Comparison of thrombus rate of artificial dialysis vessel in rivaroxaban receiving group and control group
Comparison of the average length of time the artificial dialysis vessel remained open in the group receiving rivaroxaban and the control group.
Design
A clinical trial with a control group with a simple blinded three-way parallel group on 78 patients for randomization from the site Randomization.com was used
Settings and conduct
Dialysis patients referred to the Vascular Surgery Department of Velayat Hospital who undergo artificial vein implantation for dialysis are randomly divided into two intervention and control groups.
Participants/Inclusion and exclusion criteria
Criteria for entering the study:
1- Dependence on hemodialysis or the need for hemodialysis in the near future
2- Installing a new artificial vein for dialysis
Exclusion criteria:
1-Recent major bleeding (in the last 6 months) defined as follows:
Bleeding requiring transfusion Bleeding in a high-risk area (retroperitoneal or intracranial), Bleeding that caused a decrease in body volume or hospitalization, or Bleeding that caused a Hg drop of more than 2 gr/dl.
2-Inability to eat oral medicine
3- Taking anticoagulant medicine for another reason
4- Survival of less than two months or waiting for recovery of kidney failure
Intervention groups
In the intervention group, after implanting an artificial dialysis vessel to the patient, 2.5 daily. mg of rivaroxaban is given for six months.
In the control group, no anti-coagulant or anti-platelet drugs are given to the patient after the implantation of the artificial dialysis vessel.
Main outcome variables
Thrombosis rate of artificial vein in one, three and six months after implantation of artificial dialysis vessel
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231108059994N1
Registration date:2023-11-25, 1402/09/04
Registration timing:retrospective
Last update:2023-11-25, 1402/09/04
Update count:0
Registration date
2023-11-25, 1402/09/04
Registrant information
Name
Ali Zangouei aval
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 938 814 9272
Email address
zangoueia4001@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-21, 1402/01/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
2023-03-21, 1402/01/01
Actual recruitment end date
2023-10-23, 1402/08/01
Trial completion date
2024-03-01, 1402/12/11
Scientific title
Studying the effect of Rivaroxaban 2.5 mg daily on Arteriovenous hemodialysis graft maintenance and thrombosis
Public title
Studying the effect of Rivaroxaban 2.5 mg daily on Arteriovenous hemodialysis graft maintenance and thrombosis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Dependence on hemodialysis or the need for hemodialysis in the near future
Installing a new artificial vein for dialysis
Exclusion criteria:
Recent major bleeding (within the last 6 months) that is defined as follows: bleeding requiring transfusion, bleeding in a high-risk area (retroperitoneal or intracranial), bleeding that caused a decrease in body volume or hospitalization, or bleeding that caused Hg drop is more than 2 gr/dl.
Inability to take oral medication
Anticoagulant use for another reason
Life expectancy of less than two months or waiting for recovery of renal failureOpen in
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
78
Actual sample size reached:
78
Randomization (investigator's opinion)
Randomized
Randomization description
simple
The envelope method is that the envelopes will be prepared and printed by a member of the research team and random numbers with the help of Randomaize.com and placed inside the envelope. The lid of the envelopes will be closed and its contents will not be visible from the outside. Then, first, the purpose of the study is explained to the person who meets the stated conditions, and if the person wishes, he signs the informed consent form and takes an envelope, then opens it, and based on the contents of the envelope, the person is entered into the intervention or control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The envelope method is that the envelopes will be prepared and printed by a member of the research team and random numbers with the help of Randomaize.com and placed inside the envelope. The lid of the envelopes will be closed and its contents will not be visible from the outside. Then, first, the purpose of the study is explained to the person who meets the stated conditions, and if the person wishes, he signs the informed consent form and takes an envelope, then opens it, and based on the contents of the envelope, the person is entered into the intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad Medical Sciences
Street address
shahid kalantari Blvd. Mashhad University of Medical Sciences
City
mashhad
Province
Razavi Khorasan
Postal code
9137913131
Approval date
2023-06-15, 1402/03/25
Ethics committee reference number
IR.MUMS.IRH.REC.1402.079
Health conditions studied
1
Description of health condition studied
Artificial vein thrombosis in dialysis patients
ICD-10 code
T82.867A
ICD-10 code description
Thrombosis of cardiac prosthetic devices, implants and grafts, initial encounter
Primary outcomes
1
Description
Thrombosis rate of artificial vein in one, three and six months after implantation of artificial dialysis vessel
Timepoint
in one, three and six months after implantation of artificial dialysis vessel
Method of measurement
Occurrence of thrombosis in an artificial vessel
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, after implanting an artificial dialysis vessel to the patient, 2.5 daily. mg rivaroxaban
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
velayat hospital
Full name of responsible person
Ali zangouei
Street address
shahid fakouri
City
mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٨٩۰۰۰١
Phone
+98 51 3872 2140
Email
aliila9071@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mohsen tafaghodi
Street address
shahid kalantari Blvd
City
mashhad
Province
Razavi Khorasan
Postal code
9137913131
Phone
+98 51 3841 2081
Email
ZangoueiA4001@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
Jamal jalili shahri
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Vascular surgeon
Street address
velayat hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
051387240
Email
ZangoueiA4001@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
asscciare professor
Latest degree
Subspecialist
Other areas of specialty/work
Vascular surgeon
Street address
Mashhad velayat hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
051387240
Email
ZangoueiA4001@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali zangouei aval
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
velayat hospital
City
mashgad
Province
Razavi Khorasan
Postal code
9177899191
Phone
051387240
Email
ZangoueiA4001@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