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Clinical Trials/NCT02297451
NCT02297451CompletedNot Applicable

Randomised Controlled Trial Comparing the Incidence of Steal Syndrome in the Two Types of anTEcubitaL Fossa Arteriovenous fistuLa AVF (STEAL Trial)

Cambridge University Hospitals NHS Foundation Trust2 sites in 1 country79 target enrollmentStarted: February 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
79
Locations
2
Primary Endpoint
Incidence of steal syndrome as measured by Hoek Score

Study Overview

Brief Summary

Background:

Arteriovenous fistula (AVF) is a form of vascular access for haemodialysis. An AVF is normally created at the level of the wrist, but occasionally it is created in the elbow when there is no suitable vessel in the forearm. The most common type of elbow (antecubital) fistula (AFF) is a brachiocephalic fistula, which carries significantly higher risk of steal syndrome (AVF-associated hand ischaemia) than wrist fistulas. More recently, AFF using proximal radial or ulnar artery as inflow has been described and shown to have a lower rate of Steal syndrome than brachiocephalic fistula. This study aims to investigate the incidence of steal syndrome between AFF using brachial artery and that using the proximal radial/ulnar artery as inflow.

Detailed Description

Arteriovenous fistulas (AVF) are the safest form of vascular access for long-term haemodialysis in patients with end-stage renal failure. The strategy in creating an AVF in the upper limbs is to start at a distal site and if that fails, to attempt an AVF on a more proximal site i.e. from wrist, forearm to elbow. The most common type of AVF is the radiocephalic AVF at the wrist. A more proximal AVF is often created as a primary procedure when there is poor vasculature in the distal forearm or as a secondary procedure when a wrist fistula has failed. Traditionally, brachiocephalic fistulas (BCF), which involves anastomosing the cephalic vein to the brachial artery, have been the most common type of AVF created in the antecubital fossa at the elbow level. Other common types of antecubital fossa arteriovenous fistula (AFF) are the brachiobasilic (BBF) and brachio-median cubital AVF.

Steal syndrome relates to hand ischaemia associated with AVF creation, and is a major risk of AVF formation. The symptoms of steal syndrome ranges from cold extremities, numbness, hand claudication (pain after exercise), to rest pain and tissue loss. Steal syndrome can also be measured by Digital Brachial Pressure Index. Severe steal syndrome is debilitating, and limb-threatening, and requires surgical revision or ligation of the AVF. This leads to additional surgical risks and loss of dialysis vascular access.

Diabetes and the types of AVF have been found to be independent risk factors for developing steal syndrome following AVF creation1. The highest risk is seen in patients with a proximal AVF i.e. BCF/BBF; up to 50% of patients in some studies, compared to 5-8% in all upper limb AVFs.

An alternative technique that may reduce risk of steal in this group of patients is to anastomose the vein to the radial artery or ulnar artery, distal to the brachial artery bifurcation. This technique, theoretically, will only 'steal' blood from one artery e.g. radial artery if the anastomosis is created on the proximal radial artery so blood flow can therefore be maintained by the ulnar arterial system.

Recent studies have suggested that using the proximal radial or ulnar artery reduced the risk of steal to as low as 0% to 3%. The type of arterial inflow to an AFF is therefore a potentially significant factor in causing steal syndrome. There is, however, no current randomised controlled trial to prove this hypothesis.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • End stage renal failure Requiring AVF at in the antecubital fossa for haemodialysis

Exclusion Criteria

  • When the participant has not received the allocated intervention due to anatomical anomaly, technical issue or any other reason

Outcomes

Primary Outcomes

Incidence of steal syndrome as measured by Hoek Score

Time Frame: 6 months

Determine the incidence of steal syndrome in the 2 arms of the study

Secondary Outcomes

  • Presence of severe steal syndrome necessitating surgical revision/ligation(6 months)
  • Operative time(6 months)
  • Utilisation of fistula(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Aaron Goh

Clinical Research Fellow

Cambridge University Hospitals NHS Foundation Trust

Study Sites (2)

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