet trial will recruit 2,600 organ donors after they are declared brainstem dead, under a method called donation after brainstem death (DBD). They will be enrolled at 80 hospitals across the UK over the next four years.
Dark, a professor of cardiothoracic surgery at Newcastle University and a former heart and lung surgeon who has performed more than 500 transplants, said his team would look to confirm the benefits that statins could have on organs including the heart, lungs, pancreas, liver and kidneys.
“We expect better-quality organs to come from donors who have been treated with simvastatin. A previous, smaller study in Finland has shown that this was clearly the case for the heart and hinted at improvements in quality for lungs and liver also.
“Interestingly, in lung donation the recipients who got organs from donors treated with simvastatin showed half the level of primary graft dysfunction, which measures organ damage,” Dark said. “What we hope to do in the future is to make statins part of the standard treatment for organ donors and then explore other drugs that may continue to improve the condition of donated organs.”
In the trial, half of the consented donors will receive a statin in addition to their standard donor care. The drug is given through a tube running into the stomach, already present in most donors. The drug will be administered as soon as the family have consented to organ donation and involvement of their relative in the research. Half of all the recipients will then receive an organ from a donor given the statin.
Lyndsey Fitzpatrick, who has been waiting five years for a heart transplant, welcomed the trial. “It’s wonderful to hear that there’s more research being done into improving the quality of donated organs and hopefully means more hearts will be available for transplant,” she said.
The 36-year-old, from Neston on the Wirral, was born with a heart defect and had her first operation at six weeks old. She had open heart surgery at three and has needed pacemakers since she was 10.
“I’m still waiting for that all-important phone call to say a match has been found for me and I can start the next chapter of my life,” she said. “I hope this study, and more like these in the future, will mean people like me won’t have as long a wait for a transplant as there will be more organs available to save more lives.”
NHS Blood and Transplant (NHSBT) will help deliver the research using specialist nurses in organ donation, who support families giving consent at the end of life. These nurses will have spent months undergoing training enabling them to take part in the trial.
“The importance of the specialist nurses in organ donation can’t be underestimated,” said Dr Dan Harvey, a co-lead investigator of the study. “They do an incredible job in supporting families at one of the hardest times in their lives during the process of organ donation. Family understanding and support are crucial in the success of the trial.”
The study is backed by a £1.3m grant from the National Institute for Health Research (NIHR). It is being run by NHSBT’s clinical trials unit in Cambridge and sponsored by Newcastle upon Tyne hospitals NHS foundation trust.
Prof Paul Dark, the NIHR national specialty lead for critical care, said the trial was vital. “Previous studies have shown statins can reduce inflammation and improve organ quality,” he said. “This new study is critical research which we hope will show major benefits to the recipient donor.”