First patient joins new dialysis study
We are delighted to announce that the first patient has joined StAFF, a new research study designed to show the best option for safe, long-lasting access to blood vessels for patients who require haemodialysis but have sub-optimal blood vessels.
Haemodialysis is a medical procedure designed to remove waste products and excess fluid from the blood when the kidneys are no longer able to do so. During this process, blood passes through an external filtration machine for cleaning before being returned to the patient. The key part of this process is how patients are physically joined to the machine – vascular access.
The traditional approach, used in all patients until recently, was to create a join between the artery and vein - an arteriovenous fistula (AVF), that enlarges and allows the dialysis tubes to be linked to the patient’s blood vessel system during haemodialysis. However, while this works well in patients with large blood vessels, the failure rate is higher for certain patients including those with smaller blood vessels, diabetes, or peripheral arterial disease. If the AVF doesn’t work, the next step is usually another operation, and in the meantime a catheter (or line) is placed if dialysis is required before a new AVF will be ready. Catheters last the least amount of time and can have the highest rate of complications. To reduce catheter use, many people will have their AVF made before dialysis is thought to be needed, and as many as one in three will never need to use their AVF.
How can we improve blood vessel access in haemodialysis?
Arteriovenous grafts (AVG) are an alternative approach to AV fistulas. AVG are man-made tubes that are placed under the skin between the artery and vein during an operation, allowing the blood vessel access required for haemodialysis. While AVG are often more successful than AVF at the start, they require additional care and maintenance. StAFF researchers will study which approach is most effective during this trial.
Professor David Kingsmore, chief investigator on the StAFF study explained “Although haemodialysis is necessary for many kidney disease patients, this procedure has remained largely unchanged for many years and represents a significant burden for both the patient and their families. We know that access to blood vessels can be especially problematic and hope that through this study we can find out the best approach for those patients most likely to suffer complications."
What is the StAFF study?
StAFF, supported by Kidney Research UK, and NHS Greater Glasgow and Clyde, is a randomised, controlled trial aiming to include 360 patients from across the UK and Europe. Patients can join the study when they are referred for vascular access surgery if their blood vessels are not ideal for AVF surgery, at which point they will be randomly assigned to either an AVF within 6 months of needing to start dialysis, or an AVG within 2 weeks of the dialysis start date.
Who can join StAFF?
To join StAFF you need to be a patient at one of these hospitals; Queen Elizabeth University Hospital, Glasgow; Guys and St Thomas, London; Barts, London; Cardiff and Vale, Cardiff.
If you have veins and arteries that are large and healthy, then an AVF is usually the best approach. However, for people who may have issues with their blood vessels it is not clear what is the best option – an AVF early, or an AVG when needed? Both approaches are offered routinely but we don’t know which is better in terms of healthcare outcomes or quality of life. The StAFF study will help to answer this question and will only include patients who are not likely to have a successful AVF.
A second study (PAVia) will follow-on from StAFF. PAVia will help to determine the best approach to treating the leading complication seen in AVG over the longer term: narrowing in where the AVG is joined to the vein. This study is open to anyone with an AVG who develops this problem for the first time.
What does StAFF PAVia mean?
StAFF stands for A Randomized Trial of Initial Strategy of Acuseal versus Fistula First in Incident Patients Requiring Haemodialysis with Sub-Optimal Options for An Arteriovenous Fistula.
PAVia is A Randomised Trial of Plain Angioplasty vs. Viabahn Stent Graft as First Intervention For Venous Stenosis in arteriovenous Grafts .
The StAFF study will use a type of AVG manufactured by a company called Gore. Elaine Davies, director of research operations at Kidney Research UK noted “Dialysis is an area in need of innovation and we are delighted to be working with Professor Kingsmore and Gore to improve the provision of safe and effective long-term access for patients who need haemodialysis”.
The challenge of life on haemodialysis: a patient’s perspective
We are committed to supporting projects like StAFF PAVia to help improve the experience of dialysis for our patients
"My first fistula failed. my community nurses didn’t know what to look for to spot the signs. My second fistula is loud and clear, but if I’d known that I could potentially be left with several scars before I finally got a fistula that worked, I may have declined the invitation to go ahead with the second one. I wish I could have had discussions about what other options might have been available and better suited to me like a surgical graft." Ayesha Edmondson
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