Investigating the effect Aspirin on hemodialysis permanent catheters
Design
parallel group, randomized, not blinded, phase 3 clinical trial on 74 patients.
Settings and conduct
All patients have medical records and are visited every 6 months. Patients who have not completed drug treatment or do not return will be excluded from the study. The correct and complete functioning of the catheter is evaluated in 6-month intervals. The change in the patency of permanent catheters following the intervention is the outcome of the study. The checklist is completed by the researcher to check the performance of the catheter.
Participants/Inclusion and exclusion criteria
mentally healthy patients with end stage kidney disease with right jugular catheter, who are willing to take the medication, and do not have a history of previous hemorrhagic disease and previous right jugular catheter.
Intervention groups
The study will be completed by clinical trial method with a sample size of 74 people in two groups of 37 patients of chronic renal failure with permanent right jugular catheter who refer to the mentioned dialysis center. The first group takes oral Aspirin 80 mg daily for one year and the second group is the control and does not receive any medication.
Main outcome variables
Extending the patency of permanent hemodialysis catheters
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221220056873N1
Registration date:2023-04-18, 1402/01/29
Registration timing:registered_while_recruiting
Last update:2023-04-18, 1402/01/29
Update count:0
Registration date
2023-04-18, 1402/01/29
Registrant information
Name
Mohammad farshad Zeinali baghini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2247 5984
Email address
mfzb0731@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-17, 1402/01/28
Expected recruitment end date
2024-04-16, 1403/01/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study on the effect of Aspirin on patency rate of permanent hemodialysis catheters in ESRD patients
Public title
Study on effect of Aspirin on permanent hemodialysis catheters patency rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
End stage kidney disease(ESRD) patients
No history of psychiatric illness
Consent to take the medication
Right jugular permanent hemodialysis catheter
Ability to communicate socially
Exclusion criteria:
Previous right jugular catheter
Bleeding disorders history
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of samples to groups by random four block method with permutations (AABB-ABAB-ABBA-BABA-BAAB-BBAA) where the letter A represents the intervention group and B represents the control group. Each of the blocks is given a code from 1 to 6, and the researcher randomly selects a number from 1 to 6 and corresponding to the extracted code of the selected block and corresponding to the permutations of the selected block of samples will be assigned to two groups.
Blinding (investigator's opinion)
Not 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 golestan university of medical sciences
Street address
Surgery department, 5azar hospital, 5azar street
City
Gorgan
Province
Golestan
Postal code
4917763681
Approval date
2023-01-25, 1401/11/05
Ethics committee reference number
IR.GOUMS.REC.1401.558
Health conditions studied
1
Description of health condition studied
end stage renal disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Permanent hemodialysis catheter patency rate
Timepoint
Evaluating the catheters patency 6 and 12 months after the placement and aspirin prophylaxis
Method of measurement
The criterion for the proper functioning catheter is patients complete hemodialysis session using 200 cc per minute speed, which is confirmed by the complete dialysis checklist.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Oral aspirin 80 milligram tablet (from Jalinous company) will be taken daily for 1 year after right jugular permanent catheter placement, and the patency of the patient's catheter is evaluated by a checklist in two 6-month intervals from the start of use.
Category
Treatment - Drugs
2
Description
Control group: Patients with right jugular permanent hemodialysis catheter, who do not receive any medication in the period of one year, and like the intervention group, are evaluated by the checklist in two intervals of 6 months in terms of the correct functioning (patency) of the catheter.
research affairs, second floor, central library, falsafi complex, shastkola road
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Fax
+98 17 3245 1657
Email
mirbeh@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Farshad Zeinali Baghini
Position
General surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
5azar hospital, 5azar street
City
Gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 21 2247 5984
Fax
Email
Mfzb0731@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad farshad Zeinali baghini
Position
General surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
5azar hospital, 5azar street
City
Gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 21 2247 5984
Fax
Email
Mfzb0731@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Farshad Zeinali Baghini
Position
General surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
5azar hospital, 5azar street
City
Gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 21 2247 5984
Fax
Email
Mfzb0731@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All of the study's data will be available after deidentification
When the data will become available and for how long
The access period starts one year after publication
To whom data/document is available
data would be available for all researchers working in academic institutions and businesses
Under which criteria data/document could be used
There is no specific limitation.
From where data/document is obtainable
Dr Mohammad Farshad Zeinali Baghini, mobile: 09190257085, Email: mfzb0731@gmail.com
What processes are involved for a request to access data/document
After sending the request and explaining the reason for the request and the subject to be studied, the data will be provided to the requester as soon as possible.