Evaluation the effect of Clopidogrel in prevention of access graft thrombosis in upper extrimity in patients undergoing hemodialysis in Emam Reza’s Hospital - Kermanshah,2012-2013
This study is a double blind randomized clinical trial that is aimed to prevent of vascular access graft thrombosis in upper extrimity in hemodialysis patients in Emam Reza hospital in kermanshah, Iran. Inclusion criterion is all the patients with vascular access graft in upper extremity and exclusion criteria are the patients with history of use of anti platelet drugs, coagulation disorders and malignancies. Sample size is 50 in based on statistical analysis. Patients in case & control groups are treated with clopidogrel (antiplatelet) and placebo for 6 months. Patients within 6 months and in the end of study are evaluate by vascular access graft thrombosis in upper extremity.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013012412256N1
Registration date:2013-05-10, 1392/02/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-10, 1392/02/20
Registrant information
Name
Bahman Alinejad
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6311
Email address
dr.bh.alinejad@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah Univercity of Medical Sciences
Expected recruitment start date
2012-10-06, 1391/07/15
Expected recruitment end date
2013-03-05, 1391/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Clopidogrel in prevention of access graft thrombosis in upper extrimity in patients undergoing hemodialysis in Emam Reza’s Hospital - Kermanshah,2012-2013
Public title
The effect of clopidogrel in prevention of access graft thrombosis in upper extremity.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criterion: patients with end-stage renal failure who need to vascular access graft placement in upper extremity for hemodialysis.
Exclusion criteria: pationts with advanced malignancies and hyper coagolation states; pationts with a history of venous access thrombosis; thrombocytopenia (<100000/ml); thrombpcytosis (>450000/ml); erythrocytosis (hematocrite>55%); patients who receiving warfarin, aspirin or other salicylates, dipyridamole,sulfinpyrazone and ticlopidine or other conditions that anti platelet drugs are contraindicated.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
No.2, Shahid Beheshti BLV.
City
kermanshah
Postal code
Approval date
2012-10-03, 1391/07/12
Ethics committee reference number
7/420/29108/پ
Health conditions studied
1
Description of health condition studied
Chronic Renal Failure -Hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic Renal Failure -Dialysis
Primary outcomes
1
Description
Thrombosis
Timepoint
Monthly for 6months
Method of measurement
Dupler Sonography and clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
For all patients in the intervention group,administered tablet clopidogrel 75 mg daily, orally for 6 months and patients were followed during this 6 months and monitored of graft thrombosis .
Category
Prevention
2
Description
For all patients in the control grouop administered a tablet exactly similar to the clopidogrel and is made with starch composition,orally for 6 months, and patients were followed during this 6 months and monitored of graft thrombosis as the intervention group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Masoud Ahmadi
Street address
Hemodialysis Ward- Emem Reza Hospital
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah Univesity of Medical sciences
Full name of responsible person
Mohammad Mahbobi- Research Affairs
Street address
No.2- Shahid Beheshti blv.
City
Kermanshah
Grant name
12480002
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah Univesity 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
Kermanshah Univesity of Medical sciences
Full name of responsible person
Bahman Alinezhad
Position
MD, assistant of general surgery
Other areas of specialty/work
Street address
Emem Reza Hospital
City
Kermanshah
Postal code
67144-15333
Phone
+98 83 1838 5789
Fax
Email
dr.alinezhad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical sciences
Full name of responsible person
Ezatollah Sadegi
Position
Assistant professor of general surjery
Other areas of specialty/work
Street address
Emam Reza hospital -kermanshah
City
Kermanshah
Postal code
67144-15333
Phone
+98 83 1427 6303
Fax
Email
Ezatollah sadegi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical sciences
Full name of responsible person
Bahman Alinezhad
Position
MD, assistaant of general surgery
Other areas of specialty/work
Street address
Emam Reza hospital -kermanshah
City
Kermanshah
Postal code
67144-15333
Phone
+98 83 1838 5789
Fax
Email
dr.alinezhad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)