The aim of performing this study is to investigate the patency of basilic vein transposition with 6 mm prosthetic brachioaxillary access grafts in hemodialysis patients. The study is designed as multicenter randomized double blind clinical trial. Sixty hemodialysis patients who met the inclusion criteria including no possibility of embedding the radiocephalic or brachiocephalic arteriovenous fistula or already created fistula but has been complicated and not to be usable, are divided randomly in one of the two groups (n=30) including basilic vein transposition or brachioaxillary prosthetic 6 mm arteriovenous graft operation group. Then the patency of created dialysis access as primary outcome and their related complications as secondary outcome will evaluated in two studied groups for at least one year follow up of the patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016070726023N1
Registration date:2016-10-13, 1395/07/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-13, 1395/07/22
Registrant information
Name
Pouya Tayebi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5311
Email address
tayebip941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2016-07-10, 1395/04/20
Expected recruitment end date
2017-07-10, 1396/04/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of vascular patency in basilic vein transposition compared to straight 6-mm grafts, as upper arm vascular access, in hemodialysis patients.
Public title
Patency comparison between two different kind of vascular accesses in hemodialysis patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients Suffering end stage renal diseases with no possibility of creating the radiocephalic or brachiocephalic arteriovenous fistula for hemodialysis or they already have fistula but it has been damaged and unusable; No previous Basilic vein transposition or arteriovenous graft in the site of operation; No history of current medication with anticoagulants or antiplatelet agents; Age 30-80 years old.
Exclusion criteria: Anticoagulant or antiplatelet treatment after surgery and during follows up; cease hemodialysis from the created access after the operation for any reason.
Age
From 30 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random numbers table was used for the randomization in this study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical sciences
Street address
Mashhad University of Medical sciences, Daneshgah street
City
Mashhad
Postal code
9177899191
Approval date
2016-08-17, 1395/05/27
Ethics committee reference number
IR.MUMS.fm.REC.1395.91
Health conditions studied
1
Description of health condition studied
Chronic Renal Failure
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Access patency time
Timepoint
2 weeks, 1, 2, 3, 6 months then every 3 months after surgery up to one year
Method of measurement
Observation for finding the evidence of created access obstruction or successful dialysis
Secondary outcomes
1
Description
Presence of a palpable thrill in created access
Timepoint
2 weeks, 1, 2, 3, 6 months then every 3 months after surgery up to one year
Method of measurement
Dialysis Access physical examination for thrill strength and consistency
Intervention groups
1
Description
Intervention group 1: in order to creating dialysis vascular access, surgical operation will be done to perform basilic vein transposition. In this group after explore and superficialisation of the basilic vein, vascular anastomosis will be done with brachial artery.
Category
Treatment - Surgery
2
Description
Intervention group 2: Surgical operation for creating brachioaxillary prosthetic 6 mm graft between axillary vein and brachial artery. In this group after axillary vein and brachial artery exploration the graft passed from the anterior of arm and vascular anastomosis will be done for graft embedding.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Vascular surgery Department
Full name of responsible person
Dr Pouya Tayebi
Street address
Ebne sina Ave, Doctora crossroads
City
Mashhad
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Vascular Surgery Department
Full name of responsible person
Dr Mahdi Davoudi
Street address
Razi Ave
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Vice chancellor of research, Ghoreishi building, Daneshgah st.
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Pouya Tayebi
Position
Fellowship of Vascular Surgery
Other areas of specialty/work
Street address
Imam Reza Hospital, Vascular Surgery Department
City
Mashhad
Postal code
Phone
+98 51 3841 2088
Fax
Email
tayebip941@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Pouya Tayebi
Position
Fellowship of Vascular Surgery
Other areas of specialty/work
Street address
Imam Reza Hospital, Vascular Surgery Department
City
Mashhad
Postal code
00985138412088
Phone
+98 51 3841 2088
Fax
Email
tayebip941@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Pouya Tayebi
Position
Fellowship of Vascular Surgery
Other areas of specialty/work
Street address
Imam Reza Hospital, Vascular Surgery Department
City
Mashhad
Postal code
Phone
+98 51 3841 2088
Fax
Email
tayebip941@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)