SIGNAL Study 1.0
Research type
Research Study
Full title
uSing ultrasound scannInG to measure venous wall thickening in arterioveNous grAfts: A feasibiLity study (SIGNAL study)
IRAS ID
272084
Contact name
Alison Charig
Contact email
Sponsor organisation
Portsmouth Hospitals NHS Trust
Duration of Study in the UK
0 years, 6 months, 14 days
Research summary
This is a small feasibility study to see if it is possible to measure the vein wall thickness in an arteriovenous graft (AVG) using ultrasound and to see if thickening of this vein wall leads to stenosis (narrowing) of the graft. The study will be carried out at Queen Alexandra hospital in Portsmouth.
Patients with end stage renal disease (ESRD) need to dialyse in order to remove toxins and excess water from their blood. The best way to dialyse is to have a fistula formed. A fistula is where an artery and a deep vein have been joint together using a superficial vein, in order to provide a safe, easily accessible, high blood flow area to dialyse from. If the ESRD patient does not have a suitable superficial vein to form a fistula with then they will need to have an AVG formed. An AVG is the same as a fistula, only instead of using a superficial vein to connect an artery and a deep vein together, a plastic tube is used.
Unfortunately, the failure rate is very high for AVGs (higher than it is for fistulas), with around 77% of AVGs failing, primarily because of stenosis. Currently there are no surveillance programs for AVGs that monitor the development of stenosis. If we could monitor the vein wall thickness in an AVG, we could identify thickening of the vein wall, which is suspected to lead to stenosis of the graft. Identifying the development of stenosis before it has occurred would allow clinicians to treat the AVG, for example, with antiproliferation balloons, to prevent stenosis from ever occurring and thus, preserving the graft. An inexpensive, safe and practical way to do this would be to use ultrasound, which has not been done before. This is what this study aims to do.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
19/WM/0351
Date of REC Opinion
2 Mar 2020
REC opinion
Further Information Favourable Opinion