Although Arterio-venous fistulae (AVF) is considered to be vital for chronic kidney disease (CKD) patients, but they may cause complications and problems. For instance they may fail soon after their creation. The most important cause of failure in these cases is intrafistula thrombus formation. Whereas anti-platelet drugs are not routinely used after fistulae creation, we conducted this study to determine the effect of these drugs (aspirin and dipyridamol) on the patency of AVFs. 501 CKD patients who needed hemodialysis were enrolled in the study. 111 patients were excluded by the end of the study due to fail of AVFs function within the first 72 h after the surgery, fail of follow up or drugs disadventages. These failures are mainly the result of technical problems during the operation. After fistulae creation, they were randomly divided in 3 groups. Each group consisted of 130 patients. The first group received aspirin and the second one received dipyridamol and the third one was the control group that received placebo. We collected all data on age, gender, and underlying disease, site of the AVF (Arterio-venous fistulae), extremity dominancy, and effects of aspirin and dipyridamol on patency rate of the AVF.
General information
Acronym
EDPRF
IRCT registration information
IRCT registration number:IRCT201009292220N3
Registration date:2010-11-06, 1389/08/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-11-06, 1389/08/15
Registrant information
Name
Mohamad Reza Sobhiyeh
Name of organization / entity
Shahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8001
Email address
mozafar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2003-06-01, 1382/03/11
Expected recruitment end date
2007-10-01, 1386/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Antiplatelet Drugs on the Patency Rate of Arterio-venous Fistulae in Hemodialysis Patients
Public title
The Effect of Drug on the Patency Rate of Fistulae
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All end stage renal disease (ESRD) patients who needed Arterio-venous Fistulae (AVF) for hemodilysis. Exclusion criteria: bleeding tendency, active peptic ulcer disease, pregnancy, lactation, use of anticoagulant and or non steroidal anti-inflammatory drugs, hepatic insufficiency and history of significant side effects from aspirin or dipyridamol.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
501
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Shahid Beheshti Blv. Daneshjoo Sqr. Velenjak
City
Tehran
Postal code
1985717443
Approval date
2003-06-01, 1382/03/11
Ethics committee reference number
125
Health conditions studied
1
Description of health condition studied
choronic renal failure
ICD-10 code
N18.0
ICD-10 code description
End-stage renal disease
Primary outcomes
1
Description
patency of Arterio-venous fistulae according age ,sex ,site
Timepoint
weekly
Method of measurement
presense or absence Thrill or bruit
Secondary outcomes
empty
Intervention groups
1
Description
75 milligram /day Dipyridamol after creation arterio-venous fistulae
Category
Prevention
2
Description
325 milligram /day Aspirin after creation arterio-venous fistulae
Category
Prevention
3
Description
multi vitamin tablet after creation arterio-venous fistulae
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Surgery, Shohada e Tajrish Hospital
Full name of responsible person
mohsen rozrokh-mohamad reza sobhiyeh
Street address
Department of Surgery,Shohada e Tajrish Hospital,Tajrish Square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.M.Rahmati Rudsari
Street address
Vice-Chancellor for Research, 5th floor, 2nd block, Shahid Beheshti University of Medical Science,Velenjak
City
Tehran
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, Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohamad Reza Sobhiyeh
Position
General Surgen
Other areas of specialty/work
Street address
Department of Surgery, Shohada e Tajrish Hospital,Tajrish Square
City
Tehran
Postal code
1989934148
Phone
+98 21 2271 8000
Fax
+98 21 2272 1144
Email
mreza_sobhiyeh@yahoo.com , mozafar@sbmu.ac.ir
Web page address
sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohsen Rouzrokh
Position
Associated Professor of Pediatric Surgery
Other areas of specialty/work
Street address
Pediatric Surgery Research Center, Mofid Children’s Hospital
City
Tehran
Postal code
1546815514
Phone
+98 21 2222 7021
Fax
+98 21 2292 4489
Email
mohsen_rouzrokh@yahoo.com
Web page address
sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohamad Reza Sobhiyeh
Position
General Surgen
Other areas of specialty/work
Street address
Department of Surgery, Shohada e Tajrish Hospital,Tajrish Square
City
Tehran
Postal code
1989934148
Phone
+98 21 2271 8000
Fax
+98 21 2272 1144
Email
mreza_sobhiyeh@yahoo.com , mozafar@sbmu.ac.ir
Web page address
sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)