Comparison of thrombus rate of dialysis tunneled cuffed catheters in the group receiving rivaroxaban and the control group 2-Comparison of the average patency duration of cuffed tunneled dialysis catheters in the rivaroxaban receiving group and the control group.
Design
Dialysis patients referred to Mashhad province hospital who are candidates for implantation of cuffed tunneled catheter for hemodialysis are randomly assigned to intervention and control groups.
Settings and conduct
50 patients referred to the Vascular Surgery Department of Mashhad Province Hospital for the placement of a tunneled cuffed dialysis catheter during 1403 will be randomly assigned to two control and intervention groups. The analyst will be unaware of the intervention and control groups.
Participants/Inclusion and exclusion criteria
All ESRD patients who are candidates for tunneled cuffed catheter implantation for dialysis.
Intervention groups
In the intervention group, 10 mg of rivaroxaban is given to the patient immediately after insertion of the cuffed catheter. In the control group, no medication is given to the patient after insertion of the dialysis cuffed catheter according to the standard protocol.
Main outcome variables
Incidence of intraluminal thrombosis in the first, third and sixth months after catheter insertion. The rate of catheter opening in the first, third and sixth months after catheter insertion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211026052874N1
Registration date:2025-01-11, 1403/10/22
Registration timing:registered_while_recruiting
Last update:2025-01-11, 1403/10/22
Update count:0
Registration date
2025-01-11, 1403/10/22
Registrant information
Name
Jamal Jalili Shahri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3804 7201
Email address
jalilisj@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-10, 1403/05/20
Expected recruitment end date
2025-02-09, 1403/11/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the Rivaroxaban 10mg on Tunneled cuffed catheter patency in hemodialysis patients
Public title
Study of the Rivaroxaban 10mg on Tunneled cuffed catheter patency
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
ESRD patients who are candidates for Tunneled hemodialysis catheter placement as a permanent hemodialysis access
Exclusion criteria:
Presence of a coagulation disorder
Two weight ranges (less than 50 kg and more than 150 kg)
Receiving anticoagulant medication for another reason, such as cardiac DVT, atrial fibrillation, or an artificial heart valve
Untreated malignant lesion of the central nervous system (CNS)
Active lesion or active malignancy in the GI and GV system
Platelet count less than 70,000
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to two intervention and control groups in order of arrival and based on a randomization sequence that will be generated in advance, which is an unpredictable sequence and its arrangement is completely random. A block randomization method with blocks of 8 will be used to allocate samples. Thus, using the site www.sealedenvelope.com, blocks of 8 letters A and B will be randomly generated based on the sample size. The order of the letters A and B in each block from the first block to the last block is considered as the randomization sequence. The generation of these blocks and their random sequence is entirely done by this site, and the researcher is not aware of their sequence.
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyst will be unaware of the intervention and control groups
Placebo
Not used
Assignment
Other
Other design features
The patients are divided into two researcg groups and control groups
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Thrombosis of cuffed catheter with tunneled dialysis
Timepoint
one month and three months and six months
Method of measurement
Catheter patency rates in the first, third, and sixth months after catheter insertion and cases of catheter dysfunction due to intraluminal thrombosis in both intervention and control groups
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Dialysis patients with a tunneled cuffed catheter are given one 10 mg rivaroxaban tablet daily. Patients are followed up at one, three, and six month intervals, and the number of catheter dysfunctions due to thrombosis is recorded.
Category
Treatment - Drugs
2
Description
Control group: After insertion of a cuffed dialysis catheter according to the current routine treatment process, no medication is given to the patient. Patients are followed up at one, three, and six month intervals and the number of cases of catheter dysfunction due to thrombosis is recorded.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat Hospital
Full name of responsible person
Dr Jamal Jalili Shahri
Street address
Shahid Kaveh Blvd.,
City
Mashhad
Province
Razavi Khorasan
Postal code
9177890001
Phone
+98 51 3872 2147
Fax
+98 51 3872 2139
Email
Jalilisj@mums.ac.ir
Web page address
https://velayat.mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.majid ghayour mobarhan
Street address
Shahid Kaveh Blvd., Velayat Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9177890001
Phone
+98 51 3872 2137
Fax
+98 51 3872 2139
Email
Jalilisj@mums.ac.ir
Web page address
https://velayat.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Jamal Jalili Shahri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shahid Kaveh Blvd., Velayat Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9177890001
Phone
+98 51 3842 9500
Email
Jalilisj@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Jamal Jalili Shahri
Position
َAssistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Vascular Surgery
Street address
ُShahid Kaveh Blvd., Velayat Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9177890001
Phone
+98 51 3872 2137
Email
Jalilisj@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Jamal Jalili Shahri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Vascular Surgery
Street address
Shahid Kaveh Blvd., Velayat Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9177890001
Phone
+98 51 3872 2137
Email
Jalilisj@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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