The incidence of hand ischaemia following different techniques for formation of elbow arteriovenous fistula

ISRCTN	ISRCTN86060133
DOI	https://doi.org/10.1186/ISRCTN86060133
Protocol serial number	N/A
Sponsor	Cambridge University Hospitals NHS Foundation Trust (UK)
Funder	Addenbrooke's Hospital (UK)

Submission date: 27/01/2010
Registration date: 04/05/2010
Last edited: 16/11/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Aaron Goh
Scientific

Department of Transplant Surgery
Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom

Email	aaron.goh@nhs.net

Study information

Primary study design	Interventional
Study design	Prospective randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Randomised controlled trial comparing incidence of hand ischaemia following creation of either conventional brachiocephalic fistula or proximal ulnar/radial-cephalic fistula
Study objectives	The risk of developing dialysis access-associated steal syndrome is lower in proximal ulnar/radial-cephalic fistula group than in brachiocephalic fistula group.
Ethics approval(s)	Cambridgeshire 1 Research Ethics Committee pending approval as of 28/01/2010
Health condition(s) or problem(s) studied	End stage renal failure for permanent dialysis
Intervention	The patients recruited for the trial would be randomised to have either conventional branchiocephalic fistula formation or fistula formation using proximal radial or ulnar artery. The patients suitable for elbow AV fistula would be identified in nephrology clinic and then referred to vascular assess clinic where the patients who are suitable for the trial would be consented. The patients recruited would be randomised to have one of the two techniques of fistula formation. They would be put onto the next available list for fistula formation which would be carried out by experienced transplant specialist registrars or senior clinical fellows. Immediate post-operative outcomes would be recorded. The first follow up would be carried out in vascular assess clinic 2 to 3 weeks after the operation where patients would have digital pressure measurement and would be assessed for presence of symptoms suggesting of fistula-associated hand ischaemia. Further follow up would be carried out at monthly intervals in the first 3 months and then three-monthly thereafter. Patients who develop hand ischaemia symptoms would be assessed immediately by the vascular assess team at Addenbrooke's Hospital either when the patient self present or via referral by their local dialysis unit. The intended follow-up period is up to 12 months.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Presence of dialysis access-associated steal syndrome: 1. Digital pressure measurement 2. Symptoms: cold hand, pain, finger sensibility, strength, cramps 3. Signs: capillary refill time, ulcers, gangrenes 4. Requirement for intervention, surgical revision or ligation Measured at post-operative vascular assess clinic 2 to 3 weeks after the operation or at any timepoint when patients develop ischaemic symptoms up to 12 months follow-up.
Key secondary outcome measure(s)	1. Primary (unassisted) patency rate 2. Secondary (assisted) patency rate 3. Complications: haemorrhage, wound infection, stenosis, thrombosis, aneurysm Assessed at follow up clinic at monthly interval for the first 3 months and then 3-monthly thereafter.
Completion date	31/05/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	70
Key inclusion criteria	1. Aged 17 to 90 years, either sex 2. Suitable for elbow autogenous arteriovenous (AV) fistula as primary or secondary access for haemodialysis
Key exclusion criteria	Patients unable to give consent
Date of first enrolment	01/06/2010
Date of final enrolment	31/05/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Addenbrooke's Hospital

Cambridge
CB2 0QQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

16/11/2017: No publications found in PubMed, verifying study status with principal investigator.