Does surgically closing a branch of the cephalic vein in the arm affect the openness of an arteriovenous fistula (a connection between an artery and a vein created to allow access to a kidney dialysis machine) in the forearm?
| ISRCTN | ISRCTN12288675 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12288675 |
| Secondary identifying numbers | 15043 |
- Submission date
- 23/09/2019
- Registration date
- 26/09/2019
- Last edited
- 01/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
The People’s Hospital of Zhengzhou University
Zhengzhou
450003
China
 ORCID ID |
0000-0001-6187-7066 |
|---|---|
| Phone | 15116191748 |
| 1277341892@qq.com |
Study information
| Study design | Single-centre randomised controlled interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use a contact details to request a participant information sheet. |
| 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 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2013 |
| Completion date | 28/02/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 58 |
| Total final enrolment | 115 |
| Key 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 |
| Key exclusion criteria | 1. Patients without a cephalic vein dorsal branch 2. Patients who were unable to provide informed consent |
| Date of first enrolment | 01/02/2014 |
| Date of final enrolment | 01/02/2015 |
Locations
Countries of recruitment
- China
Study participating centre
Zhengzhou
450003
China
Sponsor information
Hospital/treatment centre
No.7 Weiwu Rd
Zhengzhou
450003
China
| Phone | (0371)65580070 |
|---|---|
| yanleikidney@126.com | |
| Website | http://www.hnsrmyy.net/ |
"ROR" |
https://ror.org/04tgrpw60 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- 河南省科学技术厅, Department of Science and Technology, Henan Province, Henan Provincial Science and Technology Department, Henan Provincial Department of Science and Technology
- Location
- China
Results and Publications
| Intention to publish date | 01/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 29/04/2020 | 01/05/2020 | Yes | No |
Editorial Notes
01/05/2020: Publication reference and total final enrolment added.
25/09/2019: Trial's existence confirmed by the Key Science and Technology Program of Henan Province.
