Plain English Summary
Background and study aims
When people need regular hemodialysis (filtering waste and unneeded water from the blood by pumping the blood through a machine and then passing it back into the patient) because their kidneys have failed, they need to have a site of easy access to the blood created. An arteriovenous fistula (AVF) is where a vein and an artery, usually in the forearm, are connected together surgically. This creates higher blood flow in this section of vein, which stimulates the vein to grow stronger walls and a larger opening. The AVF allows the vein to be regularly punctured in two places to allow blood to be pumped out to the dialysis machine and back into the arm from the machine without damaging the vein.
It is thought that ligating (tying closed) a part of the cephalic vein (one of the blood vessels that carries blood from the hand back towards the heart) might help the AVF stay open and strong. This study aims to investigate this by comparing AVFs created with and without ligating part of the cephalic vein.
Who can participate?
Adults who need an AVF to enable regular hemodialysis.
What does the study involve?
Participants will be randomly allocated into two groups. Both will have an AVF created as usual, except that one group will also have the dorsal branch of the cephalic vein ligated.
What are the possible benefits and risks of participating?
In general, there is not any harmful effects for all participants of the two groups.
Where is the study run from?
The People’s Hospital of Zhengzhou University (China)
When is the study starting and how long is it expected to run for?
January 2013 to February 2016
Who is funding the study?
The Key Science and Technology Program of Henan Province (China)
Who is the main contact?
Mrs Lu Yang, 1277341892@qq.com
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Lu Yang
ORCID ID
http://orcid.org/0000-0001-6187-7066
Contact details
The People’s Hospital of Zhengzhou University
Zhengzhou
450003
China
15116191748
1277341892@qq.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
15043
Study information
Scientific title
Does ligation of the dorsal branch of the cephalic vein affect the patency of a distal forearm arteriovenous fistula of maintenance hemodialysis patients? A randomised study
Acronym
Study hypothesis
We aimed to compare the patency of the radiocephalic arteriovenous fistula (RCAVF) in patients with and without ligation of the dorsal branch of the cephalic vein.
Ethics approval
Approved 27/02/2014, Ethics Committee of Zhengzhou University People’s Hospital (Huanghe Rd/Jinger Rd, Zhengzhou, China, +86 87160680; hnsrmyykyll@163.com), ref: 15043
Study design
Single-centre randomised controlled interventional 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 a contact details to request a participant information sheet.
Condition
Arteriovenous fistula created with and without ligation of the dorsal branch of the cephalic vein
Intervention
All patients included in were randomly divided into two groups, the group with ligation of the dorsal branch of the cephalic vein and the group without ligation of the dorsal branch of the cephalic vein, by sealed-envelope randomization. All patients underwent arteriovenous fistula (AVF) surgery, with the dorsal branch ligated or unligated. Participants were follolwed up and the AVF assessed at 90, 180, and 360 days after the surgery.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Primary patency rate of the AVF, defined as the time from the establishment of the fistula to initial percutaneous transluminal angioplasty (PTA) or application of another intervention method to maintain the fistula patency
Secondary outcome measures
1. Secondary patency rate of the AVF, defined as the time from fistula establishment to fistula abandonment, or thrombosis needing a re-establishment of a new fistula
2. Blood flow of the AVF recorded by the hemodialysis machine at 90, 180, and 360 days after the surgery
3. Venous pressure of the AVF recorded by the hemodialysis machine at 90, 180, and 360 days after the surgery
4. AVF diameter assessed by duplex ultrasound using a color Doppler ultrasound machine at 90, 180, and 360 days after the surgery
5. AVF blood-flow volume assessed by duplex ultrasound using a color Doppler ultrasound machine at 90, 180, and 360 days after the surgery
6. Physical examination of AVF condition, with palpation, auscultation and identification of AVF thrill, at 90, 180, and 360 days after the surgery.
Overall trial start date
01/01/2013
Overall trial end date
28/02/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Cephalic vein dorsal branch, confirmed via vein mapping before the procedure
2. Surgical procedure assessed as feasible by experienced surgeons via clinical assessment of the arterial pulse, expansion of the vein after blocking the proximal blood flow with a tourniquet, and bilateral arm blood pressure. Moreover, bilateral vascular assessment, including vascular diameters and arterial blood flow, was performed by duplex ultrasound.
3. Adequate arterial blood flow to the hand, confirmed by negative findings obtained on Allen’s test preoperatively
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
58
Total final enrolment
115
Participant exclusion criteria
1. Patients without a cephalic vein dorsal branch
2. Patients who were unable to provide informed consent
Recruitment start date
01/02/2014
Recruitment end date
01/02/2015
Locations
Countries of recruitment
China
Trial participating centre
The People’s Hospital of Zhengzhou University
No. 7 Weiwu Road
Zhengzhou
450003
China
Sponsor information
Organisation
The People’s Hospital of Zhengzhou University
Sponsor details
No.7 Weiwu Rd
Zhengzhou
450003
China
(0371)65580070
yanleikidney@126.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Science and Technology Department of Henan Province
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a journal.
IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication
Intention to publish date
01/12/2019
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
2020 results in https://www.ncbi.nlm.nih.gov/pubmed/32349711 (added 01/05/2020)