Evaluating the effect of Warfarin on hemodialysis catheter failure prevention
Design
Randomized clinical trial with control group , randomized with random allocation software, population in each group is 43
Settings and conduct
This study is going to take place in Alzahra hospital in Isfahan city.
All of the studied patients undergo standard surgical procedure for the hemodialysis permanent catheter embedding and a skilled target surgeon perform all of the procedures.The resident of general surgery is going to follow the patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age above 18 years-old,patients who were a candidate for second time permcath placement.Informed consent for participation.
Exclusion criteria:History of major hemorrhages, progressive diabetic retinopathy, less than 12 months of life-expectancy because of systemic disease or malignancies, poorly controlled hypertension, platelet less than 100000,INR≥1.3,PTT≥ 5 folds than the normal, hypersensitivity to Warfarin, active peptic ulcer, pregnancy or lactation,documented aortic aneurysm
Intervention groups
Treatment with Warfarin was initiated for the participants in the intervention group (Warfager tablet, Hoger Danesh Daroo company,Iran) as soon as the cessation of the surgical procedure and its dose was adjusted in order to set INR in the range of 1.5-2.The control group did not receive any anticoagulants and discharged after the surgery.
The intervention group received IV Heparin initially.All of the used permcaths in this study are the same and from the Arrow company made in Ireland. INR was checked monthly in order to adjust the warfarin dose if needed.
Main outcome variables
Finding a method to reduce the thrombosis risk and catheter failure.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200516047461N1
Registration date:2020-05-20, 1399/02/31
Registration timing:retrospective
Last update:2020-05-20, 1399/02/31
Update count:0
Registration date
2020-05-20, 1399/02/31
Registrant information
Name
parto nasri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2088
Email address
parto.nasri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-05, 1398/10/15
Expected recruitment end date
2020-04-08, 1399/01/20
Actual recruitment start date
2020-01-05, 1398/10/15
Actual recruitment end date
2020-04-08, 1399/01/20
Trial completion date
2021-03-05, 1399/12/15
Scientific title
Evaluating the effects of Warfarin on permacath function in hemodialysis patients
Public title
The effects of Warfarin on permacath function
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who were a candidate for the second time embedding of permanent arteriovenous catheters
Informed consent to participate in the study
Age above 18 years old
Exclusion criteria:
History of major hemorrhages (requiring blood transfusion, retroperitoneal or intracranial hemorrhage, inducing hypovolemia, leading to more than two units decrease in hemoglobin) within the previous three months
Progressive diabetic retinopathy
Less than 12 months of life-expectancy because of systemic disease or malignancies
Poorly controlled hypertension (systolic blood pressure>200 mmHg or diastolic blood pressure>100 mmHg measured three times within two weeks)
Absolute platelet count less than 100000
International normalized ratio (INR)≥1.3
Partial thrombin time (PTT)≥ 5 folds than the normal range
Hypersensitivity to Warfarin
Active peptic ulcer
Pregnancy or lactation
Documented aortic aneurysm
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
86
Actual sample size reached:
86
Randomization (investigator's opinion)
Randomized
Randomization description
The study population divided into two groups (intervention and control ) by using Random Allocation software.
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 Isfahan university of medical sciences
Street address
Hezar Jerib Street,Isfahan university of medical sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-04-20, 1398/01/31
Ethics committee reference number
IR.MUI.MED.REC.1398.266
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)
Primary outcomes
1
Description
Permcath function
Timepoint
In every hemodialysis session
Method of measurement
Catheter clotting defined as the gross visible occlusion of the catheter or the dialysis performance with less than 250 ml per minute velocity
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: According to the inclusion and exclusion criteria 86 patients (43 in the intervention group and 43 patients in the control group) recruited. The patients are a candidate for second-time permcath placement. All of the studied patients undergo standard surgical procedure for the permanent hemodialysis catheter embedding a skilled target surgeon performs all of the procedures and all of the embedded catheters are from the Arrow Company made in Ireland. In the next step, treatment with warfarin initiate for the participants in the intervention group (Warfager tablet, Hoger Danesh Daroo company made in Iran) as soon as the cessation of the surgical procedure and its dose will be adjusted in order to set INR in the range of 1.5-2. Furthermore, INR will be checked monthly in order to adjust the warfarin dose if needed, and prevent from any probable warfarin-induced hemorrhagic event. The participants were discharged on the next day of catheter embedding and were re-visit monthly until a year following the surgery to a requirement for the excision of the catheter. Besides, in order to initiate warfarin therapy, the baseline INR was recorded from the laboratory tests of the patients taken before the surgical procedure of permanent catheter embedding.
Category
Prevention
2
Description
Control group: 43 Patients in the control group undergo a standard surgical procedure for the permanent hemodialysis catheter embedding. A skilled target surgeon performs all of the procedures, and all of the embedded catheters are from the Arrow Company made in Ireland. The control group did not receive any anticoagulants and discharged after the surgery. The participants will be re-visited monthly until a year following the surgery to a requirement for the excision of the catheter.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-zahra hospital
Full name of responsible person
Milad Golshani nasab
Street address
Soffeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
milad.golshani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Vice-Chancellery for Research and Technology
Street address
Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
international@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice-Chancellery for Research and Technology
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
Esfahan University of Medical Sciences
Full name of responsible person
Milad Golshani nasab
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5555
Email
milad.golshani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Milad Golshani nasab
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5555
Email
milad.golshani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Milad Golshani nasab
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5555
Email
milad.golshani@gmail.com
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
After making the patients' personal information unrecognizable, the data can be published and shared.
When the data will become available and for how long
Three months after publishing the results, the data will be accessible.
To whom data/document is available
Medical researchers
Under which criteria data/document could be used
The documented data is going to be presented to the Vice-Chancellery for Research and Technology of Isfahan University of medical sciences and the publisher journal.
From where data/document is obtainable
The Vice-Chancellery for Research and Technology of isfahan university of medical sciences
What processes are involved for a request to access data/document
Referring to the Vice-Chancellery for Research and Technology of Isfahan University of medical sciences and having a confirmation from the chief executor of the research the documentation can be accessible.