The objectives: The aim of this study is to assess the efficacy and safety of a PTFE bridge graft between the superficial femora artery and vein. The result is to compare with the conventional method- the graft placement between the common femoral artery and vein.
The participants are those patients who failed to accomplish the conventional angioaccess procedures.
main outcome measure (variable): The graft primary patency rate in the superficial femoral artery and result is to compare with the common femoral artery.
The planning: This study is a blind randomized clinical trial set up among dialysis patients aged 28 to 86, admitted to the Imam Reza educational Hospital, Kermanshah University of Medical Sciences, who are candidates for the graft placement in the lower extremities.
The main criteria for inclusion: Patients unable to receive the more conventional angioaccess procedures.
The main criteria for exclusion: Patients with malignancy and coagulopathy.
The intervention and methods: a total number of 40 patients are randomly divided into two groups; in the first group (intervention), with the graft being placed between the superficial femoral artery and vein. In the second group having undertaken the conventional method, the graft is placed between the common femoral artery and vein. The both groups are to be visited in the interval of a week and then every three months for up to a year, during which, the patency rate and the complications such as thrombosis, infection, hematoma and pseudoaneurism are to be assessed. The data from each group are to be studied and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013021812514N1
Registration date:2013-05-12, 1392/02/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-12, 1392/02/22
Registrant information
Name
Hojat Bahramabadi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6312
Email address
dr.b.bahramabadi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-11-20, 1391/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison study o fthe PTFE graft patency rate and the complicationsin in the superficial and the common femoral arteries in the dyalysis patents.
Public title
A comparison between the two methods of artificial graft placement in the superficial and the common femoral arteries.
Purpose
Treatment
Inclusion/Exclusion criteria
The main criteria for inclusion: Patients in whom it is not possible more arteriovenous fistulas be accomplished
The main criteria for exclusion: Patients with malignancy and coagulopathy are excluded
Age
From 28 years old to 86 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for research, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd., Kermanshah
City
Kermanshah
Postal code
6714415333
Approval date
2013-01-15, 1391/10/26
Ethics committee reference number
48647
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Comparison of graft patency rate
Timepoint
Every three months
Method of measurement
Surgeon diagnosis
Secondary outcomes
1
Description
pseudoaneurysm
Timepoint
Every three months
Method of measurement
Surgeon diagnosis
2
Description
Graft thrombosis
Timepoint
Every three months
Method of measurement
Surgeon diagnosis
3
Description
Infection
Timepoint
Every three months
Method of measurement
Surgeon diagnosis
4
Description
Hematoma Hematom
Timepoint
Every three months
Method of measurement
Surgeon diagnosis
Intervention groups
1
Description
In the intervention group, the synthetic graft for access to dialysis is placed between the superficial femoral artery and vein.
Category
Treatment - Surgery
2
Description
In the control group using the conventional method, the synthetic graft for access to dialysis is placed between the common femoral artery and vein.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational Imam Reza Hospital, kermanshah univercity of medical sciences.
Full name of responsible person
Bahramabadi Hojat
Street address
The General Surgery DepartmenReza Hospital, Parastar Blvd, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences, Shid Behshti blvd, Kermans
Full name of responsible person
Najafi Farid
Street address
Vice chancellor for research, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd, Kermanshah
City
Kermanshah
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, Kermanshah University of Medical Sciences, Shid Behshti blvd, Kermans
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
Kermanshah University of Medical Sciences
Full name of responsible person
Bahramabadi Hojat
Position
Resident of general surgery
Other areas of specialty/work
Street address
The General Surgery Department, Imam Reza Hospital, Blvd Parasta, Kermanshah
City
Kermanshah
Postal code
6714415333
Phone
+98 831883142763
Fax
+98 83 1427 6343
Email
Dr.B.Bahramabadi@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Keramanshah University of Medical Sciences
Full name of responsible person
Sadeghi Ezatollah
Position
Vasscular Surgen
Other areas of specialty/work
Street address
General surgery Department, Imam Reza Hospital, Blvd Parasta, Kermanshah
City
Kermanshah
Postal code
6714415333
Phone
+98 83 1427 6312
Fax
+98 83 1427 6343
Email
Sadeghi.Ezatollah@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Keramanshah University of Medical Sciences
Full name of responsible person
Bahramabadi Hojat
Position
Resident of general surgery
Other areas of specialty/work
Street address
Genral surgery Department, Imam Reza Hospita, Blvd Parstar, Kermanshah
City
Keramanshah
Postal code
6714415333
Phone
+98 83 1427 6323
Fax
+98 83142763312
Email
Dr.B.Bahramabadi@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)