A patient at Royal Papworth Hospital NHS Foundation Trust has become the first globally to be recruited to a new international heart surgery research trial.
The trial is investigating a new type of ‘blood product powder’ which helps blood to clot naturally. It will be given to patients who are higher risk of bleeding during complex cardiac operations.
If successful, it could significantly cut the need for blood products, improve outcomes and remove the need for blood to be cross-matched between donor and recipient.
“This is a very exciting new study being run at 13 hospitals across five countries in Europe”, said Professor Andrew Klein, Consultant Anaesthetist, (pictured above) who is leading the study at Royal Papworth Hospital.
The study is supported in the UK by the National Institute for Health and Care Research (NIHR), the nation's largest funder of research happening in the NHS and social care.
“If a patient bleeds at the end of their operation, we would normally give them donated blood, such as cryoprecipitate which helps the blood to clot, and red blood cells and plasma to replace their lost blood,” continued Professor Klein.
“This new type of ‘powder’ is infused into patients before bleeding occurs, with the hope it prevents bleeding in the first place.”
The powder – a type of fibrinogen concentrate - is created from waste products in donated blood, separated and dried.
Because it can be stored in small vials, it takes up less storage space than bags of blood and can be stored at room temperature.
It also has a much longer shelf-life of around two years – compared to blood which is a few months - and does not require ‘blood matching’ to take place. That means anyone can receive it, regardless of their blood type.
“For some patients, their blood has a good natural ability to clot on its own,” added Professor Klein, who is also the Anaesthetics & Pain Management Lead for the NIHR’s regional Clinical Research Network.
“The participants recruited to this study will have blood that is less likely to clot, and therefore more likely to bleed.
“If we can stop people bleeding, the impact could be significant.
“Around 35,000 people need heart surgery in the UK each year, with about 12,000 patients requiring transfusion during or after surgery. Patients can lose one or two pints of blood frequently, while some can lose up to eight pints.
“People who do not need transfusions typically have better outcomes, fewer complications, a shorter length of stay in hospital and quicker recovery.
“We are proud to announce this global first with the first two patients randomised to this ground-breaking study and thank them for being so interested in research.
“Both patients are now doing very well. The team is now working hard to continue to recruit more patients into the study which we hope will benefit many more people.”
Greg, a plumber from Norwich, is the first patient to be recruited to this new heart surgery research trial
The first patient recruited in the world was Greg (69), a plumber from Norwich, who had surgery to repair his mitral valve.
The mitral valve is a small flap in the heart that stops blood flowing the wrong way.
In Greg’s case, he had mitral valve regurgitation, a condition in which the flap does not close properly, causing a backward flow of blood back to the heart, affecting how blood flows around the body.
“It’s an honour and a privilege to the be the first patient randomised to the trial,” said Greg.
“When I was approached about taking part, it was something that I was more than happy to contribute towards.
“I’m very grateful for the support that the NHS has given me, so if I can help be involved in something that proves beneficial for others in the future, then I’m more than happy to do so.
“Heart issues have unfortunately run in my family,” Greg went on to explain.
“My mum had a double-heart bypass when she was 50 and my younger brother had open heart surgery in the early 1960s, when he was born with a 2p-size hole in his heart between his ventricles.
“I knew I had a heart murmur but nothing came up until a year or so ago when I was suddenly really breathless. After tests I was told I had mitral valve regurgitation and following an angiogram it was suggested I have surgery.”
The operation to repair Greg’s mitral valve was successful, and he was discharged home from Royal Papworth Hospital six days later.
Dr Effrossyni Gkrania-Klotsas, Clinical Director for the NIHR’s Clinical Research Network in the East of England, said, “It’s only through research that we can find new ways to help care for people, but without participants like Greg, research couldn’t happen. We are extremely grateful to everyone involved in research, patients, staff and supporters alike, and are privileged to count the Royal Papworth Hospital team as part of our region’s impressive research community”.
In total, it is hoped that 620 participants will be recruited to the double-blind study across Europe. Some patients will receive the drug while others will receive a placebo.
Research and innovation is a strategical aim of Royal Papworth Hospital as we collaborate with partners to bring tomorrow's treatments to today's patients. Discover more about our research here.