The effect of reteplase on the dysfunctional permanent central venous catheter of hemodialysis
Design
The clinical trial with a control group, parallel-group, double-blinded, Randomized, In 60 patients, A randomization method is used with the STATA software.
Settings and conduct
In this study, in patients with impaired hemodialysis central venous catheter function, 0.04 units of reteplase were injected and after 30 minutes, catheter function was evaluated. The study is performed in Ali Ibn Abitaleb Hospital in Zahedan. The patient and the analyst are unaware of the type of injectable drug.
Participants/Inclusion and exclusion criteria
Lack of blood flow in the catheter lumen
ability to aspiration of heparin from the lumen
flow rate less than 150 ml/min
Intervention groups
Intervention group: Injection of 2 ml of Reteplase containing 0.4 units of drug
Control group: Injection of 2 ml of heparin
Main outcome variables
Catheter function correction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201101049227N1
Registration date:2020-11-28, 1399/09/08
Registration timing:prospective
Last update:2020-11-28, 1399/09/08
Update count:0
Registration date
2020-11-28, 1399/09/08
Registrant information
Name
Seyed Morteza Hashemizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5570
Email address
m.hashemizadeh@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-05, 1399/09/15
Expected recruitment end date
2021-06-05, 1400/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of reteplase on the dysfunctional permanent central venous catheter of hemodialysis
Public title
The effect of reteplase on the dysfunctional permanent central venous catheter of hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Lack of blood flow in catheter lumen
ability to aspiration of heparin from lumen
flow rate less than 150 ml/min
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method is used individually with the STATA software.
The software randomly determines whether patients receive heparin or reteplase.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and analysts do not know which group they belong to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of zahedan university of medical sciences
Street address
ZAUMS Main campus, Hesabi square, Zahedan, Sistan and Baluchestan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2020-09-20, 1399/06/30
Ethics committee reference number
IR.ZAUMS.REC.1399.315
Health conditions studied
1
Description of health condition studied
Central venous catheter
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Catheter function correction
Timepoint
30 minutes
Method of measurement
Lumen flow more than 250 ml per minute
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Injection of 2 ml of Reteplase containing 0.4 units of drug
Category
Treatment - Drugs
2
Description
Control group: Injection of 2 ml of heparin
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ebne Abitaleb Hospital
Full name of responsible person
Seyed Morteza Hashemizade
Street address
Salamat Blvd, Persian Gulf Expressway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
public@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Vice-president for Research and Technology
Street address
ZAUMS Main campus, Hesabi square, Zahedan, Sistan and Baluchestan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
zaums.research@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Seyed Morteza Hashemizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Aََََََli-ebn- abitaleb Hospital, Khalij Fars Blvd, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Fax
Email
m.hashemizadeh@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Seyed Morteza Hashemizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Aََََََli-ebn- abitaleb Hospital, Khalij Fars Blvd, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Fax
Email
m.hashemizadeh@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Seyed Morteza Hashemizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Aََََََli-ebn- abitaleb Hospital, Khalij Fars Blvd, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Fax
Email
m.hashemizadeh@zaums.ac.ir
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 data include the outcomes of the two groups can be published after being unidentified.
When the data will become available and for how long
Access to information will be granted after article publishment.
To whom data/document is available
Data will be access by researchers from medical universities.
Under which criteria data/document could be used
Data will be access by researchers from medical universities.
From where data/document is obtainable
Dr. Seyed Moeteza Hashemizade, MD. General surgery resident, Email: dr_hashemizadeh@yahoo.com Tell: +989128206466, Address:Ali ebne Abitaleb Hospital, Salamat Blvd, Persian Gulf Expressway, Zahedan
What processes are involved for a request to access data/document
The people that wanted the data should email requested the data.