The effect of Aspirin in prevention of permanent hemodialysis catheter thrombosis and increased internal jugular Venous catheter survival
Design
A clinical trial with a control group, Based on 114 subjects In a sample of two groups of 57 patients
Settings and conduct
In This Study, 114 Patients In Ardabil Fatemi Hospital Were Divided In Two Groups Of Control And Intervention. 57 Patients Were Treated With Aspirin And 57 Patients Were Placed In The Control Group. The Average Useful Time Of The Gugular Vein Catheter Was Recorded After Placement And Compared Between two groups. To Examine Quantitative Data, Independen T-test And For Qualitative Data, Chi Square Test And Fisher's Exact Test Will Be Used If Necessary.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:End Stage renal disease patients requiring permanent hemodyalisis catheter And Patients candidate For hemodyalisis catheter replacemen
Exclusion Criteria: The catheter malfunction since the beginning, Catheter site infection, Previous coagulation abnormalities in patients, and any contraindication for Aspirin usage.
Intervention groups
Intervention Group: 57 Person in intervention group will be treated from day after catheter insertion with Aspirin 80 mg Daily (All Patients Will Use Aspirin From A Pharmaceutical Company).
Control group: 57 Person In controls group will Be provided from the day after the placement of catheter with placebo (Placebo From The Razi Pharmaceutical Company, And 4800 Tablets Will Be Required For A Period Of 3 Months For 60 Patients. Placebo In Terms Of Color, Shape And Size Is The Sames) Will Be Treated.
Main outcome variables
Jugular Vein Catheter Thrombosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181128041785N1
Registration date:2019-02-24, 1397/12/05
Registration timing:retrospective
Last update:2019-02-24, 1397/12/05
Update count:0
Registration date
2019-02-24, 1397/12/05
Registrant information
Name
Mohammad bagher Didarshetaban
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3333 7710
Email address
mb.didarshetaban@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Aspirin in prevention of permanent hemodialysis catheter thrombosis and increased internal jugular venous catheter survival
Public title
Effect of Aspirin in prevention of permanent hemodialysis catheter thrombosis
Blood loss Requiring Either Hospitalization Or Transfusion In The Previous 3 Months
Advanced Proliferative Diabetic Retinopathy
Life Expectancy < 12 Months Because Of Advanced Organ-Systemic Disease Or Malignancy
Uncontrolled Systolic Blood Pressure, BP > 200 mmHg Or Diastolic BP >110 mmHg On Three Different Occasions In A Period Of 2 Weeks
Platelet count < 100,000
INR > 1.3
Partial Thromboplastin Time 5 Seconds Longer Than Control
Patients Receiving Dipyridamole ,Sulfinpyrazone ,Ticlopidine , Clopidogrel ,Or Nonsteroid Anti-inflammatory Drugs
All Bleeding Episode After Aspirin Use Leeding HB Loss>1 Gr/Dl
Catheter Dysfunction From Insertion
Catheter Site Infection
Catheter Replacement More Than 3 Times
Previous Coagulopathy
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of medical sciences
Street address
No. 1, Moallem St, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5613843793
Approval date
2018-12-27, 1397/10/06
Ethics committee reference number
IR.ARUMS.REC.1397.190
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
Catheter Thrombosis
Timepoint
At the begining, Catheter dysfunction in first 3 month
Method of measurement
Direct vision of catheter thrombosis, venous Doppler sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: 57 Person In Intervention Group Will Be Treated From Day After Catheter Insertion With Aspirin 80 mg Daily (All Patients Will Use Aspirin From A Pharmaceutical Company).
Category
Prevention
2
Description
Control group: 57 Person In controls Group Will Be Provided From The Day After The Placement Of Catheter With Placebo (Placebo From The Razi Pharmaceutical Company, And 4800 Tablets Will Be Required For A Period Of 3 Months For 60 Patients. Placebo In Terms Of Color, Shape And Size Is The Sames) Will Be Treated.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemi Hospital
Full name of responsible person
Vakili Mohammad MD
Street address
Fatemi Hospital,Shariati St
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2670
Fax
+98 45 3323 2670
Email
Mb.didarshetaban@arums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
پروانه نفتچی
Street address
Ardabil university of medical sciences, Daneshgah St
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3352 2247
Email
info@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Amin Rezazadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Fatemi Hospital,Shariati St
City
ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2670
Email
Mb.didarshetaban@arums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Amin Rezazadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Fatemi Hospital,Shariati St
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2670
Email
Mb.didarshetaban@arums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Amin Rezazadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Fatemi Hospital,Shariati St
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2670
Email
Mb.didarshetaban@arums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
After unidentified people, the demographic data and the duration of the catheter performance will be used to evaluate the effect of aspirin.
When the data will become available and for how long
Starting the access from 2020
To whom data/document is available
Access will be free for every one.
Under which criteria data/document could be used
Statistical analyzes are allowed on data.
From where data/document is obtainable
Will be contact by Dr Amin Rezazadeh Email.
What processes are involved for a request to access data/document