Contact information
Type
Scientific
Primary contact
Mr Aaron Goh
ORCID ID
Contact details
Department of Transplant Surgery
Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom
-
aaron.goh@nhs.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Randomised controlled trial comparing incidence of hand ischaemia following creation of either conventional brachiocephalic fistula or proximal ulnar/radial-cephalic fistula
Acronym
Study hypothesis
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
Cambridgeshire 1 Research Ethics Committee pending approval as of 28/01/2010
Study design
Prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measure
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.
Secondary outcome measures
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.
Overall trial start date
01/06/2010
Overall trial end date
31/05/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
35 patients each arm (70 patients in total)
Participant exclusion criteria
Patients unable to give consent
Recruitment start date
01/06/2010
Recruitment end date
31/05/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Organisation
Cambridge University Hospitals NHS Foundation Trust (UK)
Sponsor details
Research & Development Department
Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Addenbrooke's Hospital (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list