Date: 28 November 2017
A study aiming to reduce the risk of stomach bleeding in aspirin users is believed to be the UK’s largest interventional academic drug trial, after 30,024 patients volunteered to take part.
The study, known as HEAT, was funded and supported by the National Institute for Health Research (NIHR) and closed last month after recruiting patients over a five year period.
In low doses, aspirin is used as a long-term treatment to prevent heart attacks and strokes. Researchers on the study believe that by thinning the blood, aspirin makes ulcers in the stomach bleed. These ulcers may be caused by a particular type of bacteria, and so the study aims to find out whether a short course of antibiotics to remove this bacteria will reduce the risk of bleeding in aspirin users.
Due to the large number of patients that needed to be recruited, the study was delivered with the involvement of 1,260 general practices across the UK.
Professor Chris Hawkey, Chief Investigator of the study at the University of Nottingham explained: “Aspirin use is widespread, especially among the elderly, and there is increasing evidence that it may slow down certain cancers. However, a side effect of long-term use can include ulcer bleeding.
“We know interventional trials are influential, however if the outcome being investigated occurs infrequently, studies need to be conducted on a large scale.”
General practices issued more than 185,000 invitation letters to potential participants aged 60 and over who were daily aspirin users.
In addition to supporting the set-up of the study, the NIHR funded approximately 80 clinical research nurses to then recruit patients.
Jen Dumbleton, Clinical Trials Manager for the study, said: “We didn’t incur any nursing recruitment costs, because we were able to use clinical research nurses available through the NIHR.
“The nurses were able to consent up to 12 patients a day, which is why we were able to recruit in such large numbers.”
Once consented to take part in the study, patients were invited to take a breath test to see whether they had the bacteria in their system. Patients who tested positive were randomised to either receive an active form of the antibiotics, or a placebo treatment.
Ruth Gibbins, NIHR Clinical Research Nurse, said: “This is an important study for patients, clinicians and the NHS because a gastric bleed is a potentially life threatening condition and often results in a substantial stay in hospital.”
“I was fortunate to recruit the first patient to this study within the Wessex region. We often get positive feedback from patients saying that they really value being asked to take part in research because they find it interesting and like to be able to help others.”
Michael Keeble, 66, from Southampton, was one of the patients who took the opportunity to participate in the study.
Mr Keeble said: “I’ve been taking aspirin for over ten years now, and I didn’t actually realise that this bacteria is in the gut, lying dormant and that something can trigger it off. So this is one reason why I thought, ‘well, why not?’ If it’s offered to me then I should take part because it could help me and others.
“I found it very interesting and very easy to follow, there were no problems at all. The appointment takes very little of your time but it could save you a lot of problems going forward.”
Last year, there were almost 17,000 hospital admissions for gastric ulcers and more than 1,850 recorded deaths for gastric and duodenal ulcers. If successful, the study will help to reduce NHS costs and improve health outcomes by reducing hospital admissions, increasing patient safety and preventing premature deaths.
Phil Evans, GP and NIHR National Specialty Lead for Primary Care, said: “The HEAT study is an excellent example of how you can deliver large scale research within the NHS.
“This would not have been possible without the participation of general practices and patients, whose contribution to research is vital if we are to provide improved care and treatment in the future.”
In total, 5,357 patients tested positive for the bacteria, known as H. pylori. These patients will continue to be followed up, with results of the study expected to be published in 2020.
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