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Comparative Study of the Hemostatic Effect of Transamin on percutaneous nephrolithotomy surgery

Protocol summary

Study aim
Determination of hemostatic effect of transamine in percutaneous nephrolithotomy.
Design
Clinical trials have two groups: patient and control, which is a blind side.At the beginning of the study, patients receive their own number regardless of the information in the file, which will be randomly assigned to the patient and control group.
Settings and conduct
This study was performed in patients who referred to Baqiyatallah Hospital who underwent surgery to remove a kidney stone.Patients in the patient group will receive the ampoule of transaminase according to a specific schedule, and participants in the control group will receive distilled water by inducing the same drug.
Participants/Inclusion and exclusion criteria
Participants in this study must be between 18 and 60 years old and weigh between 60 and 99 kg, and have no history of anticoagulant use or blood diseases.Therefore, patients under 18 years of age or over 60 years of age and weighing less than 60 kg and over 99 kg, as well as people with a history of anticoagulant use and a history of blood diseases will be excluded from the study.
Intervention groups
In this study, in order to investigate the coagulation effect of transaminase, a 500 mg trans amine ampoule will be used during surgery and also every 8 hours after surgery for 48 hours in the patient group And for the control group, distilled water vial will be used with the same program.
Main outcome variables
Decreased hemoglobin, blood transfusion, change in vital signs, heart attack, stroke, pulmonary thromboembolism, deep vein thrombosis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200526047576N1
Registration date: 2021-04-01, 1400/01/12
Registration timing: registered_while_recruiting

Last update: 2021-04-01, 1400/01/12
Update count: 0
Registration date
2021-04-01, 1400/01/12
Registrant information
Name
seyyedmojtaba mirzadehgoodarzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7710 2386
Email address
seyyedmojtabamirzadeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Study of the Hemostatic Effect of Transamin on percutaneous nephrolithotomy surgery
Public title
effect of transamin in percutaneous nephrolithotomy surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients should be between 18 and 60 years old Patients weigh between 60 kg and 99 kg
Exclusion criteria:
History of anticoagulant use History of blood diseases or HB less than 11 or PLT less than 140000
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize the study, a simple randomization method with individual units is used in such a way that patients are randomly assigned to one of the two intervention and control groups by choosing one of the cards containing code A or B.Cards A and B are each prepared in 32 pieces and placed in 64 exactly the same envelopes randomly and will be sealed.The cards will be placed in envelopes by someone outside the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
in order to avoid targeting and guiding the results, information related to the purpose of the project will be refused to the data analyzer. Efforts will be made to ensure that participants are anonymous and kept secret from the analyst. Participants will be analyzed in two unnamed groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethic committee of baqiyatallah university of medical sciences
Street address
baqiyatallah hospital,sheikh bahaie street, mollasadra Blvd, vanak square.
City
tehran
Province
Tehran
Postal code
1435915371
Approval date
2021-01-09, 1399/10/20
Ethics committee reference number
IR.BMSU.BAQ.REC.1399.046

Health conditions studied

1

Description of health condition studied
kidneys stag horn stone
ICD-10 code
N20.0
ICD-10 code description
calculus of kidney

Primary outcomes

1

Description
Decreased hemoglobin loss
Timepoint
The day before surgery and then daily for 3 days
Method of measurement
Patient tests- series of CBC

Secondary outcomes

1

Description
Hb
Timepoint
Patients' hemoglobin levels will be measured a day before surgery and then daily for three days after surgery.
Method of measurement
Complete blood count

2

Description
blood pressure
Timepoint
every 6 hr
Method of measurement
evaluation of blood pressure

3

Description
heart rate
Timepoint
every 6 hours
Method of measurement
evaluation oh heart rate

4

Description
respiratory rate
Timepoint
every 6 hours
Method of measurement
evaluation of respiratory rate

Intervention groups

1

Description
According to the purpose of the project in the intervention group, 500 mg transamine ampoule containing 500 mg tranexamic acid in 5 ml by injection; During surgery, it will be used by an anesthesiologist and then every 8 hours to 48 hours by a respected research nurse. All patients are examined for vital signs every 6 hours by a respected ward nurse and a detailed description of the changes will be provided. Before starting the project, a training session will be held for all project partners and patients. All medicines will be provided by Caspian Tamin Company. No medication or placebo will be used for the control group.
Category
Treatment - Surgery

2

Description
Control group: in the control group, there will be no intervention in the patient's treatment process, and only to check and compare the control group with the intervention group, the vital signs of patients admitted to this group will be measured every 6 hours by a respected nurse partner. For these patients, a full explanation will be provided before the procedure begins.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Mollasadra street. Vanak.Tehran. Baquatallah Hospital.
Full name of responsible person
Seyyedmojtaba Mirzadeh Goodarzi
Street address
Mollasadra Street. Vanak.
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 81261
Email
Seyyedmojtabamirzadeh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Gholamhossein Alishiri
Street address
Mollasadra street. Vanak
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5250
Email
Seyyedmojtabamirzadeh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Fatemeh Heidari
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Mollasadra Street. Vanak
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5250
Email
Seyyedmojtabamirzadeh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Seyyedmojtaba Mirzadeh Goodarzi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Mollasadra Street. Vanak
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5250
Email
Seyyedmojtabamirzadeh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Seyyedmojtaba Mirzadeh Goodarzi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Mollasadra Street. Vanak
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5250
Email
Seyyedmojtabamirzadeh@yahoo.com

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
Given the need to use the information in this study to create treatment protocols, all cases must be published accurately.
When the data will become available and for how long
Simultaneously with the end of the study
To whom data/document is available
physicians and academic researchers
Under which criteria data/document could be used
The information in this study can be used to create a treatment protocol
From where data/document is obtainable
University dissertations
What processes are involved for a request to access data/document
Due to the use of the information in this study in the university dissertation, the applicants can easily access all the information in this study.
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