Condition category
Surgery
Date applied
23/09/2019
Date assigned
26/09/2019
Last edited
25/09/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

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

http://www.hnsrmyy.net/

Funders

Funder type

Government

Funder name

Science and Technology Department of Henan Province

Alternative name(s)

Department of Science and Technology, Henan Province, Henan Provincial Science and Technology Department, Henan Provincial Department of Science and Technology

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

China

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

Publication citations

Additional files

Editorial Notes

25/09/2019: Trial's existence confirmed by the Key Science and Technology Program of Henan Province.