The purpose of this study was to evaluate the effect of aspirin on Permcath function of dialysis patients. This study is a double blind clinical trial. 236 patients referred to Imam Reza Hospital for embedding Permcath randomly divided into two groups: control and intervention group. The intervention group received 80 mg aspirin a day after placing Permcath daily for 6 months and the control group didn’t get any drug. Then they would be examined for infection, bleeding at Permcath site, gastrointestinal bleeding and lifetime of Permcath once a month for 6 months.
Inclusion criteria: Patients who are allowed to receive aspirin, matched for age, sex, diabetes, cardiovascular disease and written informed consent.
Exclusion criteria: Patients who have coagulation disorders or use anticoagulant drugs, patients who are suffering from cancer or gastrointestinal bleeding.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013100114333N8
Registration date:2013-10-14, 1392/07/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-10-14, 1392/07/22
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2013-09-21, 1392/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of effects use and without use of aspirin on Permcath function in dialysis patients
Public title
Study of aspirin effects on Permcath function in dialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients who are allowed to receive aspirin, matched for age, sex, diabetes, cardiovascular disease and written informed consent.
Exclusion criteria: Patients who have coagulation disorders or use anticoagulant drugs, patients who are suffering from cancer or gastrointestinal bleeding
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
236
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2013-07-23, 1392/05/01
Ethics committee reference number
16790/پ/7/420
Health conditions studied
1
Description of health condition studied
Advanced renal failure
ICD-10 code
N18.5
ICD-10 code description
End stage renal disease
Primary outcomes
1
Description
infection
Timepoint
Once a month for 6 months
Method of measurement
Based on physical examination, blood culture and discharge from permcath location
2
Description
Bleeding from Permcath location
Timepoint
Once a month for 6 months
Method of measurement
History and physical examination based on the initial amount of bleeding which doesn’t stop with primary cares and needs to surgical intervention.
3
Description
gastrointestinal bleeding
Timepoint
Once a month for 6 months
Method of measurement
blood in the stool or clinical signs such as bloody vomiting and abdominal pain
4
Description
lifetime of Permcath
Timepoint
Once a month for 6 months
Method of measurement
Observing the patient’s record
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group received 80 mg aspirin a day after placing Permcath daily for 6 months
Category
Treatment - Drugs
2
Description
The control group didn’t get any drug.
Not applicable
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr. Mehran Beglari
Street address
Emam Reza Hospital,Razi Boulvard,Sorkhleje
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
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 Affairs, Kermanshah 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Ezatolah Sadeghi
Position
Vascular Surgeon
Other areas of specialty/work
Street address
Emam Reza Hospita,lRazi Boulvard,Sorkhleje
City
kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
ezatolahsadeghi@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)